Download DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION PL 25258/0107

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
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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.
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DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION
PL 25258/0107
STEPS TAKEN AFTER ASSESSMENT
Date
submitted
Application
type
Scope
Outcome
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DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION
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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.
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DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION
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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.
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DORZOLAMIDE 20 MG/ML EYE DROPS SOLUTION
PL 25258/0107
LABELLING
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PL 25258/0107