Public Assessment Report. Decentralised Procedure

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Public Assessment Report. Decentralised Procedure"

Transcription

1 Public Assessment Report Decentralised Procedure FOSFOMYCIN 3G GRANULES FOR ORAL SOLUTION Procedure No: UK Licence No: PL 31513/0007 Temapharm Sp. z.o.o.

2 LAY SUMMARY On 17 April 2013, Czech Republic, Estonia, Hungary, Latvia, Poland, Slovak Republic and the UK agreed to grant a Marketing Authorisation to Temapharm Sp. z.o.o. for the medicinal product Fosfomycin 3g Granules for Oral Solution (PL 31513/0007; ). The licence was granted via the Decentralised Procedure (DCP), with the UK as Reference Member State (RMS). After the national phase, a Marketing Authorisation was granted in the UK on 31 May This is a prescription-only medicine that is used to treat or prevent infections of the bladder. Fosfomycin belongs to a group of medicines known as antibiotics. It works by killing bacteria, which can cause infections. No new or unexpected safety concerns arose from this application and it was therefore judged that the benefits of taking Fosfomycin 3g Granules for Oral Solution outweigh the risks; hence, a Marketing Authorisation was granted. 2

3 TABLE OF CONTENTS Module 1: Information about initial procedure Page 3 Module 2: Summary of Product Characteristics Page 4 Module 3: Patient Information Leaflets Page 22 Module 4: Labelling Page 24 Module 5: Scientific Discussion Page 28 1 Introduction 2 Quality aspects 3 Non-clinical aspects 4 Clinical aspects 5 Overall conclusions Module 6 Steps taken after initial procedure 3

4 Module 1 Information About Initial Procedure Product Name Fosfomycin 3g Granules for Oral Solution Type of Application Generic, Article 10(1) Active Substances Form Strength Fosfomycin trometamol Granules for Oral Solution 3g MA Holder Temapharm Sp. z o.o., ul. Żwirki i Wigury 81, Warszawa Reference Member State (RMS) Concerned Member States (CMS) Procedure Number UK Czech Republic, Estonia, Hungary, Latvia, Poland and Slovak Republic Timetable Day April

5 Module 2 Summary of Product Characteristics The current approved UK version of the Summary of Product Characteristics (SmPC) for this product is available on the MHRA website. 5

6 Module 3 Patient Information Leaflet The current approved UK version of the Patient Information Leaflet (PIL) for this product is available on the MHRA website. 6

7 Module 4 Labelling 7

8 8

9 9

10 10

11 Module 5 Scientific discussion during initial procedure I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the member states considered that the application for Fosfomycin 3g Granules for Oral Solution (PL 31513/0007; ) could be approved. This application was submitted via the Decentralised Procedure, with the UK as Reference Member State (RMS), and Czech Republic, Estonia, Hungary, Latvia, Poland and Slovak Republic as Concerned Member States (CMS). This is a prescription-only medicine for the treatment of acute uncomplicated lower urinary tract infections in adults, caused by pathogens sensitive to fosfomycin. It is also indicated for periprocedural prophylaxis in diagnostic and surgical transurethral procedures. This was an application made under the Decentralised Procedure (DCP), according to Article 10(1) of Directive 2001/83/EC, as amended, a generic application claiming essential similarity to the originator product Monuril adulti 3g, granulato per soluzione orale, which was initially granted to Zambon France in July Fosfomycin exerts its antibacterial effect by inhibition of cell wall synthesis. Through covalent binding it inhibits the enzyme UPD-N-acetylglucosamine enolpyruvyl transferase, which catalyses the formation of the cell wall building block acetyl- uraminic acid, an early step in wall synthesis. Uptake into the bacterial cell occurs either via the L-α-glycerol phosphate transport system or, if glucose-6-phosphate is present, the hexose phosphate transport system. Fosfomycin is active against a range of Gram-positive and Gram-negative bacteria including some β-lactamase producing strains and those bacteria frequently isolated from urinary tract infection, such as Escherichia coli, Proteus spp., Klebsiella spp., Staphylococcus spp., and Enterococci. No new non-clinical or clinical data were provided with this application, which is satisfactory for this type of application. The RMS has been assured that acceptable standards of Good Manufacturing Practice are in place for these product types at all sites responsible for the manufacture, assembly and batch release of this product. The RMS and CMS considered that the application could be approved with the end of procedure (Day 210) on 17 April After a subsequent national phase, the licence was granted in the UK on 31 May

12 II. ABOUT THE PRODUCT Name of the product in the Reference Member State Name(s) of the active substance(s) (INN) Pharmacotherapeutic classification (ATC code) Pharmaceutical form and strength(s) Reference numbers for the Mutual Recognition Procedure Reference Member State Concerned Member States Fosfomycin 3g Granules for Oral Solution Fosfomycin trometamol Other antibacterials (J01XX01) 3g Granules for Oral Solution United Kingdom Czech Republic, Estonia, Hungary, Latvia, Poland and Slovak Republic Marketing Authorisation Number(s) PL 31513/0007 Name and address of the authorisation holder Temapharm Sp. z o.o., ul. Żwirki i Wigury 81, Warszawa 12

13 III SCIENTIFIC OVERVIEW AND DISCUSSION III.1 QUALITY ASPECTS S. Active substance Fosfomycin trometamol rinn: Fosfomycin trometamol Chemical name: 1,3-Dihydroxy-2-(hydroxymethyl)propan-2-aminium-(2R,3S)-(3- methyloxiran-2-yl) phosphonate Structure: Molecular formula: C 7 H 18 NO 7 P Molecular weight: Appearance: A white or almost white powder Solubility: Very soluble in water, slightly soluble in alcohol and in methanol, practically insoluble in acetone Fosfomycin trometamol is the subject of a European Pharmacopoeia monograph. Synthesis of the drug substance from the designated starting materials has been adequately described and appropriate in-process controls and intermediate specifications are applied. Satisfactory specification tests are in place for all starting materials and reagents and these are supported by relevant Certificates of Analysis. Appropriate proof-of-structure data have been supplied for the active substance. All potential known impurities have been identified and characterised. An appropriate specification is provided for the active substance. Analytical methods have been appropriately validated and are satisfactory for ensuring compliance with the relevant specifications. Satisfactory Certificates of Analysis have been provided for all working standards. Batch analysis data are provided and comply with the proposed specification. Suitable specifications have been provided for all packaging used. The primary packaging has been shown to comply with current guidelines concerning contact with food. Appropriate stability data have been generated supporting a suitable retest period when stored in the proposed packaging. P. Medicinal Product Other Ingredients Other ingredients consist of the pharmaceutical excipients, namely saccharine sodium, sucrose, calcium hydroxide and orange flavour (consisting of maltodextrin, dextrose monohydrate, acacia (E414), anhydrous citric acid (E330), butylhydroxyanisole (E320)). All excipients comply with their respective European Pharmacopoeia monograph, with the exception of the orange flavour, which complies with a suitable in-house specification. Suitable batch analysis data have been provided for all excipients, showing compliance with their respective specifications. None of the excipients are sourced from animal or human origin. No genetically modified organisms (GMO) have been used in the preparation of this product. 13

14 Pharmaceutical Development The objective of the development programme was to formulate a globally acceptable, stable product containing fosfomycin trometamol that could be considered a generic medicinal product of the reference product Monuril adulti 3g, granulato per soluzione orale (Zambon, France). A satisfactory account of the pharmaceutical development has been provided. Physico-chemical characteristics between this product and the reference product, including impurirty profiles and assay, confirm that the Manufacturing Process Satisfactory batch formulae have been provided for the manufacture of the finished product. The manufacturing process has been validated using six pilot-scale batches and has shown satisfactory results. The marketing authorisation holder has committed to completing validation studies for the first three commercial-scale batches produced post authorisation. Finished Product Specification The finished product specification proposed is acceptable. Test methods have been described and have been adequately validated. Batch data have been provided and comply with the release specifications. Certificates of Analysis have been provided for all working standards used. Container-Closure System The finished product is packaged in paper/low-density polyethylene/aluminium sachets, which are packed into cartons in pack sizes of one or two sachets containing 8g of product (which contain 3g of fosfomycin). The marketing authorisation holder has stated that not all pack sizes are intended for marketing. They have committed to providing the relevant licensing authority with the mock-ups for those pack sizes that will be marketed in that country. Satisfactory specifications and Certificates of Analysis have been provided for all packaging components. All primary packaging complies with the current European regulations concerning materials in contact with food. Stability of the product Stability studies were performed in accordance with current guidelines on batches of finished product packed in the packaging proposed for marketing. The data from these studies support a shelf-life of 3 years for the unopened sachets, with no specific storage conditions. After reconstitution the reconstituted solution should be used immediately. Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labels The SmPC, PIL and labels are pharmaceutically acceptable. A package leaflet has been submitted to the MHRA along with results of consultations with target patient groups ( user testing ), in accordance with Article 59 of Council Directive 2001/83/EC, as amended. The results indicate that the package leaflet is well-structured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that it contains. Marketing Authorisation Application (MAA) form The MAA form is pharmaceutically satisfactory. 14

15 Quality Overall Summary (Expert report) The pharmaceutical expert report has been written by an appropriately qualified person and is a suitable summary of the pharmaceutical dossier. Conclusion The grant of a Marketing Authorisation is recommended. III.2 NON-CLINICAL ASPECTS This application for a generic medicinal product claims essential similarity to Monuril adulti 3g, granulato per soluzione orale (Zambon, France), which has been licensed within the EEA for over 10 years. No new non-clinical data have been supplied with this application and none are required for an application of this type. No environmental risk assessment has been provided with this application. As this product is intended for generic substitution with products that are already marketed, no increase in environmental burden is anticipated. There are no objections to the approval of this product from a non-clinical viewpoint. III.3 CLINICAL ASPECTS CLINICAL PHARMACOLOGY No new data have been submitted for this application and none are required for an application of this type. EFFICACY No new data have been provided and none are required. SAFETY No new data have been provided and none are required. EXPERT REPORT A clinical expert report has been written by a suitably qualified person and is satisfactory. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) This is consistent with the SmPC for the reference product and is satisfactory. PATIENT INFORMATION LEAFLET (PIL) This is consistent with that for the reference product and is satisfactory. LABELLING These are satisfactory PHARMACOVIGILANCE SYSTEM AND RISK MANAGEMENT PLAN The Pharmacovigilance System, as described by the applicant, fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance, and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. Suitable justification has been provided for not submitting a risk management plan for this product. 15

16 APPLICATION FORM (MAA) This is satisfactory. MEDICAL CONCLUSION The grant of a marketing authorisation is recommended for this application. IV OVERALL CONCLUSION AND BENEFIT-RISK ASSESSMENT QUALITY The important quality characteristics of Fosfomycin 3g Granules for Oral Solution are well-defined and controlled. The specifications and batch analytical results indicate consistency from batch to batch. There are no outstanding quality issues that would have a negative impact on the benefit/risk balance. Bioequivalence between this and the reference product has been shown by comparison of the physico-chemical characteristics of the two products. NON-CLINICAL No new non-clinical data were submitted and none are required for an application of this type. EFFICACY No new data have been submitted No new or unexpected safety concerns arose from this application. The SmPC, PIL and labelling are satisfactory and consistent with that for the reference product. BENEFIT/RISK ASSESSMENT The quality of the products is acceptable and no new non-clinical or clinical safety concerns have been identified. The bioequivalence study supports the claim that the applicant s products and the innovator products are interchangeable. Extensive clinical experience with fosfomycin trometamol is considered to have demonstrated the therapeutic value of the compound. The benefit/risk is, therefore, considered to be positive. 16

17 Module 6 STEPS TAKEN AFTER INITIAL PROCEDURE - SUMMARY Date submitted Application type Scope Outcome 17

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

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

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

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. 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. 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

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

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

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

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. 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

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

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. 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

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

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

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

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

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

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

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. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure TRIAMCINOLONE HEXACETONIDE 20 MG/ML SUSPENSION FOR INJECTION (triamcinolone hexacetonide) Procedure No: UK Licence No: PL 17509/0061 Intrapharm Laboratories

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

NUTRYELT, concentrate for solution for infusion

NUTRYELT, concentrate for solution for infusion NUTRYELT, concentrate for solution for infusion Public Assessment Report Decentralised Procedure NUTRYELT, concentrate for solution for infusion (zinc gluconate, copper gluconate, manganese gluconate,

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

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 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. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE HYDROCHLORIDE 500 MG/200 MG/10 MG POWDER FOR ORAL SOLUTION UK Licence No: PL 12063/0118 WRAFTON LABORATORIES

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

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

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

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

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. 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

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

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 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

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

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

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

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. 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. 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 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

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. 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

CETRABEN ORIGINAL EMOLLIENT CREAM (PL 06831/0262) UKPAR TABLE OF CONTENTS

CETRABEN ORIGINAL EMOLLIENT CREAM (PL 06831/0262) UKPAR TABLE OF CONTENTS CETRABEN ORIGINAL EMOLLIENT CREAM (PL 06831/0262) 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. Mometasone furoate 50 micrograms/actuation nasal spray, suspension

Public Assessment Report. Decentralised Procedure. Mometasone furoate 50 micrograms/actuation nasal spray, suspension Public Assessment Report Decentralised Procedure Mometasone furoate 50 micrograms/actuation nasal spray, suspension (Mometasone furoate monohydrate) UK/H/5471/01/DC UK licence no: PL 36390/0157 Cipla (EU)

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. 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

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. 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

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

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 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

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

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. 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

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. 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

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

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

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 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

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 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

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

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

Public Assessment Report

Public Assessment Report Public Assessment Report SoLo Prep PL 11847/0013 MHRA: PAR SoLo Prep PL 11847/0013 1 SOLO PREP PL 11847/0013 UKPAR TABLE OF CONTENTS Page Lay Summary 3 Scientific discussion 4 Steps taken for assessment

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. (Budesonide) PL 17901/0254. AstraZeneca UK Ltd

Public Assessment Report. (Budesonide) PL 17901/0254. AstraZeneca UK Ltd Public Assessment Report Rhinocort Hay Fever 64 micrograms, Nasal Spray (Budesonide) PL 17901/0254 AstraZeneca UK Ltd 1 LAY SUMMARY Rhinocort Hay Fever 64 micrograms, Nasal Spray (Budesonide) This is a

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

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure MANEO 100 MG, 150 MG AND 200 MG PROLONGED-RELEASE TABLETS TRAMADOL HYDROCHLORIDE UK/H/4160/001-003/DC UK Licence No: PL 17871/0104-6 JENSON PHARMACEUTICAL

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

DEXTROMETHORPHAN HYDROBROMIDE 10MG/5ML ORAL SOLUTION PL 17907/0314

DEXTROMETHORPHAN HYDROBROMIDE 10MG/5ML ORAL SOLUTION PL 17907/0314 DEXTROMETHORPHAN HYDROBROMIDE 10MG/5ML ORAL SOLUTION PL 17907/0314 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Summary of Product Characteristics

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. 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

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

(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

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 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

College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board. Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands

College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board. Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands College ter Beoordeling van Geneesmiddelen / Medicines Evaluation Board Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY

More information

Marketing Authorisation Variations - Supplementary Guidance

Marketing Authorisation Variations - Supplementary Guidance Marketing Authorisation Variations - Supplementary Guidance The following includes specific guidance in relation to some common scenarios which are presented as variations and as appropriate these should

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

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

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

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

GAVISCON ADVANCE MINT CHEWABLE TABLETS PL 00063/0613 UKPAR TABLE OF CONTENTS

GAVISCON ADVANCE MINT CHEWABLE TABLETS PL 00063/0613 UKPAR TABLE OF CONTENTS GAVISCON ADVANCE MINT CHEWABLE TABLETS PL 00063/0613 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of Product Characteristics Page 12

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure CALCIUM 500 MG EFFERVESCENT TABLETS UK Licence No: PL 20075/0134 ACCORD HEALTHCARE LIMITED LAY SUMMARY On 1 st November 2011, the UK granted Accord Healthcare

More information

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

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

More information

Weleda Hayfever Relief Oromucosal Spray NR 00298/0275 UKPAR

Weleda Hayfever Relief Oromucosal Spray NR 00298/0275 UKPAR Weleda Hayfever Relief Oromucosal Spray NR 00298/0275 UKPAR TABLE OF CONTENTS Lay summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 14 Summary of Product Characteristics Page

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 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

Guideline on similar biological medicinal products

Guideline on similar biological medicinal products 23 October 2014 CHMP/437/04 Rev 1 Committee for Medicinal Products for Human Use (CHMP) Draft agreed by Biosimilar Medicinal Products Working Party and Biologics Working Party March 2013 Adopted by CHMP

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

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

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