Decentralised Procedure. Public Assessment Report. Celecoxib-ratiopharm / Celecoxib AbZ 100/200 mg Hartkapseln. (Celecoxib) DE/H/ / /DC
|
|
- Gregory Bradley
- 7 years ago
- Views:
Transcription
1 Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Celecoxib-ratiopharm / Celecoxib AbZ 100/200 mg Hartkapseln (Celecoxib) DE/H/ / /DC Applicant: ratiopharm GmbH / Teva Pharma B.V. Reference Member State DE The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health. 1/8 Public AR
2 TABLE OF CONTENTS I. INTRODUCTION... 4 II. EXECUTIVE SUMMARY... 4 II.1 Problem statement... 4 II.2 About the product... 4 II.3 General comments on the submitted dossier... 4 II.4 General comments on compliance with GMP, GLP, GCP and agreed ethical principles..5 III. SCIENTIFIC OVERVIEW AND DISCUSSION... 5 III.1 Quality aspects... 5 III.2 Nonclinical aspects... 6 III.3 Clinical aspects... 6 IV. BENEFIT RISK ASSESSMENT /8 Public AR
3 ADMINISTRATIVE INFORMATION Proposed name of the medicinal product in the RMS INN (or common name) of the active substance(s): Pharmaco-therapeutic group (ATC Code): Pharmaceutical form(s) and strength(s): Reference Number for the Decentralised Procedure Reference Member State: Member States concerned: Applicant (name and address) Celecoxib-ratiopharm / Celecoxib AbZ 100/200 mg Hartkapseln Celecoxib M01AH01, Non-steroidal anti-inflammatory and antirheumatic drugs, NSAIDs, Coxibs Capsule, hard ; 100 / 200 mg DE/H/ / /DC DE AT, BE, BG, CY, EL, ES, FR, HU, IS, IT, LU, NL, NO, PT, RO, SE, SK DE/H/3057/ /DC: ratiopharm GmbH Graf-Arco-Str. 3, D Ulm, Germany DE/H/3058/ /DC: Teva Pharma B.V. Computerweg 10, NL-3542DR Utrecht, The Netherlands 3/8 Public AR
4 I. INTRODUCTION Based on the review of the data on quality, safety and efficacy, the application for Celecoxibratiopharm / Celecoxib AbZ 100/200 mg Hartkapseln in the treatment of Symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, is approved. II. EXECUTIVE SUMMARY II.1 Problem statement N/A II.2 About the product Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that is a selective inhibitor of cyclooxygenase-2 (COX-2). Celecoxib capsules of 100 and 200 mg strength are approved for achieving symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis if the individual patient's overall risks are outweighed by the benefit of treatment with a selective COX-2 inhibitor. Celecoxib received approval in the European Union in December 1999 following a mutual recognition procedure with Sweden serving as the reference member state. Celecoxib was approved by the US FDA in December 1998 under priority review to relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis. Celecoxib is indicated for the symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks. Osteoarthritis The usual recommended daily dose is 200 mg taken once daily or in two divided doses. In some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered. Rheumatoid arthritis The initial recommended daily dose is 200 mg taken in two divided doses. The dose may, if needed, later be increased to 200 mg twice daily. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered. Ankylosing spondylitis The recommended daily dose is 200 mg taken once daily or in two divided doses. In a few patients, with insufficient relief from symptoms, an increased dose of 400 mg once daily or in two divided doses may increase efficacy. In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered. The maximum recommended daily dose is 400 mg for all indications. II.3 General comments on the submitted dossier The applications for Celecoxib-ratiopharm / Celecoxib AbZ 100/200 mg Hartkapseln are generic applications made according to Article 10(1) of Directive 2001/83/EC. The applicants, ratiopharm GmbH (DE/H/3057/ /DC ) and Teva Pharma B.V. (DE/H/3058/ /DC), apply through the Decentralised Procedure with Germany acting as reference member state (RMS) and AT, BE, BG, CY, EL, ES, FR, HU, IS, IT, LU, NL, NO, PT, RO, SE and SK as concerned member states (CMS). The reference medicinal product chosen for the purposes of establishing the expiry of the data protection period is Celebra 100 mg and 200 mg capsule, hard authorised in Sweden since 3 December 1999, with Pfizer AB as marketing authorisation holder. 4/8 Public AR
5 The active substance is not considered a new active substance. II.4 General comments on compliance with GMP, GLP, GCP and agreed ethical principles. GMP The RMS has been assured that acceptable standards of GMP are in place for these product types at all sites responsible for the manufacture and assembly of this product. For manufacturing sites within the Community, the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those sites. Additionally GMP certificates issued by the competent authorities for the manufacturers of the finished drug product following inspections have been provided. For the active substance Celecoxib a certificate of GMP compliance of a manufacturer, issued by the competent authority of Australia, following an inspection, dated on October 2010 is presented. Updated QP statements covering all mentioned manufacturing sites for the drug substance itself and for the two intermediates used for the manufacture of Celecoxib have been provided. For manufacturing sites outside the Community, the RMS has accepted copies of current GMP Certificates of satisfactory inspection summary reports, issued by the inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those non- Community sites. GCP The applicant declares that the submitted bioequivalence studies (DEV2407-5CEL09 and DEV2407-6CEL09) have been performed in accordance with GCP. III. III.1 SCIENTIFIC OVERVIEW AND DISCUSSION Quality aspects Drug substance The chemical-pharmaceutical documentation and Expert Report in relation to Celecoxib-ratiopharm / Celecoxib AbZ 100/200 mg Hartkapseln are of sufficient quality in view of the present European regulatory requirements. The drug substance of the present generic product is Celecoxib, which is described in the European Pharmacopoeia. In the meantime a monograph for Celecoxib has been included in the European Pharmacopoeia 7.5 Supplement, which will be officially implemented on 1 st of July Because of the adaptation to the new Ph. Eur. Monograph for Celecoxib the ASM. updated the ASMF and the applicant updated the relevant parts of Module 3. Details on characteristics, manufacturing process, impurity profile, specifications, analytical procedures and validations of drug substances are presented in an Active Substance Master File. The drug substance manufacturer has submitted the complete ASMF (open part and restricted part) in its current version / amendment to the regulatory authority along with a letter of access to allow the applicant to refer to their ASMF. The control tests and specifications for drug substance are adequately drawn up. Stability studies have been performed with the drug substance. No significant changes in any parameters were observed. The proposed retest period of 5 years is justified. 5/8 Public AR
6 Drug Product The development of the products Celecoxib-ratiopharm / Celecoxib AbZ 100/200 mg Hartkapseln has been described, the choice of excipients is justified and their functions explained. Dissolution profiles of the two strengths (two capsules of 100 mg compared with one capsule of 200 mg) at different ph values (ph 1.2, ph 4.5, ph 6.8 and ph 12) under conditions of the validated testing method described in the quality part have been provided. The similarity of the dissolution profiles of both strengths could be shown under these conditions. The biowaiver for the 100 mg strength is accepted. The product specifications cover appropriate parameters for this dosage form. Validations of the analytical methods have been presented. Batch analysis has been performed on 6 production batches (3 batches for the 100 mg capsules and 3 batches for the 200 mg capsules). The batch analysis results show that the finished products meet the specifications proposed. 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 shelf-life of 36 months with no storage restrictions is accepted for Celecoxib-ratiopharm / Celecoxib AbZ 100/200 mg Hartkapseln, stored in Alu-Alu blisters and HDPE bottles. The shelf-life of 36 months with the storage condition Do not store above 30 C is accepted for Celecoxibratiopharm / Celecoxib AbZ 100/200 mg Hartkapseln, stored in PVC-PVdC -Alu blisters. III.2 Nonclinical aspects Pharmacodynamics, Pharmacokinetics, Toxicology Nonclinical pharmacodynamic, pharmacokinetic and toxicological properties of celecoxib are well known. As celecoxib is a widely used, well-known active substance, no further nonclinical studies are required and the applicant provides none. Overview based on literature review is, thus, appropriate. The submitted nonclinical overview on the nonclinical pharmacology, pharmacokinetics and toxicology of celecoxib is adequate. From a nonclinical point of view, marketing authorization is recommended. Environmental Risk Assessment A specific environmenta risk assessment was not provided. The applicant states that, based on the assumption that this generic product is intended to substitute for other identical products on the market, the approval of the referred product should not result in an increase of the total quantity of celecoxib released into the environment. The applicant concludes that, therefore it should not result in increase of risk to the environment during storage, distribution, use and disposal. Taking into account that celecoxib will be used as a prescription-only medicinal product, this conclusion is accepted. III.3 Clinical aspects Bioequivalence studies As these are medicinal products with a systemic effect, there is the need of appropriate bioequivalence studies to justify efficacy. In order to demonstrate bioequivalence between the Applicant s formulation and the reference product, Celebrex, the applicant has submitted as report one pilot (study no DEV2407-5CEL09) and and one pivotal bioequivalence study (DEV2407-6CEL09) for the CELECOXIB 200 mg HARD CAPSULES. Based on the results of the pilot bioequivalence study (DEV2407-5CEL09), the applicant has provided the rationale for selecting a test product as a suitable formulation for use in the pivotal bioequivalence study versus the reference product. 6/8 Public AR
7 Based on the presented pivotal bioequivalence study (DEV2407-6CEL09), the CELECOXIB 200 mg HARD CAPSULES are considered bioequivalent with the reference product Celebrex 200 mg hard capsules, since the estimated 90% confidence intervalls for AUC and Cmax are within the preset acceptance range of 80% - 125%. Table Test vs reference product comparison in study DEV2407-6CEL09 The safety profile of the CELECOXIB 200 mg HARD CAPSULES, as observed in the pivotal bioequivalence study, was acceptable, no unexpected safety issues were identified. Biowaiver for the 100 mg strength The applicant has provided justification for a biowaiver for the 100 mg strength in accordance with the Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1/Corr), stating that the CELECOXIB HARD CAPSULES, 100 and 200 mg are manufactured by the same manufacturer and process; the drug input has been shown to be linear over the therapeutic dose range; the qualitative composition of the different strengths is the same; the composition of the strengths are quantitatively proportional, i.e. the ratio between the amount of each excipient to the amount of active substance(s) is the same for all strengths; the dissolution profiles are similar under identical conditions for the additional strengths and the strength of the batch used in the bioequivalence study. Dissolution profiles of the two strengths (100 mg and 200 mg) at different ph values (ph 1.2, ph 4.5, ph 6.8 and ph 12) under conditions of the validated testing method described in the quality part have been provided. The similarity of the dissolution profiles of both strengths could be shown under these conditions. The addition of the surfactant in the chosen amount for the dissolution method has been also justified. Therefore the biowaiver for the 100 mg strength is accepted. Pharmacodynamics The pharmacodynamic profile of celecoxib is established and sufficiently characterized in literature. Literature references are reviewed in the clinical overview. No new data are requested. Clinical efficacy and safety No clinical efficacy or safety study reports are provided. Literature references to support clinical efficacy and safety of celecoxib in respective indications are reviewed in the clinical overview. The clinical data for the claimed indications are sufficiently discussed by the applicant within the clinical overview. The efficacy and safety of celecoxib is well established. The efficacy and safety characteristics of the innovator have been reassessed repeatedly after the first marketing authorisation and at last within a variation procedure in 2010 (SE/H/C/198/59). The efficacy and safety are adequately reflected in the currently approved innovator SmPC. No new safety concern was detected in this review. Overview based on literature review is appropriate. 7/8 Public AR
8 User testing Overall, the test methodology follows the guidelines of the European Commission (Guideline on the readability of the label and package leaflet of medicinal products for human use, Revision January 2009; Update of Directive 2001/83/EC as amended by Directive 2004/27/EC / Guidance concerning consultations with target patient groups for the packet leaflet, May 2006). Both the first and the second test round met the success criteria of 90% of the participants are able to find the requested information in the PIL, and of those, 90% being able to give the correct answer, to indicate that they can understand and properly interpret the information. The general impression of the PL (Content, language and layout) was mostly positive. In conclusion, the user test is considered acceptable. Description of Pharmacovigilance System Details have been provided of the Teva pharmacovigilance system (Version 10 dated January 2011). A statement signed by the applicant and the qualified person for pharmacovigilance, indicating that the applicant has the services of a qualified person responsible for pharmacovigilance and the necessary means for the notification of any adverse reaction occurring either in the Community or in a third country has been provided. The Pharmacovigilance system as described by the applicant fulfils the requirements as described in Volume 9A of the Rules Governing Medicinal Products in the European Union 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. Risk Management Plan The applicant has presented an application for waiver of EU Risk Management Plan dated 15 June The applicant states that an RMP is not required for this generic application as no safety concerns requiring additional risk minimisation activities have been identified with the active substance celecoxib. IV. BENEFIT RISK ASSESSMENT The application contains an adequate review of published nonclinical and clinical data. With regard to the efficacy and safety analysis, the characteristics of the innovator have been reassessed repeatedly after the first marketing authorisation and at last actualised within a finalised variation procedure in 2010 (SE/H/C/198/59). No new safety concern was detected in this review. Based on the submitted pivotal bioequivalence study, the CELECOXIB 200 mg HARD CAPSULES are considered bioequivalent with the reference product Celebrex 200 mg hard capsules. Also, the biowaiver claimed for the 100 mg strength is accepted. The application is approved. 8/8 Public AR
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 informationDecentralised 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 informationPublic 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 informationPublic 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 informationPublic 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 informationPL 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 informationDecentralised Procedure. Public Assessment Report. Leflunomide DE/H/2609/001-002/DC. Applicants: M.R. Pharma GmbH
Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Leflunopharm 10 mg Filmtabletten Leflunomide DE/H/2609/001-002/DC Applicants: M.R. Pharma GmbH
More informationPublic 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 informationDecentralised Procedure. Public Assessment Report. Gadojaco Handvist Gadopentetat Dimeglumin Jacobsen 500 Mikromol/ml Injektionslösung
Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Gadojaco Handvist Gadopentetat Dimeglumin Jacobsen 500 Mikromol/ml Injektionslösung Gadopentetate dimeglumine
More informationDonepezil 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 informationLacidipine 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 informationPublic 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 informationMemantine 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 informationHYDROCORTISONE 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 informationIbuprofen 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 informationPublic 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 informationPublic 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 informationSTREPSILS 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 informationCETIRIZINE 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 informationMIGRAINE 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 informationPublic 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 informationPublic 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 informationPublic 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 informationFexofenadine 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 informationPublic 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 informationPublic 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 informationPUBLIC ASSESSMENT REPORT. Decentralised Procedure DE/H/2924/001/DC. Calcium 1000 mg / Vitamin D3 880 I.U. chewable tablets
Federal Institute for Drugs and Medical Devices PUBLIC ASSESSMENT REPORT Decentralised Procedure DE/H/2924/001/DC Calcium 1000 mg / Vitamin D3 880 I.U. chewable tablets Calcium carbonate, Cholecalciferol
More informationRILUZOLE 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 informationOmeprazole 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 informationPublic 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 informationDecentralised Procedure. Public Assessment Report
Decentralised Procedure Public Assessment Report Articainhydrochlorid mit Epinephrin Pierrel 40 mg/ml + 0.01 mg/ml Injektionslösung Articainhydrochlorid mit Epinephrin Pierrel 40 mg/ml + 0.005 mg/ml Injektionslösung
More informationANASTROZOLE 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 informationAciclovir 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 informationLevonorgestrel/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 informationTRAMADOL 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 informationPublic 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 informationCollege ter Beoordeling van Geneesmiddelen (CBG) Medicines Evaluation Board (MEB) Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands
MEB agency / Veterinary Medicinal Products Unit The Netherlands C B G M E B College ter Beoordeling van Geneesmiddelen (CBG) Medicines Evaluation Board (MEB) Graadt van Roggenweg 500 3531 AH Utrecht The
More informationPublic 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 informationPublic 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 informationPublic 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 informationMontelukast 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 informationLEMSIP 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 informationPublic 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 informationPublic 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 informationCollege 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 informationPublic 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 informationMACROGOL 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 informationGuideline on dossier requirements for Type IA and IB notifications
Guideline on dossier requirements for Type IA and IB notifications In accordance with Regulation (EC) No 726/2004 and Directives 2001/83/EC and 2001/82/EC, a common approach to the procedures for variations
More informationPublic 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 informationPublic 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 informationSummary 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 informationPublic 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 informationPublic 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 informationSummary 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 informationPublic 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 informationAgencia Española de Medicamentos y Productos Sanitarios C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State)
DEPARTAMENTO DE MEDICAMENTOS VETERINARIOS Medicamentos y Productos C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State) DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR
More informationPublic 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 informationPublic 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 informationPublic 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 informationPublic 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 informationCETRABEN 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 informationPublic 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 informationA critical review of the current. marketing authorisation transfer procedure. in Europe
A critical review of the current marketing authorisation transfer procedure in Europe Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen
More informationBeclometasone 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 informationPublic 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 informationPublic 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 informationFRENCH 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 informationPublic 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 informationPUBLIC ASSESSMENT REPORT Scientific Discussion. Perindopril arginine Amlodipine FR/H/325-326-327/01-04/DC. Applicant: Servier
Direction de l Evaluation des Médicaments et des Produits Biologiques PUBLIC ASSESSMENT REPORT Scientific Discussion COVERAM PERINDOPRIL ARGININE - AMLODIPINE SERVIER PERINDOPRIL ARGININE AMLODIPINE BIOPHARMA
More informationPublic Assessment Report. Decentralised Procedure. Omeprazole 10mg Gastro-resistant Capsules, hard. Omeprazole 20mg Gastro-resistant Capsules, hard
Public Assessment Report Decentralised Procedure Omeprazole 10mg Gastro-resistant Capsules, hard Omeprazole 20mg Gastro-resistant Capsules, hard Omeprazole 40mg Gastro-resistant Capsules, hard (UK/H/4423/001-003/DC)
More informationPublic 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 informationPublic 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 informationAscorbic 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 informationPublic 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 informationPublic 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 informationNEUROTONE 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 informationHypromellose 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 informationOMEPRAZOLE 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 informationMRP & DCP step by steb instructions how to apply and how the procedures are conducted
MRP & DCP step by steb instructions how to apply and how the procedures are conducted 06 May 2013 Dubrovnik, Croatia Dr. Peter Bachmann Head of Unit Coordination Group European and International Affairs
More informationPublic 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 informationEUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL. Brussels, ENTR/CT 1. Revision 1
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market : management & legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations Brussels, ENTR/CT 1 Revision
More informationPublic 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 informationPublic Assessment Report. Scientific discussion. Ramipril Teva 1.25 mg, 2.5 mg, 5 mg and 10 mg tablets Ramipril DK/H/2130/001-004/DC.
Public Assessment Report Scientific discussion Ramipril Teva 1.25 mg, 2.5 mg, 5 mg and 10 mg tablets Ramipril DK/H/2130/001-004/DC 3 April 2014 Tis module reflects te scientific discussion for te approval
More informationPublic 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 informationAgencia Española de Medicamentos y Productos Sanitarios C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State)
DEPARTAMENTO DE MEDICAMENTOS VETERINARIOS Medicamentos y Productos C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State) DECENTRALISED PROCEDURE [DRAFT] PUBLICLY AVAILABLE ASSESSMENT REPORT
More informationUrostemol 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 informationPublic Assessment Report. Scientific discussion. Apotel 10 mg/ml, solution for infusion. (paracetamol) NL/H/2857/001/DC
Public Assessment Report Scientific discussion Apotel 10 mg/ml, solution for infusion (paracetamol) NL/H/2857/001/DC Date: 16 December 2014 This module reflects the scientific discussion for the approval
More informationVolume 2B Notice to Applicants. Medicinal products for human use. Presentation and format of the dossier. Common Technical Document (CTD)
Volume 2B Notice to Applicants Medicinal products for human use Presentation and format of the dossier Common Technical Document (CTD) Introduction Edition June 26 Module 1 Edition May 28 Module 2 Edition
More informationPublic 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 informationCMD(v)/GUI/014. GUIDANCE for The Processing of Generic Applications Through MRP / DCP
EMEA/CMDv/262452/2008 GUIDANCE Edition number : 00 Edition date: 19 June 2008 Implementation date : 04 July 2008 CMD(v) Secretariat: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74
More informationRegulations for Handling Samples and Laboratory Testing from R&D through Phase III Clinical Trials
Regulations for Handling Samples and Laboratory Testing from R&D through Phase III Clinical Trials Ron Hinkel, Director Quality Systems BioReliance Inc. Patti Rossman, President Globiox Purpose Keep pace
More informationPublic 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 informationSPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT
SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Guideline Title Specifications and Control Tests on the Finished Product Legislative basis Directive 75/318/EEC as amended Date of first adoption
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products- authorisations, European Medicines Agency Brussels, EudraLex The Rules Governing Medicinal
More informationAnnex 6. Guidance on variations to a prequalified product dossier. Preface
Annex 6 Guidance on variations to a prequalified product dossier Preface This guidance document was technically and structurally inspired by the Guideline on dossier requirements for type IA and IB notifi
More informationGuideline on stability testing for applications for variations to a marketing authorisation
21 March 2014 EMA/CHMP/CVMP/QWP/441071/2011- Rev.2 Committee for Medicinal Products for Human Use (CHMP)/ Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on stability testing for applications
More informationPublic Assessment Report Scientific discussion. Tostrex (Testosterone) SE/H/571/01
Public Assessment Report Scientific discussion Tostrex (Testosterone) SE/H/571/01 This module reflects the scientific discussion for the approval of Tostrex. The procedure was finalised at 2006-04-07.
More informationPublic 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 informationPublic Assessment Report. Decentralised Procedure
Public Assessment Report Decentralised Procedure Opticrom Allergy Single Dose 2% w/v Eye Drops, Solution (sodium cromoglicate) Procedure No: UK Licence No: PL 04425/0688 Aventis Pharma Limited (T/A Sanofi-aventis
More informationPublic 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