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DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION PL 25258/0107 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Steps taken after authorisation – summary Page 11 Summary of Product Characteristics Page 12 Patient Information Leaflet Page 13 Labelling Page 14 MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution -1- PL 25258/0107 DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION PL 25258/0107 LAY SUMMARY The Medicines and Healthcare products Regulatory Agency granted Glenmark Generics (Europe) Limited, a Marketing Authorisation for the medicinal product Dorzolamide 20 mg/mL Eye Drops, Solution (PL 25258/0107) on 30 August 2012. The product is a prescription-only medicine (POM). Dorzolamide 20 mg/mL Eye Drops, Solution contains the active ingredient, dorzolamide, a sulphonamide-related compound. Dorzolamide is an ophthalmic carbonic anhydrase inhibitor which reduces high pressure in the eye. It is indicated in the treatment of elevated intra-ocular pressure in conditions susch ocular hypertension and glaucoma (open-angle glaucoma, pseudo-exfoliative glaucoma). Dorzolamide can be used alone or in addition to other medicines which lower the pressure in the eye (so called beta-blockers). No new or unexpected safety concerns arose from this application and it was, therefore, judged that the benefits of taking Dorzolamide 20 mg/mL Eye Drops, Solution (PL 25258/0107) outweigh the risks; hence a Marketing Authorisation has been granted. MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution -2- PL 25258/0107 DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION PL 25258/0107 SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 4 Pharmaceutical assessment Page 5 Non-Clinical assessment Page 7 Clinical assessment Page 8 Overall conclusions and risk benefit assessment Page 9 MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution -3- PL 25258/0107 INTRODUCTION Based on the review of the data on quality, safety and efficacy, the MHRA granted Gelnmark Generics (Europe) Limited, a Marketing Authorisation for the medicinal product, Dorzolamide 20 mg/mL Eye Drops, Solution (PL 25258/0107), on 30 August 2012. The product is a prescription-only medicine (POM). This is a simple, abridged, ‘informed consent’ application submitted according to Article 10c of EC Directive 2001/83 (as amended), cross-referencing the Marketing Authorisation for Dorzolamide 20mg/ml Eye drops, solution (PL 31225/0005) held by Pharmathen International Ltd since 13 August 2010; which in turn refers to the innovator product TRUSOPT® 2% Eye Drops, solution (PL00025/0323) authorised to Merck Sharp & Dohme Limited since 9 January 1995. The innovator product has been authorised in the EEA for over 10 years. No new data were submitted nor was it necessary for this simple application as the data are identical to that of the previously granted cross-reference product. A Public Assessment Report has been generated for the cross-reference product Dorzolamide 20mg/ml Eye drops, solution (PL 31225/0005) authorised to Pharmathen International Ltd. MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution -4- PL 25258/0107 PHARMACEUTICAL ASSESSMENT LICENCE NO: PL 25258/0107 PROPRIETARY NAME: Dorzolamide 20 mg/mL Eye Drops, Solution ACTIVE: Dorzolamide COMPANY NAME: Glenmark Generics (Europe) Limited E.C. ARTICLE: Article 10c of Directive 2001/83/EC LEGAL STATUS: POM 1. INTRODUCTION This is a simple, informed consent application for Dorzolamide 20 mg/mL Eye Drops, Solution under Article 10c of Directive 2001/83/EC. The proposed Marketing Authorisation Holder is Glenmark Generics (Europe) Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex HA3 0BU, UK. The application cross-refers to Dorzolamide 20mg/ml Eye drops, solution (PL 31225/0005) held by Pharmathen International Ltd since 13 August 2010. The current application is considered valid. 2. MARKETING AUTHORISATION APPLICATION FORM 2.1 Name The proposed name of the product is Dorzolamide 20 mg/mL Eye Drops, Solution. The product has been named in line with current requirements. 2.2 Strength, pharmaceutical form, route of administration, container and pack sizes Each mL contains 20 mg dorzolamide (as dorzolamide hydrochloride).The medicinal product is licensed for marketed in medium density polyethylene bottles with a sealed dropper tip and a two-piece cap assembly which are packed with the Patient Information Leaflet (PIL) in a cardboard outer carton, in pack sizes of 1 x 5mL, 3 x 5 mL and 6 x 5mL bottkes. The container closures system and pack sizes are identical to those for the reference product. The approved shelf-life (2 years) is satisfactory. The storage conditions for this product are, “Keep the bottle in the outer carton in order to protect from light” and “Store below 30oC” which is identical to the details registered for the cross-reference product. 2.3 Legal status This product is a prescription-only medicine (POM). 2.4 Marketing authorisation holder/Contact Persons/Company The proposed Marketing Authorisation Holder is Glenmark Generics (Europe) Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex HA3 0BU, UK. The Quality Person (QP) responsible for pharmacovigilance is stated and their curriculum vita has been included. 2.5 Manufacturers The proposed manufacturing sites are consistent with those registered for the cross-reference product and evidence of GMP compliance has been provided. MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution -5- PL 25258/0107 2.6 Qualitative and quantitative composition The proposed composition is consistent with the details registered for the cross-reference product. 2.7 Manufacturing process The proposed manufacturing process is consistent with the details registered for the cross-reference product and the maximum batch size is stated. 2.8 Finished product/shelf-life specification The proposed finished product specification is in-line with the details registered for the crossreference product. 2.9 Drug substance specification The proposed drug substance specification is consistent with the details registered for the crossreference product. 2.10 TSE Compliance No material used in the manufacturing of this medicinal product is derived from animal or human origin or sourced from genticially modified organisms. This is consistent with the cross-reference product. 3. EXPERT REPORT A satisfactory quality overall summary has been prepared by an appropriately qualified expert. The CV of the expert was provided. 4. PRODUCT NAME & APPEARANCE See 2.1 for details of the proposed product name. The licenced eye drops solution is an isotonic, buffered, slightly viscous, clear, colourless aqueous solution and is identical to that of the crossreference product. 5. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) The approved SmPC is consistent with the details registered for the cross-reference product. 6. PATIENT INFORMATION LEAFLET (PIL)/CARTON PIL The PIL is satisfactory and in line with the approved SmPC and has been prepared in the usertested format. The applicant has submitted results of PIL user testing for the reference product Dorzolamide 20mg/ml Eye drops, solution (PL 31225/0005) marketed by Pharmathen. A bridging statement has been included to the proposed product; as the text and layout are identical this can be accepted. Labelling Mock-up of the labelling has been provided and is satisfactory. The approved artwork is comparable to the artwork registered for the cross-reference product and complies with statutory requirements. 7. CONCLUSIONS The data submitted with is application is acceptable. A Marketing Authorisation was, therefore, granted. MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution -6- PL 25258/0107 NON-CLINICAL ASSESSMENT This is a simple, abridged, ‘informed consent’ application made under Article 10c of EC Directive 2001/83 (as amended). This application is identical to the reference product, Dorzolamide 20mg/ml Eye drops, solution (PL 31225/0005) authorised to Pharmathen International Ltd on 13 August 2010 in the UK, therefore, no new non-clinical data has been supplied with this application and none are required. A non-clinical overview report has been written by a suitably qualified person and is satisfactory. The CV of the non-clinical expert has been supplied. The marketing authorisation holder has provided adequate justification for not submitting an Environment Risk Assessment (ERA). As this application is identical to already authorised reference product, it is not expected that the environmental exposure to dorzolamide will increase following the marketing approval of the proposed product. MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution -7- PL 25258/0107 CLINICAL ASSESSMENT This is a simple, abridged, ‘informed consent’ application made under Article 10c of EC Directive 2001/83 (as amended), cross-referring to Dorzolamide 20mg/ml Eye drops, solution (PL 31225/0005) authorised to Pharmathen International Ltd on 13 August 2010 in the UK. No new clinical data has been supplied with this application and none are required. A clinical overview has been written by a suitably qualified person and is satisfactory. The CV of the clinical expert has been supplied. The marketing authorisation holder (MAH) has provided adequate justification for not submitting a Risk Management Plan (RMP). As this application is identical to already authorised reference product, for which safety concerns requiring additional risk minimisation have not been identified, a risk minimisation system is not considered necessary. The reference product has been in use for many years and the safety profile of the active is well-established. The MAH has provided a suitable pharmacovigilance system that fulfils the requirements and provides adequate evidence that the MAH 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. MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution -8- PL 25258/0107 OVERALL CONCLUSION AND RISK BENEFIT ASSESSMENT QUALITY The data for this application is consistent with those previously assessed for the cross-reference product and as such has been judged to be satisfactory. NON-CLINICAL No new non-clinical data were submitted and none are required for an application of this type. EFFICACY This application is considered identical to the previously granted licence for Dorzolamide 20mg/ml Eye drops, solution (PL 31225/0005) authorised to Pharmathen International Ltd on 13 August 2010 in the UK. The current application is considered valid. No new or unexpected safety concerns arise from this application. PRODUCT LITERATURE The approved SmPC, PIL and labelling are satisfactory, and consistent with those for the crossreference product. The applicant has submitted results of PIL user testing for the reference product Dorzolamide 20mg/ml Eye drops, solution (PL 31225/0005) marketed by Pharmathen. A bridging statement has been included to the proposed product; as the text and layout are identical this can be accepted. Mock-ups of the labeling have been provided and are satisfactory. The labeling artwork complies with statutory requirements. RISK BENEFIT ASSESSMENT The quality of the product is acceptable and no new non-clinical or clinical safety concerns have been identified. The applicant’s product is identical to the cross-reference product. The benefit; risk ratio is, therefore, considered to be positive. MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution -9- PL 25258/0107 DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION PL 25258/0107 STEPS TAKEN FOR ASSESMENT 1 The MHRA received the marketing authorisation application on 22 August 2011. 2 Following standard checks and communication with the applicant the MHRA considered the application valid on 15 September 2011. 3 Following assessment of the application the MHRA requested further information relating to the quality dossier on 14 December 2011 and 28 February 2012. 4 The applicant responded to the MHRA’s requests, providing further information on 16 January 2012 and 12 March 2012. 5 The application was determined on 30 August 2012. MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution - 10 - PL 25258/0107 DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION PL 25258/0107 STEPS TAKEN AFTER ASSESSMENT Date submitted Application type Scope Outcome MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution - 11 - PL 25258/0107 DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION PL 25258/0107 SUMMARY OF PRODUCT CHARACTERISTICS In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) for products granted Marketing Authorisations at a national level are available on the MHRA website. MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution - 12 - PL 25258/0107 DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION PL 25258/0107 PATIENT INFORMATION LEAFLET In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) for products granted Marketing Authorisations at a national level are available on the MHRA website. MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution - 13 - PL 25258/0107 DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION PL 25258/0107 LABELLING MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution - 14 - PL 25258/0107 MHRA-UKPAR – Dorzolamide 20mg/mL Eye Drops, Solution - 15 - PL 25258/0107