Summary Public Assessment Report. Generics

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Summary Public Assessment Report. Generics"

Transcription

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

2 Summary Public Assessment Report Generics Amoxicillin Trihydrate + Potassium Clavulanate, Film-coated tablet, 875 mg mg. This is a summary of the public assessment report (PAR) for. It explains how was assessed and its authorisation recommended as well as its conditions of use. It is not intended to provide practical advice on how to use. For practical information about using, patients should read the package leaflet or contact their doctor or pharmacist. What is and what is it used for? is a generic medicine. This means that Amoxicilina + Ácido Clavulânico Alter is similar to a reference medicine already authorised in the European Union (EU) called Augmentin Duo, 875mg + 125mg, film-coated tablets. is used in adults and children to treat the following infections: - middle ear and sinus infections - respiratory tract infections - urinary tract infections - skin and soft tissue infections including dental infections - bone and joint infections. How does work? is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to the group of penicillins that can sometimes be made inactive. The other active component (clavulanic acid) stops this from happening. How is used? The pharmaceutical form of is film-coated tablet and the route of administration is oral. Please read section 3 of the PL for detailed information on dosing recommendations, the route of administration, and the duration of treatment. The medicine can only be obtained with a prescription. What benefits of have been shown in studies? Because is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Augmentin Duo, 875mg + 125mg, film-coated tablets. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. 2/7

3 What are the possible side effects of Ácido Clavulânico Alter? Because Ácido Clavulânico Alter is a generic medicine and is bioequivalent to the reference medicine, its benefits and possible side effects are taken as being the same as the reference medicine. For the full list of restrictions, see the package leaflet. Why is Ácido Clavulânico Alter approved? It was concluded that, in accordance with EU requirements, Ácido Clavulânico Alter has been shown to have comparable quality and to be bioequivalent/be comparable to Augmentin Duo, 875mg + 125mg, film-coated tablets. Therefore, INFARMED I.P. decided that, as for Augmentin Duo, 875mg + 125mg, film-coated tablets, the benefits are greater than its risk and recommended that it can be approved for use. What measures are being taken to ensure the safe and effective use of Ácido Clavulânico Alter? A risk management plan has been developed to ensure that Ácido Clavulânico Alter is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ácido Clavulânico Alter, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously as well. Other information about Ácido Clavulânico Alter The marketing authorisation for Ácido Clavulânico Alter was granted on The full PAR for Ácido Clavulânico Alter can be found on the website For more information about treatment with read the package leaflet or contact your doctor or pharmacist. This summary was last updated in MM-YYYY. 3/7

4 Public Assessment Report Scientific discussion 875 mg mg, Film-coated tablets (Amoxicillin Trihydrate + Potassium Clavulanate) This module reflects the scientific discussion for the approval of Amoxicilina + Ácido Clavulânico Alter. The procedure was finalised at For information on changes after this date please refer to the module Update. 4/7

5 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have agreed in granting a marketing authorisation for, 875 mg mg, film-coated tablets, from Alter, S.A. The product is indicated for the treatment of the following infections in adults and children: - Acute bacterial sinusitis (adequately diagnosed) - Acute otitis media - Acute exacerbations of chronic bronchitis (adequately diagnosed) - Community acquired pneumonia - Cystitis - Pyelonephritis - Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with - spreading cellulitis. - Bone and joint infections, in particular osteomyelitis. A comprehensive description of the indications and posology is given in the SmPC. The originator product is Augmentin Duo, 875mg + 125mg, film-coated tablets by Glaxosmithkline Produtos Farmacêuticos, Lda, registered since The marketing authorisation has been granted pursuant to Article 10.1 of Directive 2001/83/EC. II. QUALITY ASPECTS II.1 Introduction, 875 mg mg, film-coated tablets, are white to off-white film coated capsule shaped tablets debossed with RX509 on one side and score line on the other. Each tablet contains mg Amoxicillin trihydrate equivalent to 875 mg Amoxicillin and mg of Potassium clavulanate equivalent to 125 mg Clavulanic acid. tablets are available in PVC/PVdC/Alu blister pack in pouch (Polyester film/aluminium foil/polyester film/polyethylene) with 1g sachet containing molecular sieve. The excipients are Cellulose microcrystalline, Sodium starch glycolate, Silica colloidal anhydrous, Povidone, Eudragit E100, Magnesium stearate, Hypromellose, Titanium dioxide (E171), Macrogol 400, Talc. II.2 Drug Substance The chemical-pharmaceutical documentation and Expert Report in relation amoxicillin trihydrate and to potassium clavulanate are of sufficient quality in view of the present European regulatory requirements. II.3 Medicinal Product The documentation provided complies with relevant EU guidelines and directives. Manufacture is performed in accordance with cgmp and consistency in quality and homogeneity is demonstrated. 5/7

6 The finished product specification is based on relevant development and stability studies. The development of the product has been described, the choice of excipients is justified and their functions explained. Appropriate validation data have been provided for the analytical methods. Batch analyses data support the proposed finished product specification. The conditions used in the stability studies are according to the ICH stability guideline. The control tests and specifications for drug product are adequately drawn up. The proposed shelf-life of 24 months for the drug product, stored below 25ºC, in the original package to protect from light, is considered acceptable. III. NON-CLINICAL ASPECTS Pharmacodynamic, pharmacokinetic and toxicological properties of amoxicillin and clavulanic acid are well known. As amoxicillin and clavulanic acid are widely used, well-known active substances, the applicant has not provided additional studies and further studies are not required. An overview based on literature review is, thus, appropriate. The non-clinical overview on the pre-clinical pharmacology, pharmacokinetics and toxicology is adequate. Environmental Risk Assessment (ERA) An Environmental Risk Assessment has not been performed as the product is intended for generic substitution. A disposal advice has been added to the SmPC. IV. CLINICAL ASPECTS One bioequivalence study in single dose fed conditions for, 875 mg + 125mg, Film-coated Tablets, was included in the present application. Augmentan Filmtabletten 875/125 mg manufactured by SmithKline Beecham plc. T/A Smithkline Beecham Pharmaceuticals, was the reference product. The bioequivalence has been proved. Pharmacovigilance System Summary According with the new legislation for Pharmacovigilance applied in the European Union (EU), the Applicant has submitted the Pharmacovigilance System Summary. Risk Management Plan This application is not an application for a new active substance, or for a similar biological medicinal product. It is an application for generic medicinal product where a safety concern requiring additional risk minimisation activities has not been identified with the reference medicinal product. This MAA is for an essentially similar Medicinal Product with the same Summary of the Product Characteristics (SmPC) as the innovator s Product. In view of the above an EU-RMP is not being submitted with this Marketing Authorisation Application. This was considered acceptable by the RMS. V. USER CONSULTATION A user consultation with target patient groups on the package information leaflet (PIL) has been performed on the basis of a bridging report, which has been found acceptable. 6/7

7 VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Based on the review of the data on quality, safety and efficacy, the RMS considers that the application for, 875 mg mg, film-coated tablets is approvable. 7/7

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

Summary Public Assessment Report. Generics. Escitalopram Ratiopharm PT/H/0846/01-04/DC. Date:

Summary Public Assessment Report. Generics. Escitalopram Ratiopharm PT/H/0846/01-04/DC. Date: Summary Public Assessment Report Generics 5 mg, 10 mg, 15 mg, 20 mg, Orodisperdible tablets (escitalopram, oxalate) PT/H/0846/001-004/DC Date: 07-11-2014 1/7 Summary Public Assessment Report Generics Escitalopram,

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. 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. 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

Public Assessment Report Public Assessment Report Sodium Chloride 1 mmol/ml Oral Solution (sodium chloride) UK Licence No: PL 20346/0008 Viridian Pharma Ltd LAY SUMMARY Sodium Chloride 1 mmol/ml Oral Solution (sodium chloride)

More information

DEXAMETHASONE 0.5 MG TABLETS PL 17507/0052 TABLE OF CONTENTS

DEXAMETHASONE 0.5 MG TABLETS PL 17507/0052 TABLE OF CONTENTS DEXAMETHASONE 0.5 MG TABLETS PL 17507/0052 TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 11 Steps taken after authorisation summary Page 12 Summary of

More information

Paracetamol 1000 mg Effervescent Tablets PL 31388/0005

Paracetamol 1000 mg Effervescent Tablets PL 31388/0005 Paracetamol 1000 mg Effervescent Tablets PL 31388/0005 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 12 Summary of Product Characteristics Page

More information

Public Assessment Report Scientific discussion. Levetiracetam Ranbaxy (levetiracetam) SE/H/1004/01-04/DC

Public Assessment Report Scientific discussion. Levetiracetam Ranbaxy (levetiracetam) SE/H/1004/01-04/DC Public Assessment Report Scientific discussion Levetiracetam Ranbaxy (levetiracetam) SE/H/1004/01-04/DC This module reflects the scientific discussion for the approval of Levetiracetam Ranbaxy. The procedure

More information

Sterilised Water for Injections PL 08801/0057 UKPAR

Sterilised Water for Injections PL 08801/0057 UKPAR Sterilised Water for Injections PL 08801/0057 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

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. 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

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

Summary Public Assessment Report. non-generics. (Acetylcysteine) PT/H/873/001/MR

Summary Public Assessment Report. non-generics. (Acetylcysteine) PT/H/873/001/MR Summary Public Assessment Report non-generics Acetilcisteína Friulchem (Acetylcysteine) Summary PAR non-generics 1/8 Acetilcisteína Friulchem Acetilcisteína Friulchem Acetylcysteine 1200 mg effervescent

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. 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. 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

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

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

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

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

InVita D3 25,000 IU oral solution PL 24837/0039

InVita D3 25,000 IU oral solution PL 24837/0039 InVita D3 25,000 IU oral solution PL 24837/0039 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 5 Steps taken for assessment Page 12 Summary of Product Characteristics Page 13 Patient

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

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

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

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 UKPAR. Clobetasol Propionate 0.05% w/w Cream Clobetasol Propionate 0.05% w/w Ointment. (Clobetasol propionate).

Public Assessment Report UKPAR. Clobetasol Propionate 0.05% w/w Cream Clobetasol Propionate 0.05% w/w Ointment. (Clobetasol propionate). Public Assessment Report UKPAR Clobetasol Propionate 0.05% w/w Cream Clobetasol Propionate 0.05% w/w Ointment (Clobetasol propionate). UK Licence No: PL 17507/0235-0236 Auden Mckenzie (Pharma Division)

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

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 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

PAROXETINE 20 MG TABLETS PAROXETINE 30 MG TABLETS PL 40378/ UKPAR TABLE OF CONTENTS

PAROXETINE 20 MG TABLETS PAROXETINE 30 MG TABLETS PL 40378/ UKPAR TABLE OF CONTENTS PAROXETINE 20 MG TABLETS PAROXETINE 30 MG TABLETS PL 40378/0101-0102 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 11 Summary of Product Characteristics

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 UKPAR. Nurofen Joint & Back Pain Relief 5% Gel Nurofen Muscular Pain Relief Gel Pharmacy Only. Ibuprofen

Public Assessment Report UKPAR. Nurofen Joint & Back Pain Relief 5% Gel Nurofen Muscular Pain Relief Gel Pharmacy Only. Ibuprofen Public Assessment Report UKPAR Nurofen Joint & Back Pain Relief 5% Gel Ibuprofen UK Licence No: Reckitt Benckiser Healthcare (UK) Limited 1 LAY SUMMARY Nurofen Joint & Back Pain Relief 5% Gel (ibuprofen)

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. 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

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

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

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. 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 UKPAR. Fluoride 2800 ppm Toothpaste Fluoride 5000 ppm Toothpaste. (Sodium fluoride) UK Licence No: PL 20117/

Public Assessment Report UKPAR. Fluoride 2800 ppm Toothpaste Fluoride 5000 ppm Toothpaste. (Sodium fluoride) UK Licence No: PL 20117/ Public Assessment Report UKPAR Fluoride 2800 ppm Toothpaste Fluoride 5000 ppm Toothpaste (Sodium fluoride) UK Licence No: PL 20117/0239-0240 Morningside Healthcare Limited 1 LAY SUMMARY Fluoride 2800 ppm

More information

Nicotine 1 mg Compressed Lozenge Nicotine 2 mg Compressed Lozenge PL 00030/0463-0468

Nicotine 1 mg Compressed Lozenge Nicotine 2 mg Compressed Lozenge PL 00030/0463-0468 Nicotine 1 mg Compressed Lozenge Nicotine 2 mg Compressed Lozenge PL 00030/0463-0468 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 5 Steps Taken for Assessment Page 13 Summary of

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

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

(paracetamol and caffeine) PL 00071/0659

(paracetamol and caffeine) PL 00071/0659 Paracetamol and Caffeine 500 mg/65 mg Tablets (paracetamol and caffeine) PL 00071/0659 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 14 Steps taken

More information

MACROGOL COMPOUND ORAL POWDER (sodium chloride, sodium hydrogen carbonate, potassium chloride, macrogol 3350) PL 33579/0001 UKPAR TABLE OF CONTENTS

MACROGOL COMPOUND ORAL POWDER (sodium chloride, sodium hydrogen carbonate, potassium chloride, macrogol 3350) PL 33579/0001 UKPAR TABLE OF CONTENTS MACROGOL COMPOUND ORAL POWDER (sodium chloride, sodium hydrogen carbonate, potassium chloride, macrogol 3350) PL 33579/0001 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps

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

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

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

Public Assessment Report UKPAR. Galpharm Nicotine Replace 2 mg and 4 mg Gum. (Nicotine resinate) UK Licence No: PL 12063/

Public Assessment Report UKPAR. Galpharm Nicotine Replace 2 mg and 4 mg Gum. (Nicotine resinate) UK Licence No: PL 12063/ Public Assessment Report UKPAR Galpharm Nicotine Replace 2 mg and 4 mg Gum (Nicotine resinate) UK Licence No: PL 12063/0133-0134 Wrafton Laboratories Limited 1 LAY SUMMARY Galpharm Nicotine Replace 2 mg

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

Irish Medicines Board

Irish Medicines Board Irish Medicines Board (Reference Member State) MUTUAL RECOGNITION PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT Clindaseptin 150 mg Capsules for Dogs CMD(v)/TEM/003-00

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

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. Euplix 20 mg/20 drops (33.1 mg/ml) oral drops, solution. Paroxetine (as paroxetine mesilate)

Public Assessment Report. Scientific discussion. Euplix 20 mg/20 drops (33.1 mg/ml) oral drops, solution. Paroxetine (as paroxetine mesilate) Public Assessment Report Scientific discussion Euplix 20 mg/20 drops (33.1 mg/ml) oral drops, solution Paroxetine (as paroxetine mesilate) DK/H/0240/002/MR This module reflects the scientific discussion

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. 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

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. 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

LEMSIP MAX DAY & NIGHT COLD & FLU RELIEF CAPSULES. (paracetamol, caffeine and phenylephrine hydrochloride)

LEMSIP MAX DAY & NIGHT COLD & FLU RELIEF CAPSULES. (paracetamol, caffeine and phenylephrine hydrochloride) LEMSIP MAX DAY & NIGHT COLD & FLU RELIEF CAPSULES (paracetamol, caffeine and phenylephrine hydrochloride) PL 00063/0529 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 5 Summary of

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

Beclometasone Dipropionate 50 micrograms per spray Aqueous Nasal Spray PL 16431/0178

Beclometasone Dipropionate 50 micrograms per spray Aqueous Nasal Spray PL 16431/0178 Beclometasone Dipropionate 50 micrograms per spray Aqueous Nasal Spray PL 16431/0178 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 5 Steps Taken for Assessment Page 11 Steps Taken

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

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. Scientific discussion. Imipenem/Cilastatine Stravencon 250 mg/250 mg and 500 mg/500 mg powder for solution for infusion

Public Assessment Report. Scientific discussion. Imipenem/Cilastatine Stravencon 250 mg/250 mg and 500 mg/500 mg powder for solution for infusion Public Assessment Report Scientific discussion Imipenem/Cilastatine Stravencon 250 mg/250 mg and 500 mg/500 mg powder for solution for infusion (imipenem monohydrate/cilastatin sodium) NL/H/3075/001-002/DC

More information

Urostemol capsules THR 02855/0239

Urostemol capsules THR 02855/0239 Urostemol capsules THR 02855/0239 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after initial registration Page 13 Summary of Product

More information

POTASSIUM NITRATE AND SODIUM FLUORIDE 5/0.315% W/W TOOTHPASTE PL 00036/ UKPAR TABLE OF CONTENTS

POTASSIUM NITRATE AND SODIUM FLUORIDE 5/0.315% W/W TOOTHPASTE PL 00036/ UKPAR TABLE OF CONTENTS POTASSIUM NITRATE AND SODIUM FLUORIDE 5/0.315% W/W TOOTHPASTE PL 00036/0307-9 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. 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

EMCREM CREAM (White soft paraffin 15.0% w/w, Liquid paraffin 6.0% w/w) PL 19876/0013

EMCREM CREAM (White soft paraffin 15.0% w/w, Liquid paraffin 6.0% w/w) PL 19876/0013 EMCREM CREAM (White soft paraffin 15.0% w/w, Liquid paraffin 6.0% w/w) PL 19876/0013 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Steps taken

More information

Decentralised Procedure. Public Assessment Report. Celecoxib-ratiopharm / Celecoxib AbZ 100/200 mg Hartkapseln. (Celecoxib) DE/H/ / /DC

Decentralised Procedure. Public Assessment Report. Celecoxib-ratiopharm / Celecoxib AbZ 100/200 mg Hartkapseln. (Celecoxib) DE/H/ / /DC Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Celecoxib-ratiopharm / Celecoxib AbZ 100/200 mg Hartkapseln (Celecoxib) DE/H/3057-3058/001-002/DC Applicant:

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

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

PUBLIC ASSESSMENT REPORT Scientific Discussion. ASPROFLASH 500mg, Coated Tablets. Acetylsalicylic acid FR/H/0482/001/DC

PUBLIC ASSESSMENT REPORT Scientific Discussion. ASPROFLASH 500mg, Coated Tablets. Acetylsalicylic acid FR/H/0482/001/DC Direction NEURHO /DP3 Neurologie-Psychiatrie-Antalgie-Rhumatologie- Pneumologie-ORL-Ophtalmologie-Stups et psychotropes PUBLIC ASSESSMENT REPORT Scientific Discussion ASPROFLASH 500mg, Coated Tablets Acetylsalicylic

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. Pemetrexed 25 mg/ml Concentrate for Solution for Infusion. (pemetrexed ditrometamol)

Public Assessment Report. Decentralised Procedure. Pemetrexed 25 mg/ml Concentrate for Solution for Infusion. (pemetrexed ditrometamol) Public Assessment Report Decentralised Procedure Pemetrexed 25 mg/ml Concentrate for Solution for Infusion (pemetrexed ditrometamol) Procedure No: UK Licence No: PL 24668/0187 Caduceus Pharma Ltd 1 LAY

More information

Package leaflet: Information for the patient. Co-amoxiclav 500 mg/125 mg Film-coated Tablets 500 mg/125 mg film-coated tablets

Package leaflet: Information for the patient. Co-amoxiclav 500 mg/125 mg Film-coated Tablets 500 mg/125 mg film-coated tablets Package leaflet: Information for the patient Co-amoxiclav 500 mg/125 mg Film-coated Tablets 500 mg/125 mg film-coated tablets Amoxicillin Clavulanic acid Read all of this leaflet carefully before you start

More information

LOSARTAN POTASSIUM 12.5, 25MG, 50MG & 100MG FILM- COATED TABLETS PL 14017/ UKPAR TABLE OF CONTENTS

LOSARTAN POTASSIUM 12.5, 25MG, 50MG & 100MG FILM- COATED TABLETS PL 14017/ UKPAR TABLE OF CONTENTS LOSARTAN POTASSIUM 12.5, 25MG, 50MG & 100MG FILM- COATED TABLETS PL 14017/0140-3 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 5 Steps taken for assessment Page 16 Summary of Product

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

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

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. 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 Scientific discussion. Hydrokortison CCS (hydrocortisone) SE/H/321/01/E01

Public Assessment Report Scientific discussion. Hydrokortison CCS (hydrocortisone) SE/H/321/01/E01 Public Assessment Report Scientific discussion Hydrokortison CCS (hydrocortisone) SE/H/321/01/E01 This module reflects the scientific discussion for the approval of Hydrokortison CCS. The procedure was

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

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

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

Boots Pharmaceuticals Bruise Relief Arnica cream THR 01175/0398 UKPAR TABLE OF CONTENTS. Lay summary Page 2. Scientific discussion Page 3

Boots Pharmaceuticals Bruise Relief Arnica cream THR 01175/0398 UKPAR TABLE OF CONTENTS. Lay summary Page 2. Scientific discussion Page 3 Boots Pharmaceuticals Bruise Relief Arnica cream UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Summary of Product Characteristics Page 11 Patient

More information

Dechra Veterinary Products Limited (A business unit of Dechra Pharmaceuticals PLC) Sansaw Business Park Hadnall, Shrewsbury Shropshire SY4 4AS

Dechra Veterinary Products Limited (A business unit of Dechra Pharmaceuticals PLC) Sansaw Business Park Hadnall, Shrewsbury Shropshire SY4 4AS Dechra Veterinary Products Limited (A business unit of Dechra Pharmaceuticals PLC) Sansaw Business Park Hadnall, Shrewsbury Shropshire SY4 4AS Tel: 01939 211200 Fax: 01939 211201 Email: info.uk@dechra.com

More information

Health Products Regulatory Authority IPAR IRISH MEDICINES BOARD PUBLIC ASSESSMENT REPORT FOR A MEDICINAL PRODUCT FOR HUMAN USE. Scientific discussion

Health Products Regulatory Authority IPAR IRISH MEDICINES BOARD PUBLIC ASSESSMENT REPORT FOR A MEDICINAL PRODUCT FOR HUMAN USE. Scientific discussion IPAR IRISH MEDICINES BOARD PUBLIC ASSESSMENT REPORT FOR A MEDICINAL PRODUCT FOR HUMAN USE Scientific discussion Meropenem 500 mg and 1 g, Powder for Solution for Injection or Infusion (Meropenem Trihydrate)

More information

Public Assessment Report. Scientific discussion

Public Assessment Report. Scientific discussion Public Assessment Report Scientific discussion Dropodex 0.1% w/v eye drops, solution (Dexamethasone sodium phosphate) MT/H/0157/001/DC Date: 3 rd May, 2013 This module reflects the scientific discussion

More information

1.3.1.3 PACKAGE LEAFLET

1.3.1.3 PACKAGE LEAFLET Sandoz Business use only Page 1 of 8 1.3.1.3 PACKAGE LEAFLET Sandoz Business use only Page 2 of 8 Package leaflet: Information for the patient Cefuhexal 250 mg film-coated tablets Cefuhexal 500 mg film-coated

More information

CETIRIZINE DIHYDROCHLORIDE 10MG FILM-COATED TABLETS PL 40378/0140-1 UKPAR TABLE OF CONTENTS

CETIRIZINE DIHYDROCHLORIDE 10MG FILM-COATED TABLETS PL 40378/0140-1 UKPAR TABLE OF CONTENTS CETIRIZINE DIHYDROCHLORIDE 10MG FILM-COATED TABLETS PL 40378/0140-1 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 8 Steps taken after authorisation

More information

CANESTEN DUAL ACTION 1% W/W CREAM (PL 00010/0645) UKPAR TABLE OF CONTENTS

CANESTEN DUAL ACTION 1% W/W CREAM (PL 00010/0645) UKPAR TABLE OF CONTENTS CANESTEN DUAL ACTION 1% W/W CREAM (PL 00010/0645) UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after authorisation summary Page

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 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. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure TEMOZOLOMIDE RELIANCE 20 MG HARD CAPSULES TEMOZOLOMIDE RELIANCE 100 MG HARD CAPSULES TEMOZOLOMIDE RELIANCE 140 MG HARD CAPSULES TEMOZOLOMIDE RELIANCE 180

More information

Public Assessment Report. Scientific discussion. Pantoprazol Beximco 20 mg and 40 mg, gastro-resistant tablets. (pantoprazole) NL/H/2751/001-002/DC

Public Assessment Report. Scientific discussion. Pantoprazol Beximco 20 mg and 40 mg, gastro-resistant tablets. (pantoprazole) NL/H/2751/001-002/DC 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

Holland & Barrett Dandelion Capsules. GNC Live Well Dandelion Capsules. Lifecycle Dandelion Capsules. Nature s Garden Dandelion Capsules

Holland & Barrett Dandelion Capsules. GNC Live Well Dandelion Capsules. Lifecycle Dandelion Capsules. Nature s Garden Dandelion Capsules Holland & Barrett Dandelion Capsules GNC Live Well Dandelion Capsules Lifecycle Dandelion Capsules Nature s Garden Dandelion Capsules Nature s Bounty Dandelion Capsules UKPAR TABLE OF CONTENTS Lay summary

More information

Decentralised Procedure. Public Assessment Report. Pramipexol-ratiopharm 0,088/0,18/0,35/0,7 mg Tabletten. Pramipexole dihydrochloride monohydrate

Decentralised Procedure. Public Assessment Report. Pramipexol-ratiopharm 0,088/0,18/0,35/0,7 mg Tabletten. Pramipexole dihydrochloride monohydrate Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Pramipexol-ratiopharm 0,088/0,18/0,35/0,7 mg Tabletten Pramipexole dihydrochloride monohydrate DE/H/1258/001-004/DC

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. 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. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Thorens 10 000 I.U. /ml oral drops, solution Thorens 25 000 I.U. /2.5 ml oral solution Deltius 10 000 I.U. /ml oral drops, solution Deltius 25 000 I.U.

More information