Public Assessment Report. Scientific discussion. Levodopa/Carbidopa/Entacapone Teva B.V.

Size: px
Start display at page:

Download "Public Assessment Report. Scientific discussion. Levodopa/Carbidopa/Entacapone Teva B.V."

Transcription

1 Public Assessment Report Scientific discussion Levodopa/Carbidopa/Entacapone Teva B.V. 50 mg/12.5 mg/200 mg 75 mg/18.75 mg/200 mg 100 mg/25 mg/200 mg 125 mg/31.25 mg/200 mg 150 mg/37.5 mg/200 mg 175 mg/43.75 mg/200 mg 200 mg/50 mg/200 mg Film-coated tablets (Levodopa/Carbidopa/Entacapone) DK/H/2350/ /DC 21 June 2016 This module reflects the scientific discussion for the approval of Levodopa/Carbidopa/Entacapone Teva B.V.. The procedure was finalised on 7 August For information on changes after this date please refer to the module Update.

2 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Levodopa/Carbidopa/Entacapone Teva B.V. 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg, 150 mg/37.5 mg/200 mg, 175 mg/43.75 mg/200 mg and 200 mg/50 mg/200 mg film-coated tablets, from Teva B.V. The product is indicated for the treatment of adult patients with Parkinson s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment. A comprehensive description of the indications and posology is given in the SmPC. According to the current understanding, the symptoms of Parkinson s disease are related to depletion of dopamine in the corpus striatum. Dopamine does not cross the blood-brain barrier. Levodopa, the precursor of dopamine, crosses the blood brain barrier and relieves the symptoms of the disease. As levodopa is extensively metabolised in the periphery, only a small portion of a given dose reaches the central nervous system when levodopa is administered without metabolic enzyme inhibitors. Carbidopa and benserazide are peripheral DDC inhibitors which reduce the peripheral metabolism of levodopa to dopamine, and thus, more levodopa is available to the brain. When decarboxylation of levodopa is reduced with the co-administration of a DDC inhibitor, a lower dose of levodopa can be used and the incidence of adverse reactions such as nausea is reduced. With inhibition of the decarboxylase by a DDC inhibitor, catechol-o-methyltransferase (COMT) becomes the major peripheral metabolic pathway catalyzing the conversion of levodopa to 3- Omethyldopa (3-OMD), a potentially harmful metabolite of levodopa. Entacapone is a reversible, specific and mainly peripherally acting COMT inhibitor designed for concomitant administration with levodopa. Entacapone slows the clearance of levodopa from the bloodstream resulting in an increased area under the curve (AUC) in the pharmacokinetic profile of levodopa. Consequently the clinical response to each dose of levodopa is enhanced and prolonged. This decentralised procedure concerns a generic application claiming essential similarity with the reference product Stalevo which has been registered in Europe by Orion Corporation since The marketing authorisation is granted based on article 10(1) of Directive 2001/83/EC. II. QUALITY ASPECTS II.1 Introduction The pharmaceutical form is film-coated tablets and the strength and appearance of the tablets are as follows: 50 mg/12.5 mg/200 mg: Round, biconvex, light brown tablet, marked with 50 on one side, plain on the other. Dimensions: approx. 14 mm diameter. 75 mg/18.75 mg/200 mg: Oval, biconvex, light orange tablet, marked with 75 on one side, plain on the other. Dimensions: approx. 16x10 mm. 100 mg/25 mg mg/200 mg: Oblong, biconvex, pale red tablet, marked with 100 on one side, plain on the other. Dimensions: approx. 17x9 mm. 2/14

3 125 mg/31.25 mg/200 mg: Round, biconvex, yellowish brown tablet, marked with 125 on one side, plain on the other. Dimensions: approx. 14 mm diameter. 150 mg/37.5 mg/200 mg: Oval, biconvex, dark red tablet, marked with 150 on one side, plain on the other. Dimensions: approx. 16x10 mm. 175 mg/43.75 mg/200 mg: Ellipse, biconvex, pale brown tablet, marked with 175 on one side, plain on the other. Dimensions: approx. 17x10 mm 200 mg/50 mg/200 mg: Oblong, biconvex, brown tablet, marked with 200 on one side, plain on the other. Dimensions: approx. 17x9 mm. The product is supplied in white opaque HDPE tablet containers with white opaque PP tamper evident (TE) or tamper-evident/senior friendly (TE/SF) or tamper evident/child resistant/senior friendly (TE/CR/SF) screw cap with desiccant insert in pack-sizes of: 10, 28, 30, 50, 60, 90, 98, 100, 130, 150, 175, 200 and 250 film-coated tablets. However, not all pack sizes may be marketed. The tablet core contains: Microcrystalline cellulose; Lactose anhydrous; Hydroxypropylcellulose; Povidone (K-30); Silica, colloidal anhydrous and Magnesium stearate. The film-coating consists of: 50 mg/12.5 mg/200 mg: Opadry 13M containing: Titanium dioxide (E171), Hypromellose Glycerol (E422) Iron oxide yellow (E172) Polysorbate 80 Iron oxide red (E172) Iron oxide black (E172) Magnesium stearate 75 mg/18.75 mg/200 mg: Opadry 13M containing: Titanium dioxide (E171) Hypromellos Glycerol (E422) Iron oxide yellow (E172) Polysorbate 80 Iron oxide red (E172) Magnesium stearate 100 mg/25 mg mg/200 mg: Opadry 13M containing: Titanium dioxide (E171) Hypromellose Glycerol (E422) Polysorbate 80 Allura red ac (E129) Carmine (E120) Magnesium stearate 125 mg/31.25 mg/200 mg: Opadry 13M containing: Titanium dioxide (E171) Hypromellose, Glycerol (E422) Iron oxide yellow (E172) Polysorbate 80 Iron oxide red (E172) Magnesium stearate 150 mg/37.5 mg/200 mg: Opadry 13M containing: Titanium dioxide (E171) 3/14

4 Hypromellose Glycerol (E422) Polysorbate 80 Iron oxide red (E172) Carmoisine (E122) Magnesium stearate 175 mg/43.75 mg/200 mg: Opadry 13M containing: Titanium dioxide (E171) Hypromellose Glycerol (E422) yellow iron oxide (E172) Polysorbate 80 Iron oxide red (E172) Iron oxide black (E172) Magnesium stearate 200 mg/50 mg/200 mg: Opadry 13M containing: Titanium dioxide (E171) Hypromellose Glycerol (E422) Iron oxide yellow (E172) Polysorbate 80 Iron oxide red (E172) Iron oxide black (E172) Magnesium stearate The RMS has been assured that acceptable standards of GMP (see Directive 2003/94/EC) are in place for this product type at all sites responsible for the manufacturing of the active substance as well as for the manufacturing and assembly of this product prior to granting its national authorisation. II.2 Drug Substance The finished product contains 3 drug substances: Levadopa, carbidopa and entacapone. The documentation on the drug substance levadopa is covered by a CEP. Levodopa is described in the European Pharmacopoeia, and in-house specifications have been established. A compiled specification is presented. Based on the presented stability studies, an appropriate re-test period has been set. The documentation on the drug substance carbidopa is covered by a CEP. The applicant specification has been provided and is found acceptable. The drug substance entacapone is covered by a CEP. The applicant specification has been provided and is found acceptable. II.3 Medicinal Product The product is film-coated tablets and is available in 7 strengths. All strengths contain 200 mg entacapone and proportional content of levodopa and carbidopa with a ratio of 4:1. The pharmaceutical development work is described in detail. The formulation is chosen in order to resemble the reference product with regard to content of active substance, but the other excipients and mass of tablets differ. The development was based on bioequivalence studies; the reference product and 4/14

5 applied products have different dissolution profiles but are similar with respect to bioequivalence. The discriminating power of the dissolution method was demonstrated, the development of the manufacturing process described and explanation for selection of the final formulation given. The impurity profile of the applied product and reference product are compared and found to be almost similar with respect to the specified impurities. The manufacturing process has been described and justified by validation. Bulk storage period is applied and stability data are provided. The bulk storage period is accepted. The product specification covers appropriate parameters for this dosage form and is found acceptable. Acceptable validations of the analytical methods have been presented. Batch analysis has been performed on 2-3 pilot scale batches of each strength. The batch analysis results show that the finished products meet the specifications. The proposed shelf-life of the unopened product of 2 years with no special storage conditions is acceptable. Data for in-use stability and photostability have been presented. III. NON-CLINICAL ASPECTS III.1 Introduction Pharmacodynamic, pharmacokinetic and toxicological properties of levodopa, carbidopa and entacapone are well known. As levodopa, carbidopa and entacapone are widely used well-known active substances, the MAH has not provided additional studies and further studies are not required. Overview based on literature review is, thus, appropriate. The non-clinical overview report refers numerous publications up to year The non-clinical overview on the pre-clinical pharmacology, pharmacokinetics and toxicology is adequate. III.2 Ecotoxicity/environmental risk assessment (ERA) The product is intended as a substitute for other identical products on the market. The approval of this product will not result in an increase in the total quantity of levodopa, carbidopa and entacapone released into the environment. It does not contain any component, which results in an additional hazard to the environment during storage, distribution, use and disposal. IV. CLINICAL ASPECTS IV.1 Introduction Levodopa, carbidopa and entacapone are well-known active substances with established efficacy and tolerability. As Levodopa, carbidopa and entacapone are widely used, well-known active substances, the MAH has not provided additional studies (apart from supportive bioequivalence studies referenced below) and further studies are not required. Overview based on literature review is, thus, appropriate. The clinical overview report refers numerous publications up to year 2013.The clinical overview on the clinical pharmacology, efficacy and safety is adequate. 5/14

6 Biowaiver Levodopa/Carbidopa/Entacapone Teva B.V. film-coated tablets are presented in seven strength combinations. The bioequivalence studies were carried out with the lowest and highest strengths applied for i.e. 50 mg/12.5 mg/200 mg and 200 mg/50 mg/200 mg. A waiver of bioequivalence studies with the additional strengths was applied for and was adequately justified. Bioequivalence study To support the application, the MAH has submitted as report 2 pivotal and 2 pilot bioequivalence studies. Pivotal bioequivalence studies: - 50 mg/12.5 mg/200 mg, fully replicated crossover study under fasting conditions mg/50 mg/200 mg, fully replicated crossover study under fasting conditions. Pilot studies: - 50 mg/12.5 mg/200 mg, single-dose, four period, four treatment crossover study under fasting conditions to evaluate BE between three test formulations and the reference product mg/50 mg/200 mg, single-dose, four period, four treatment crossover study under fasting conditions to evaluate BE between three test formulations and the reference product. The two pilot studies aimed to select the optimal formulation of the fixed combination product. For the pilot studies only the study synopsis is presented. Pivotal studies The pivotal bioequivalence studies were open-label, randomized, two-treatment, four-sequence, four period, four-way replicated crossover, single-dose bioavailability studies conducted under fasting conditions with a wash out period of 7 days between the administrations. 50 mg/12.5 mg/200 mg study The study was an open-label, randomized, two-treatment, four-sequence, four-period, four-way replicated crossover, single-dose bioavailability study conducted under fasting conditions with a wash out period of 7 days between the administrations. One film-coated tablet of 50/12.5/200 mg of either the test product Levodopa/Carbidopa/Entacapone Teva B.V. or the reference product Stalevo film-coated tablets, Orion Corporation, from the German market was administered in each period. 70 healthy subjects participated in the study. 61 subjects completed all 4 periods of the study. In accordance with the study protocol, data from all subjects who completed at least 2 periods, including one test and one reference, and for whom the PK profile was adequately characterized were used for PK and statistical analyses (N=68). For levodopa, the PK population included the first 20 subjects of each main group (20/30 and 20/40) completing the first 2 periods, and for whom the PK profile could be adequately characterised. Pharmacokinetic population: N=40 for Levodopa N=68 for Carbidopa N=68 for Entacapone Primary variables were AUC 0-t and C max. Criteria for bioequivalence for levodopa: 90% geometric confidence intervals of the ratio (A/B) of least-squares means from the ANOVA of the ln-transformed AUC 0-t and C max should be within 80.00% to %. Criteria for bioequivalence for carbidopa and entacapone: The 90% geometric confidence intervals of the ratio (A/B) of LS means of the ln-transformed AUC 0-t should be within 80.00% to %; If the within-subject coefficient of variation of the reference product (CVWR) is 30% for C max, then the 90% geometric confidence intervals of the ratio (A/B) of LS means of the lntransformed C max should be within 80.00% to %. Otherwise, if the CVWR is > 30% for C max, a scaled-average bioequivalence criterion should be 6/14

7 Results Levodopa used for this parameter. The test-to-reference geometric mean ratio (A/B) should lie within the conventional acceptance range of %. The acceptance criteria for the 90% geometric confidence intervals of the ratio (A/B) of LS means for C max could be widened based upon the reference within-subject variability to a maximum of %. Table 1. Summary of pharmacokinetic parameters for levodopa for each treatment Table 2. Ratios, 90% geometric confidence intervals for AUC 0-t, AUC 0-inf and C max for levodopa 7/14

8 Carbidopa Table 3. Summary of pharmacokinetic parameters for carbidopa for each treatment Table 4. Ratios, 90% geometric confidence intervals for AUC 0-t, AUC 0-inf and C max for carbidopa 8/14

9 Table 5. Summary of pharmacokinetic parameters for entacapone for each treatment Table 6. Ratios, 90% geometric confidence intervals for AUC 0-t, AUC 0-inf and C max for entacapone For all three analytes levodopa, carbidopa and entacapone the 90% confidence interval was within the conventional acceptance limits of %; therefore, although the CV% for C max for entacapone was >30%, no scaling for widening of the acceptance limits as considered in the protocol was performed. 200 mg/50 mg/200 mg study The study was an open-label, randomized, four-treatment, two-sequence, four-period, four-way replicated crossover, single-dose bioavailability study conducted under fasting conditions with a wash out period of 7 days between the administrations. One film-coated tablet of 200/50/200 mg of either the test product Levodopa/Carbidopa/Entacapone Teva B.V. or the reference product Stalevo film-coated tablets, Orion Corporation, from the German market was administered in each period. 60 healthy subjects participated in the study. 35 subjects completed all 4 periods of the study. Pharmacokinetic population: N=20 for Levodopa N=45 for Carbidopa N=55 for Entacapone 9/14

10 Primary variables were AUC 0-t and C max. Criteria for bioequivalence levodopa: 90% geometric confidence intervals of the ratio (A/B) of least-squares means from the ANOVA of the ln-transformed AUC 0-t and C max should be within 80.00% to %. Criteria for bioequivalence for carbidopa and entacapone: The 90% geometric confidence intervals of the ratio (A/B) of LS means of the ln-transformed AUC 0-t should be within 80.00% to %; If the within-subject coefficient of variation of the reference product (CVWR) is 30% for C max, then the 90% geometric confidence intervals of the ratio (A/B) of LS means of the lntransformed C max should be within 80.00% to %. Otherwise, if the CVWR is > 30% for C max, a scaled-average bioequivalence criterion should be used for this parameter. The test-to-reference geometric mean ratio (A/B) should lie within the conventional acceptance range of %. The acceptance criteria for the 90% geometric confidence intervals of the ratio (A/B) of LS means for C max could be widened based upon the reference within-subject variability to a maximum of %. Results Levodopa Table 7. Summary of pharmacokinetic parameters for levodopa for each treatment Table 8. Ratios, 90% geometric confidence intervals for AUC 0-t, AUC 0-inf and C max for levodopa 10/14

11 Carbidopa Table 9. Summary of pharmacokinetic parameters for carbidopa for each treatment Table 10. Ratios, 90% geometric confidence intervals for AUC 0-t, AUC 0-inf and C max for carbidopa 11/14

12 Table 11. Summary of pharmacokinetic parameters for entacapone for each treatment Table 12. Ratios, 90% geometric confidence intervals for AUC 0-t, AUC 0-inf and C max for entacapone 12/14

13 For all three analytes levodopa, carbidopa and entacapone the 90% confidence interval was within the conventional acceptance limits of %; therefore, although the CV% for C max for entacapone was >30% no scaling was performed. Pharmacokinetic conclusion Based on the submitted bioequivalence studies Levodopa/Carbidopa/Entacapone Teva B.V. 50/12.5/200 mg and 200/50/200 mg film-coated tablets are considered bioequivalent with Stalevo 50/12.5/200 mg and 200/50/200 mg film-coated tablets. The results of the study with 200 mg/50 mg/ 200 mg formulation and 50 mg/12.5 mg/200 mg formulation can be extrapolated to the other strengths 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg, 150 mg/37.25 mg/200 mg and 175 mg/43.75 mg/200 mg, according to conditions in Guideline on the Investigation of Bioequivalence CPMP/EWP/QWP/1401/98 Rev. 1/Corr*, section The RMS has been assured that the bioequivalence study has been conducted in accordance with acceptable standards of Good Clinical Practice (GCP, see Directive 2005/28/EC) and Good Laboratory Practice (GLP, see Directives 2004/9/EC and 2004/10/EC). IV.2 Risk Management Plan The MAH has submitted a risk management plan, in accordance with the requirements of Directive 2001/83/EC as amended, describing the pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to Levodopa/Carbidopa/Entacapone Teva B.V.. The following summary list of safety concerns has been agreed with no additional pharmacovigilance or risk minimisation measures: Table 1: Summary table of safety concerns as approved in RMP V. USER CONSULTATION The package leaflet has been evaluated via a user consultation study in accordance with the requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC. The language used for the purpose of user testing the PIL was English. 13/14

14 The results show that the package leaflet meets the criteria for readability as set out in the Guideline on the readability of the label and package leaflet of medicinal products for human use. The test consisted of a pilot test with 2 participants, followed by two rounds with 10 participants each. The questions covered the following areas sufficiently: traceability, comprehensibility and applicability. VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Levodopa/Carbidopa/Entacapone Teva B.V. film-coated tablets has a proven chemicalpharmaceutical quality and is comparable to Stalevo. Stalevo is a well-known medicinal product with an established favourable efficacy and safety profile. Bioequivalence has been shown to be in compliance with the requirements of European guidance documents. Agreement between Member States was reached during a written procedure. There was no discussion in the CMD(h). The Concerned Member States, on the basis of the data submitted, considered that a marketing authorisation for Levodopa/Carbidopa/Entacapone Teva B.V. could be granted. The decentralised procedure was finalised on 7 August Levodopa/Carbidopa/Entacapone Teva B.V. was authorised in Denmark on 8 October According to the List of Union reference dates and frequency of submission of periodic safety update reports (PSURs), no routine PSURs are required for this product. The date for the first renewal will be: 17 October There were no post-approval commitments made during the procedure. 14/14

Public Assessment Report. Scientific discussion. Paracetamol Orifarm 500 mg film-coated tablets. (Paracetamol) DK/H/2271/001/DC.

Public Assessment Report. Scientific discussion. Paracetamol Orifarm 500 mg film-coated tablets. (Paracetamol) DK/H/2271/001/DC. Public Assessment Report Scientific discussion Paracetamol Orifarm 500 mg film-coated tablets (Paracetamol) DK/H/2271/001/DC 15 October 2014 This module reflects the scientific discussion for the approval

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Levodopa/Carbidopa/Entacapone Accord 100 mg/25 mg/200 mg Film-coated tablets Levodopa/Carbidopa/Entacapone Accord 150 mg/37.5 mg/200 mg Film-coated tablets

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Levodopa/Carbidopa/Entacapone Torrent 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/Carbidopa/Entacapone Torrent, 75 mg/18.75 mg/200 mg film-coated

More information

Public Assessment Report. Scientific discussion. Desloracell 5 mg, film-coated tablet. (desloratadine) NL License RVG: 112807

Public Assessment Report. Scientific discussion. Desloracell 5 mg, film-coated tablet. (desloratadine) NL License RVG: 112807 Public Assessment Report Scientific discussion Desloracell 5 mg, film-coated tablet (desloratadine) NL License RVG: 112807 Date: 6 July 2015 This module reflects the scientific discussion for the approval

More information

Public Assessment Report. Scientific discussion. Atorvastatin DK/H/1744/001-004/DC

Public Assessment Report. Scientific discussion. Atorvastatin DK/H/1744/001-004/DC Public Assessment Report Scientific discussion Atorvastatin Orifarm 10 mg 20 mg, 40 mg and 80 mg film-coated tablets Atorvastatin DK/H/1744/001-004/DC This module reflects the scientific discussion for

More information

Public Assessment Report UKPAR

Public Assessment Report UKPAR Public Assessment Report UKPAR Amitriptyline 10 mg film-coated tablets Amitriptyline 25 mg film-coated tablets Amitriptyline 50 mg film-coated tablets (Amitriptyline hydrochloride) UK Licence No: PL 17907/0131-133

More information

Lacidipine 2 mg Film-Coated Tablets PL 08553/0502. Lacidipine 4 mg Film-Coated Tablets PL 08553/0503. UK Public Assessment Report

Lacidipine 2 mg Film-Coated Tablets PL 08553/0502. Lacidipine 4 mg Film-Coated Tablets PL 08553/0503. UK Public Assessment Report Lacidipine 2 mg Film-Coated Tablets PL 08553/0502 Lacidipine 4 mg Film-Coated Tablets PL 08553/0503 UK Public Assessment Report TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken

More information

Public Assessment Report. UK National Procedure. Perindopril 2 mg Tablets. Perindopril 4 mg Tablets. Perindopril 8 mg Tablets PL 20075/0294-0296

Public Assessment Report. UK National Procedure. Perindopril 2 mg Tablets. Perindopril 4 mg Tablets. Perindopril 8 mg Tablets PL 20075/0294-0296 Public Assessment Report UK National Procedure Perindopril 2 mg Tablets Perindopril 4 mg Tablets Perindopril 8 mg Tablets PL 20075/0294-0296 Accord Healthcare Limited 1 LAY SUMMARY This is a summary of

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure TELMISARTAN DR REDDY S 20 MG TABLETS TELMISARTAN DR REDDY S 40 MG TABLETS TELMISARTAN DR REDDY S 80 MG TABLETS (telmisartan) Procedure No: UK/H/5034/001-003/DC

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Levetiracetam 250 mg film-coated tablets PL 36390/0168; UK/H/5630/001/DC Levetiracetam 500 mg film-coated tablets PL 36390/0169; UK/H/5630/002/DC Levetiracetam

More information

Public Assessment Report. Scientific discussion. Ramipril Teva 1.25 mg, 2.5 mg, 5 mg and 10 mg tablets Ramipril DK/H/2130/001-004/DC.

Public Assessment Report. Scientific discussion. Ramipril Teva 1.25 mg, 2.5 mg, 5 mg and 10 mg tablets Ramipril DK/H/2130/001-004/DC. Public Assessment Report Scientific discussion Ramipril Teva 1.25 mg, 2.5 mg, 5 mg and 10 mg tablets Ramipril DK/H/2130/001-004/DC 3 April 2014 Tis module reflects te scientific discussion for te approval

More information

Public Assessment Report. Decentralised Procedure. Sildenafil Dr. Reddy s 25, 50 and 100mg Filmcoated. Sildenafil citrate UK/H/4855/001-3/DC

Public Assessment Report. Decentralised Procedure. Sildenafil Dr. Reddy s 25, 50 and 100mg Filmcoated. Sildenafil citrate UK/H/4855/001-3/DC Public Assessment Report Decentralised Procedure Sildenafil Dr. Reddy s 25, 50 and 100mg Filmcoated Sildenafil citrate UK licence no: PL 08553/0468-70 DR Reddy s Laboratories (UK) Limited 1 LAY SUMMARY

More information

FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT

FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE FOR A VETERINARY MEDICINAL PRODUCT VIRBAKOR 20 mg film-coated tablet for dogs Date: 03/11/2014 French agency for food, environnemental

More information

Summary Public Assessment Report. Generics

Summary Public Assessment Report. Generics Summary Public Assessment Report Generics 875 mg + 125 mg, Film-coated tablets (Amoxicillin Trihydrate + Potassium Clavulanate) Date: 29-12-2014 1/7 Summary Public Assessment Report Generics Amoxicillin

More information

Summary Public Assessment Report. Generics. Amoxicilina + Ácido Clavulânico Ranbaxy,

Summary Public Assessment Report. Generics. Amoxicilina + Ácido Clavulânico Ranbaxy, Summary Public Assessment Report Generics Amoxicilina + Ácido Clavulânico Ranbaxy 875 mg + 125 mg, Film-coated tablets (Amoxicillin Trihydrate + Potassium Clavulanate) Date: 29-12-2014 1/7 Summary Public

More information

Public Assessment Report. Decentralised Procedure. Cefuroxime 250mg and 500mg film-coated tablets. Cefuroxime 500mg film-coated tablets

Public Assessment Report. Decentralised Procedure. Cefuroxime 250mg and 500mg film-coated tablets. Cefuroxime 500mg film-coated tablets Public Assessment Report Decentralised Procedure Cefuroxime 250mg film-coated tablets Cefuroxime 500mg film-coated tablets Procedure No: UK Licence No: PL 35646/0020-0021 Alkem Pharma GmbH 1 LAY SUMMARY

More information

Public Assessment Report Scientific discussion. Levetiracetam Krka (Levetiracetam) SE/H/1067/01-04/DC

Public Assessment Report Scientific discussion. Levetiracetam Krka (Levetiracetam) SE/H/1067/01-04/DC Public Assessment Report Scientific discussion Levetiracetam Krka (Levetiracetam) SE/H/1067/01-04/DC This module reflects the scientific discussion for the approval of Levetiracetam Krka. The procedure

More information

Public Assessment Report Scientific discussion. Tenofovir disoproxil Teva (tenofovir disoproxil) SE/H/1432/01/DC

Public Assessment Report Scientific discussion. Tenofovir disoproxil Teva (tenofovir disoproxil) SE/H/1432/01/DC Public Assessment Report Scientific discussion Tenofovir disoproxil Teva (tenofovir disoproxil) SE/H/1432/01/DC This module reflects the scientific discussion for the approval of Tenofovir disoproxil Teva.

More information

Public Assessment Report. UK National Procedure. (colecalciferol) PL 16508/0047 PL 16508/0048. ProStrakan Ltd.

Public Assessment Report. UK National Procedure. (colecalciferol) PL 16508/0047 PL 16508/0048. ProStrakan Ltd. Public Assessment Report UK National Procedure STEXEROL-D 3 1,000 IU FILM-COATED TABLETS STEXEROL-D 3 25,000 IU FILM-COATED TABLETS (colecalciferol) PL 16508/0047 PL 16508/0048 ProStrakan Ltd. 1 LAY SUMMARY

More information

Public Assessment Report. Scientific discussion. Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules

Public Assessment Report. Scientific discussion. Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules Public Assessment Report Scientific discussion Calcium and Vitamine D3 Alpex 1000 mg/880 IE, effervescent granules (calcium carbonate and cholecalciferol) NL License RVG: 111783 Date: 12 March 2015 This

More information

HYDROCORTISONE 10 MG TABLETS

HYDROCORTISONE 10 MG TABLETS HYDROCORTISONE 10 MG TABLETS (Hydrocortisone) PL 20072/0238 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after authorisation summary

More information

Public Assessment Report. Decentralised Procedure PARACETAMOL 1000 MG TABLETS. Procedure No: UK/H/5004/01/DC. UK Licence No: PL 18866/0060

Public Assessment Report. Decentralised Procedure PARACETAMOL 1000 MG TABLETS. Procedure No: UK/H/5004/01/DC. UK Licence No: PL 18866/0060 Public Assessment Report Decentralised Procedure PARACETAMOL 1000 MG TABLETS Procedure No: UK Licence No: PL 18866/0060 Rockspring Healthcare Ltd LAY SUMMARY On 17 January 2013 the Medicines and Healthcare

More information

TRAMADOL HYDROCHLORIDE AND PARACETAMOL 37.5 MG/325 MG FILM-COATED TABLETS (tramadol hydrochloride and paracetamol ) PL 30684/0222 UKPAR

TRAMADOL HYDROCHLORIDE AND PARACETAMOL 37.5 MG/325 MG FILM-COATED TABLETS (tramadol hydrochloride and paracetamol ) PL 30684/0222 UKPAR TRAMADOL HYDROCHLORIDE AND PARACETAMOL 37.5 MG/325 MG FILM-COATED TABLETS (tramadol hydrochloride and paracetamol ) PL 30684/0222 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4

More information

Public Assessment Report Scientific discussion. Amitriptylin Abcur (amitriptyline hydrochloride) Asp no : 2013-0678 2013-0679 2013-0680

Public Assessment Report Scientific discussion. Amitriptylin Abcur (amitriptyline hydrochloride) Asp no : 2013-0678 2013-0679 2013-0680 Public Assessment Report Scientific discussion Amitriptylin Abcur (amitriptyline hydrochloride) Asp no : 2013-0678 2013-0679 2013-0680 This module reflects the scientific discussion for the approval of

More information

Decentralised Procedure. Public Assessment Report

Decentralised Procedure. Public Assessment Report Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report ben-u-ron direkt Erdbeer/Vanille 250/500 mg Granulat in Beuteln ben-u-ron direkt Cappuccino 500/1000

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Amlodipine Pfizer 5 mg tablets Amlodipine Pfizer 10 mg tablets Amlodipine Pfizer 5 mg hard capsules Amlodipine Pfizer 10 mg hard capsules Procedure No:

More information

Public Assessment Report. Scientific discussion. Apotel 10 mg/ml, solution for infusion. (paracetamol) NL/H/2857/001/DC

Public Assessment Report. Scientific discussion. Apotel 10 mg/ml, solution for infusion. (paracetamol) NL/H/2857/001/DC Public Assessment Report Scientific discussion Apotel 10 mg/ml, solution for infusion (paracetamol) NL/H/2857/001/DC Date: 16 December 2014 This module reflects the scientific discussion for the approval

More information

Public Assessment Report Scientific discussion. Prednisolon Alternova (previous Prednisolon E Consult) (prednisolone) Asp no: 2011-0921

Public Assessment Report Scientific discussion. Prednisolon Alternova (previous Prednisolon E Consult) (prednisolone) Asp no: 2011-0921 Public Assessment Report Scientific discussion Prednisolon Alternova (previous Prednisolon E Consult) (prednisolone) Asp no: 2011-0921 This module reflects the scientific discussion for the approval of

More information

Public Assessment Report. Decentralised Procedure. Tenofovir Zentiva 245 mg Film-coated Tablets. Tenofovir disoproxil fumarate UK/H/4970/001/DC

Public Assessment Report. Decentralised Procedure. Tenofovir Zentiva 245 mg Film-coated Tablets. Tenofovir disoproxil fumarate UK/H/4970/001/DC Public Assessment Report Decentralised Procedure Tenofovir Zentiva 245 mg Film-coated Tablets Tenofovir disoproxil fumarate UK licence no: PL 17780/0573 Winthrop Pharmaceuticals UK Limited 1 LAY SUMMARY

More information

PUBLIC ASSESSMENT REPORT Scientific Discussion. Perindopril arginine Amlodipine FR/H/325-326-327/01-04/DC. Applicant: Servier

PUBLIC ASSESSMENT REPORT Scientific Discussion. Perindopril arginine Amlodipine FR/H/325-326-327/01-04/DC. Applicant: Servier Direction de l Evaluation des Médicaments et des Produits Biologiques PUBLIC ASSESSMENT REPORT Scientific Discussion COVERAM PERINDOPRIL ARGININE - AMLODIPINE SERVIER PERINDOPRIL ARGININE AMLODIPINE BIOPHARMA

More information

Public Assessment Report. Scientific discussion. Atorvastatine Glob 10 mg,20 mg, 40 mg, and 80 mg, film-coated tablets

Public Assessment Report. Scientific discussion. Atorvastatine Glob 10 mg,20 mg, 40 mg, and 80 mg, film-coated tablets Public Assessment Report Scientific discussion Atorvastatine Glob 10 mg,20 mg, 40 mg, and 80 mg, film-coated tablets (Atorvastatin calcium trihydrate) NL/H/2994/001-004/DC Date: 16 March 2015 This module

More information

MIGRAINE RELIEF 342 MG FILM-COATED TABLETS PL 20154/0030 UKPAR TABLE OF CONTENTS

MIGRAINE RELIEF 342 MG FILM-COATED TABLETS PL 20154/0030 UKPAR TABLE OF CONTENTS MIGRAINE RELIEF 342 MG FILM-COATED TABLETS PL 20154/0030 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 13 Steps taken after authorisation summary

More information

Public Assessment Report. Scientific discussion. Paracetamol Alternova 500 mg, 650 mg, 1 g (paracetamol) Asp no: 2012-0005, 2012-0006, 2012-0007

Public Assessment Report. Scientific discussion. Paracetamol Alternova 500 mg, 650 mg, 1 g (paracetamol) Asp no: 2012-0005, 2012-0006, 2012-0007 Public Assessment Report Scientific discussion Paracetamol Alternova 500 mg, 650 mg, 1 g (paracetamol) Asp no: 2012-0005, 2012-0006, 2012-0007 Applicant: E Consult ApS, Denmark This module reflects the

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure LANSOPRAZOLE 15 MG AND 30 MG ORODISPERSIBLE TABLETS (lansoprazole) Procedure No: UK Licence No: PL 35507/0118-0119 Lupin (Europe) Limited LAY SUMMARY Lansoprazole

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Paracetamol 500 mg effervescent tablets Procedure No: UK/H/5662/001-002/DC UK Licence No: PL 36390/0177-0178 Cipla (EU) Limited Lay Summary Paracetamol

More information

Public Assessment Report. Scientific discussion. Paracetamol Apofri 500 mg (paracetamol) Asp no: 2012-0676. Applicant: E Consult ApS, Denmark

Public Assessment Report. Scientific discussion. Paracetamol Apofri 500 mg (paracetamol) Asp no: 2012-0676. Applicant: E Consult ApS, Denmark Public Assessment Report Scientific discussion Paracetamol Apofri 500 mg (paracetamol) Asp no: 2012-0676 Applicant: E Consult ApS, Denmark This module reflects the scientific discussion for the approval

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Atorvastatin 10 mg film-coated Tablets Atorvastatin 20 mg film-coated Tablets Atorvastatin 40 mg film-coated Tablets Atorvastatin 80 mg film-coated Tablets

More information

Public Assessment Report. Scientific discussion

Public Assessment Report. Scientific discussion Public Assessment Report Scientific discussion 1) Risedronat Actavis 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten 2) Bifodron 5 mg Filmtabletten, 30 mg Filmtabletten,

More information

Compilation of individual product-specific guidance on demonstration of bioequivalence

Compilation of individual product-specific guidance on demonstration of bioequivalence 17 December 2014 EMA/CHMP/736403/2014 Committee for Medicinal Products for Human Use (CHMP) Compilation of individual product-specific guidance on demonstration of bioequivalence Initial batch of individual

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Olopatadine Zentiva 1 mg/ml eye drops, solution (olopatadine hydrochloride) Procedure No: UK Licence No: PL 17780/0568 Winthrop Pharmaceuticals UK Limited

More information

Fexofenadine Hydrochloride 120 mg Film-coated Tablets Fexofenadine Hydrochloride 180 mg Film-coated Tablets PL 36390/0053-4 UKPAR TABLE OF CONTENTS

Fexofenadine Hydrochloride 120 mg Film-coated Tablets Fexofenadine Hydrochloride 180 mg Film-coated Tablets PL 36390/0053-4 UKPAR TABLE OF CONTENTS Fexofenadine Hydrochloride 120 mg Film-coated Tablets Fexofenadine Hydrochloride 180 mg Film-coated Tablets PL 36390/0053-4 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 5 Steps

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure BOSENTAN ZENTIVA 62.5 MG FILM-COATED TABLETS BOSENTAN ZENTIVA 125 MG FILM-COATED TABLETS BOSENTAN ZENTIVA 62.5 MG FILM-COATED TABLETS BOSENTAN ZENTIVA 125

More information

Public Assessment Report. Scientific discussion. Lercanidipinhydrochlorid Sandoz 10 mg and 20 mg film-coated tablets. (Lercanidipine hydrochloride)

Public Assessment Report. Scientific discussion. Lercanidipinhydrochlorid Sandoz 10 mg and 20 mg film-coated tablets. (Lercanidipine hydrochloride) Public Assessment Report Scientific discussion Lercanidipinydroclorid Sandoz 10 mg and 20 mg film-coated tablets (Lercanidipine ydrocloride) DK/H/2360/001-002/DC 1 December 2015 Tis module reflects te

More information

Decentralised Procedure. Public Assessment Report. Paracetamol-ratiopharm 10 mg/ml Infusionslösung Paracetamol DE/H/1908/001/DC

Decentralised Procedure. Public Assessment Report. Paracetamol-ratiopharm 10 mg/ml Infusionslösung Paracetamol DE/H/1908/001/DC Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Paracetamol-ratiopharm 10 mg/ml Infusionslösung Paracetamol DE/H/1908/001/DC Applicant: TEVA Pharma

More information

Ibuprofen 200mg Soft Capsules PL 03105/0105 UKPAR

Ibuprofen 200mg Soft Capsules PL 03105/0105 UKPAR Ibuprofen 200mg Soft Capsules PL 03105/0105 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 13 Summary of Product Characteristics Page 14 Patient

More information

Public Assessment Report. Decentralised Procedure. Cefadroxil 250 mg/5 ml granules for oral. (Cefadroxil monohydrate)

Public Assessment Report. Decentralised Procedure. Cefadroxil 250 mg/5 ml granules for oral. (Cefadroxil monohydrate) Public Assessment Report Decentralised Procedure Cefadroxil 250 mg/5 ml granules for oral suspension (Cefadroxil monohydrate) UK licence no: PL 34088/0033 Alkaloid-INT d.o.o. 1 Cefadroxil 250 mg/5 ml granules

More information

Public Assessment Report

Public Assessment Report Public Assessment Report Decentralised Procedure Ibuprofen and phenylephrine hydrochloride 200mg/5mg film-coated tablets Procedure No: UK Licence No: PL 17780/0563 Winthrop Pharmaceuticals UK Limited LAY

More information

Omeprazole 20 mg gastro-resistant tablets PL 14017/0277

Omeprazole 20 mg gastro-resistant tablets PL 14017/0277 Omeprazole 20 mg gastro-resistant tablets PL 14017/0277 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 11 Steps Taken After Initial Authorisation

More information

How To Market Pantoprazol Beximco

How To Market Pantoprazol Beximco Public Assessment Report Scientific discussion Pantoprazol Beximco 20 mg and 40 mg, gastro-resistant tablets (pantoprazole) NL/H/2751/001-002/DC Date: 27 August 2014 This module reflects the scientific

More information

Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130

Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130 Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 12 Summary of Product Characteristics

More information

Phynova Joint and Muscle Relief Tablets THR 41783/0001 UKPAR

Phynova Joint and Muscle Relief Tablets THR 41783/0001 UKPAR Phynova Joint and Muscle Relief Tablets THR 41783/0001 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Summary of Product Characteristics Page

More information

NEUROTONE THR 00904/0005 UKPAR

NEUROTONE THR 00904/0005 UKPAR NEUROTONE THR 00904/0005 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Summary of Product Characteristics Page 11 Product Information Leaflet

More information

Public Assessment Report UKPAR. Levonorgestrel 1.5 mg tablet. (levonorgestrel). UK Licence No: PL 41947/0006. ELC Group s.r.o.

Public Assessment Report UKPAR. Levonorgestrel 1.5 mg tablet. (levonorgestrel). UK Licence No: PL 41947/0006. ELC Group s.r.o. Public Assessment Report UKPAR Levonorgestrel 1.5 mg tablet (levonorgestrel). UK Licence No: PL 41947/0006 ELC Group s.r.o. 1 LAY SUMMARY Levonorgestrel 1.5 mg tablet (Levonorgestrel, tablet, 1.5 mg) This

More information

Ascorbic Acid 50 mg Tablets. Ascorbic Acid 100 mg Tablets. Ascorbic Acid 200 mg Tablets. Ascorbic Acid 500 mg Tablets PL 20416/0286 PL 20416/0287

Ascorbic Acid 50 mg Tablets. Ascorbic Acid 100 mg Tablets. Ascorbic Acid 200 mg Tablets. Ascorbic Acid 500 mg Tablets PL 20416/0286 PL 20416/0287 Ascorbic Acid 50 mg Tablets Ascorbic Acid 100 mg Tablets Ascorbic Acid 200 mg Tablets Ascorbic Acid 500 mg Tablets PL 20416/0286 PL 20416/0287 PL 20416/0288 PL 20416/0289 UKPAR TABLE OF CONTENTS Lay Summary

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure IMATINIB TEVA UK 100 MG FILM-COATED TABLETS IMATINIB TEVA UK 400 MG FILM-COATED TABLETS (imatinib mesilate) Procedure No: UK Licence No: PL 00289/1516-1517

More information

Public Assessment Report Scientific discussion. Prednisolon Pilum (prednisolone) Asp no: 2013-0498

Public Assessment Report Scientific discussion. Prednisolon Pilum (prednisolone) Asp no: 2013-0498 Public Assessment Report Scientific discussion Prednisolon Pilum (prednisolone) Asp no: 2013-0498 This module reflects the scientific discussion for the approval of Prednisolon Pilum. The procedure was

More information

Public Assessment Report. Decentralised Procedure. Omeprazole 10mg Gastro-resistant Capsules, hard. Omeprazole 20mg Gastro-resistant Capsules, hard

Public Assessment Report. Decentralised Procedure. Omeprazole 10mg Gastro-resistant Capsules, hard. Omeprazole 20mg Gastro-resistant Capsules, hard Public Assessment Report Decentralised Procedure Omeprazole 10mg Gastro-resistant Capsules, hard Omeprazole 20mg Gastro-resistant Capsules, hard Omeprazole 40mg Gastro-resistant Capsules, hard (UK/H/4423/001-003/DC)

More information

Public Assessment Report. Scientific discussion. Ibuprofen Sandoz 200 mg and 400 mg, capsules, soft. (ibuprofen) NL/H/2810/001-002/MR

Public Assessment Report. Scientific discussion. Ibuprofen Sandoz 200 mg and 400 mg, capsules, soft. (ibuprofen) NL/H/2810/001-002/MR Public Assessment Report Scientific discussion Ibuprofen Sandoz 200 mg and 400 mg, capsules, soft (ibuprofen) 001-002/MR Date: 28 January 2016 This module reflects the scientific discussion for the approval

More information

PL 17871/0208 UKPAR TABLE OF CONTENTS

PL 17871/0208 UKPAR TABLE OF CONTENTS Fultium-D 3 3,200 IU Capsules PL 17871/0208 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 11 Summary of Product Characteristics Page 12 Patient

More information

Public Assessment Report. Decentralised Procedure. CosmoCol Half 6.9 g, powder for oral solution CosmoCol Paediatric 6.9 g, powder for oral solution

Public Assessment Report. Decentralised Procedure. CosmoCol Half 6.9 g, powder for oral solution CosmoCol Paediatric 6.9 g, powder for oral solution Public Assessment Report Decentralised Procedure CosmoCol Half 6.9 g, powder for oral solution CosmoCol Paediatric 6.9 g, powder for oral solution (Macrogol, sodium chloride, sodium hydrogen carbonate

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Linezolid Pfizer 2 mg/ml Solution for Infusion Linezolid Pfizer 100 mg/5 ml Granules for Oral Suspension Procedure No: UK/H/5515/001-003/DC UK Licence No:

More information

Memantine hydrochloride 20 mg film-coated tablets PL 17907/0291

Memantine hydrochloride 20 mg film-coated tablets PL 17907/0291 Memantine hydrochloride 20 mg film-coated tablets PL 17907/0291 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 5 Steps Taken for Assessment Page 13 Summary of Product Characteristics

More information

OMEPRAZOLE 10 MG, 20 MG AND 40 MG GASTRO-RESISTANT HARD CAPSULES. (omeprazole)

OMEPRAZOLE 10 MG, 20 MG AND 40 MG GASTRO-RESISTANT HARD CAPSULES. (omeprazole) OMEPRAZOLE 10 MG, 20 MG AND 40 MG GASTRO-RESISTANT HARD CAPSULES (omeprazole) PL 36884/0001, PL 36884/0002, PL 36884/0003, PL 36884/0004, PL 36884/0005 AND PL 36884/0006 UKPAR TABLE OF CONTENTS Lay Summary

More information

ANASTROZOLE 1 MG FILM-COATED TABLETS. (Anastrozole) PL 40378/0123 UKPAR TABLE OF CONTENTS

ANASTROZOLE 1 MG FILM-COATED TABLETS. (Anastrozole) PL 40378/0123 UKPAR TABLE OF CONTENTS ANASTROZOLE 1 MG FILM-COATED TABLETS (Anastrozole) PL 40378/0123 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of Product Characteristics

More information

Public Assessment Report

Public Assessment Report Public Assessment Report Decentralised Procedure Zoledronic Acid 4mg/5ml Concentrate for Solution for Infusion Procedure No: UK Licence No: PL 24598/0029 Noridem Enterprises Limited LAY SUMMARY On 25 January

More information

Public Assessment Report. Decentralised Procedure. PAR Bisoprolol 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg film-coated tabs

Public Assessment Report. Decentralised Procedure. PAR Bisoprolol 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg film-coated tabs PAR Bisoprolol 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg film-coated tabs Public Assessment Report Decentralised Procedure Bisoprolol 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg film-coated

More information

Aciclovir 200mg Tablets Aciclovir 400mg Tablets Aciclovir 800mg Tablets PL 29831/0517 PL 29831/0518 PL 29831/0519 UKPAR

Aciclovir 200mg Tablets Aciclovir 400mg Tablets Aciclovir 800mg Tablets PL 29831/0517 PL 29831/0518 PL 29831/0519 UKPAR Aciclovir 200mg Tablets Aciclovir 400mg Tablets Aciclovir 800mg Tablets PL 29831/0517 PL 29831/0518 PL 29831/0519 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for

More information

SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT

SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Guideline Title Specifications and Control Tests on the Finished Product Legislative basis Directive 75/318/EEC as amended Date of first adoption

More information

UKPAR Goodnight THR 00904/0003. Goodnight THR 00904/0003 UKPAR TABLE OF CONTENTS. Lay Summary Page 2. Scientific discussion Page 3

UKPAR Goodnight THR 00904/0003. Goodnight THR 00904/0003 UKPAR TABLE OF CONTENTS. Lay Summary Page 2. Scientific discussion Page 3 Goodnight THR 00904/0003 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after authorisation Page 13 Summary of Product Characteristics

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

Public Assessment Report. Decentralised Procedure. PAR Flucloxacillin 250 mg & 500 mg Capsules. Flucloxacillin 500 mg Capsules.

Public Assessment Report. Decentralised Procedure. PAR Flucloxacillin 250 mg & 500 mg Capsules. Flucloxacillin 500 mg Capsules. Public Assessment Report Decentralised Procedure Flucloxacillin 250 mg Capsules Flucloxacillin 500 mg Capsules (flucloxacillin) Procedure No: UK/H/1101/001-002/DC UK Licence No: PL 21880/0017-0018 Medreich

More information

Public Assessment Report. Decentralised Procedure. Alimemazine tartrate 7.5mg/5ml Syrup. Alimemazine tartrate 30mg/5ml Syrup

Public Assessment Report. Decentralised Procedure. Alimemazine tartrate 7.5mg/5ml Syrup. Alimemazine tartrate 30mg/5ml Syrup Public Assessment Report Decentralised Procedure Alimemazine tartrate 7.5mg/5ml Syrup Alimemazine tartrate 30mg/5ml Syrup Procedure No: UK Licence No: PL 41830/0029-0030 NRIM Limited 1 LAY SUMMARY Alimemazine

More information

Public Assessment Report Scientific discussion. Prednisolon mibe (prednisolone acetate) SE/H/1317/01/DC

Public Assessment Report Scientific discussion. Prednisolon mibe (prednisolone acetate) SE/H/1317/01/DC Public Assessment Report Scientific discussion Prednisolon mibe (prednisolone acetate) SE/H/1317/01/DC This module reflects the scientific discussion for the approval of Prednisolon mibe. The procedure

More information

Levonorgestrel/Ethinylestradiol 150/30 Microgram Coated Tablets PL 20117/0044

Levonorgestrel/Ethinylestradiol 150/30 Microgram Coated Tablets PL 20117/0044 Levonorgestrel/Ethinylestradiol 150/30 Microgram Coated Tablets PL 20117/0044 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of Product

More information

Public Assessment Report. Scientific discussion. Rivamylan 4.6 mg /24 hours and 9.5 mg /24 hours, transdermal patches.

Public Assessment Report. Scientific discussion. Rivamylan 4.6 mg /24 hours and 9.5 mg /24 hours, transdermal patches. Public Assessment Report Scientific discussion Rivamylan 4.6 mg /24 hours and 9.5 mg /24 hours, transdermal patches (rivastigmine) NL/H/2958/001-002/DC Date: 30 March 2015 This module reflects the scientific

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Linezolid 2 mg/ml solution for infusion Linezolid 600mg film coated tablets Linezolid 100mg/5ml granules for oral suspension Procedure No: UK Licence No:

More information

RILUZOLE LUPIN 50 MG FILM-COATED TABLETS PL 35507/0120 UKPAR TABLE OF CONTENTS

RILUZOLE LUPIN 50 MG FILM-COATED TABLETS PL 35507/0120 UKPAR TABLE OF CONTENTS RILUZOLE LUPIN 50 MG FILM-COATED TABLETS PL 35507/0120 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 9 Steps taken after authorisation summary

More information

Decentralised Procedure. Public Assessment Report

Decentralised Procedure. Public Assessment Report Decentralised Procedure Public Assessment Report Articainhydrochlorid mit Epinephrin Pierrel 40 mg/ml + 0.01 mg/ml Injektionslösung Articainhydrochlorid mit Epinephrin Pierrel 40 mg/ml + 0.005 mg/ml Injektionslösung

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Decentralised Procedure. Public Assessment Report. Gadojaco Handvist Gadopentetat Dimeglumin Jacobsen 500 Mikromol/ml Injektionslösung

Decentralised Procedure. Public Assessment Report. Gadojaco Handvist Gadopentetat Dimeglumin Jacobsen 500 Mikromol/ml Injektionslösung Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Gadojaco Handvist Gadopentetat Dimeglumin Jacobsen 500 Mikromol/ml Injektionslösung Gadopentetate dimeglumine

More information

Urostemol Men capsules THR 02855/0240

Urostemol Men capsules THR 02855/0240 Urostemol Men capsules THR 02855/0240 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 14 Steps taken after initial registration Page 15 Summary of

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Food-Effect Bioavailability and Fed Bioequivalence Studies U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)

More information

Public Assessment Report. Decentralised Procedure. Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution

Public Assessment Report. Decentralised Procedure. Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution Public Assessment Report Decentralised Procedure Ipravent CFC-Free Inhaler 20 micrograms per actuation pressurised inhalation, solution (ipratropium bromide monohydrate) Procedure No: UK Licence No: PL

More information

Montelukast 10mg film-coated tablets PL 17907/0474

Montelukast 10mg film-coated tablets PL 17907/0474 Montelukast 10mg film-coated tablets PL 17907/0474 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 11 Steps Taken After Initial Authorisation Page

More information

Guideline on stability testing for applications for variations to a marketing authorisation

Guideline on stability testing for applications for variations to a marketing authorisation 21 March 2014 EMA/CHMP/CVMP/QWP/441071/2011- Rev.2 Committee for Medicinal Products for Human Use (CHMP)/ Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on stability testing for applications

More information

Hypromellose Eye Drops BP 0.3% w/v PL 23097/0006

Hypromellose Eye Drops BP 0.3% w/v PL 23097/0006 Hypromellose Eye Drops BP 0.3% w/v PL 23097/0006 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 9 Summary of product characteristics Page 10 Patient

More information

PUBLIC ASSESSMENT REPORT. Decentralised Procedure DE/H/2924/001/DC. Calcium 1000 mg / Vitamin D3 880 I.U. chewable tablets

PUBLIC ASSESSMENT REPORT. Decentralised Procedure DE/H/2924/001/DC. Calcium 1000 mg / Vitamin D3 880 I.U. chewable tablets Federal Institute for Drugs and Medical Devices PUBLIC ASSESSMENT REPORT Decentralised Procedure DE/H/2924/001/DC Calcium 1000 mg / Vitamin D3 880 I.U. chewable tablets Calcium carbonate, Cholecalciferol

More information

BIOAVAILABILITY & BIOEQUIVALENCE TRIALS

BIOAVAILABILITY & BIOEQUIVALENCE TRIALS BIOAVAILABILITY & BIOEQUIVALENCE TRIALS Shubha Rani,, Ph.D. Technical Director & Head-Biometrics and Data Management Synchron Research Services Pvt. Ltd. Ahmedabad 380 054 drshubha@synchronresearch.com

More information

Bioequivalence Study Design Considerations. Dr. John Gordon

Bioequivalence Study Design Considerations. Dr. John Gordon Bioequivalence Study Design Considerations Dr. John Gordon Key Output of Programme A list of prequalified medicinal products used for treatment of HIV/AIDS, malaria, tuberculosis, influenza, and for reproductive

More information

Public Assessment Report

Public Assessment Report Public Assessment Report Decentralised Procedure Alendronic Acid and Calcium/Cholecalciferol 70+1000mg/880IU Film-coated Tablets+Effervescent Tablets Procedure No: UK Licence No: PL 04416/1162-4 Sandoz

More information

College ter Beoordeling van Geneesmiddelen (CBG) Medicines Evaluation Board (MEB) Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands

College ter Beoordeling van Geneesmiddelen (CBG) Medicines Evaluation Board (MEB) Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands MEB agency / Veterinary Medicinal Products Unit The Netherlands C B G M E B College ter Beoordeling van Geneesmiddelen (CBG) Medicines Evaluation Board (MEB) Graadt van Roggenweg 500 3531 AH Utrecht The

More information

Public Assessment Report Scientific discussion. Tostrex (Testosterone) SE/H/571/01

Public Assessment Report Scientific discussion. Tostrex (Testosterone) SE/H/571/01 Public Assessment Report Scientific discussion Tostrex (Testosterone) SE/H/571/01 This module reflects the scientific discussion for the approval of Tostrex. The procedure was finalised at 2006-04-07.

More information

Draft agreed by Pharmacokinetics Working Party January 2011. Adoption by CHMP for release for consultation 17 February 2011

Draft agreed by Pharmacokinetics Working Party January 2011. Adoption by CHMP for release for consultation 17 February 2011 17 November 2011 EMA/CHMP/600958/2010/Corr.* Committee of Medicines for Human Use (CHMP) Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of

More information

Decentralised Procedure. Public Assessment Report. Leflunomide DE/H/2609/001-002/DC. Applicants: M.R. Pharma GmbH

Decentralised Procedure. Public Assessment Report. Leflunomide DE/H/2609/001-002/DC. Applicants: M.R. Pharma GmbH Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Leflunopharm 10 mg Filmtabletten Leflunomide DE/H/2609/001-002/DC Applicants: M.R. Pharma GmbH

More information

Agencia Española de Medicamentos y Productos Sanitarios C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State)

Agencia Española de Medicamentos y Productos Sanitarios C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State) DEPARTAMENTO DE MEDICAMENTOS VETERINARIOS Medicamentos y Productos C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State) DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR

More information

Humulin (LY041001) Page 1 of 1

Humulin (LY041001) Page 1 of 1 (LY041001) These clinical study results are supplied for informational purposes only in the interests of scientific disclosure. They are not intended to substitute for the FDA-approved package insert or

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure FOSFOMYCIN 3G GRANULES FOR ORAL SOLUTION Procedure No: UK Licence No: PL 31513/0007 Temapharm Sp. z.o.o. LAY SUMMARY On 17 April 2013, Czech Republic, Estonia,

More information

Public Assessment Report. Decentralised Procedure. Omega 3-acid-ethyl esters 1000mg Soft Capsules. Omega-3-acid ethyl esters 90

Public Assessment Report. Decentralised Procedure. Omega 3-acid-ethyl esters 1000mg Soft Capsules. Omega-3-acid ethyl esters 90 Public Assessment Report Decentralised Procedure Omega 3-acid-ethyl esters 1000mg Soft Capsules Omega-3-acid ethyl esters 90 Procedure No: UK Licence No: PL 00289/1756 and PL 00289/1778-80 Teva UK Limited

More information

Volume 2B Notice to Applicants. Medicinal products for human use. Presentation and format of the dossier. Common Technical Document (CTD)

Volume 2B Notice to Applicants. Medicinal products for human use. Presentation and format of the dossier. Common Technical Document (CTD) Volume 2B Notice to Applicants Medicinal products for human use Presentation and format of the dossier Common Technical Document (CTD) Introduction Edition June 26 Module 1 Edition May 28 Module 2 Edition

More information

STREPSILS BLACKCURRANT FLAVOUR LOZENGES STREPSILS DRY & SORE THROAT BLACKCURRANT FLAVOUR LOZENGES

STREPSILS BLACKCURRANT FLAVOUR LOZENGES STREPSILS DRY & SORE THROAT BLACKCURRANT FLAVOUR LOZENGES STREPSILS BLACKCURRANT FLAVOUR LOZENGES STREPSILS DRY & SORE THROAT BLACKCURRANT FLAVOUR LOZENGES (amylmetacresol, 2,4-dichlorobenzyl alcohol, ascorbic acid and sodium ascorbate) PL 00063/0692 UKPAR TABLE

More information