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Relonchem Hayfever and Allergy 10 Mg Tablets Pl 20395/0088 Ukpar Table

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Relonchem Hayfever and Allergy 10 Mg Tablets Pl 20395/0088 Ukpar Table RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Steps taken after authorisation – summary Page 12 Summary of Product Characteristics Page 13 Patient Information Leaflet Page 17 Labelling Page 19 MHRA-UKPAR – RelonChem Hayfever and Allergy 10 mg Tablet PL 20395/0088 - 1 - RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 LAY SUMMARY The Medicines and Healthcare products Regulatory Agency granted Relonchem Limited, a Marketing Authorisation for the medicinal product RelonChem Hayfever and Allergy 10 mg Tablets (PL 20395/0088) on 3 April 2012. The product is a general sales list (GSL) medicine and is available to the general public without prescription. RelonChem Hayfever and Allergy 10 mg Tablets contains the active ingredient, loratadine and belongs to a group of medicines called antihistamines. These medicines act to relieve the symptoms of allergies. It can be used to relieve the symptoms of sneezing, runny and itchy nose and eye irritation and other allergies such as pet and dust allergies. It can also be used to treat raised symptoms of urticaria which is often known as hives and nettle rash. No new or unexpected safety concerns arose from this application and it was, therefore, judged that the benefits of taking RelonChem Hayfever and Allergy 10 mg Tablets (PL 20395/0088) outweigh the risks; hence a Marketing Authorisation has been granted. MHRA-UKPAR – RelonChem Hayfever and Allergy 10 mg Tablet PL 20395/0088 - 2 - RELONCHEM HAYFEVER AND ALLERGY 10 MG TABLETS PL 20395/0088 SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 4 Pharmaceutical assessment Page 5 Non-Clinical assessment Page 8 Clinical assessment Page 9 Overall conclusions and risk benefit assessment Page 10 MHRA-UKPAR – RelonChem Hayfever and Allergy 10 mg Tablet PL 20395/0088 - 3 - INTRODUCTION Based on the review of the data on quality, safety and efficacy, the MHRA granted Relonchem Limited, a Marketing Authorisation for the medicinal product, RelonChem Hayfever and Allergy 10 mg Tablets (PL 20395/0088), on 3 April 2012. The product is a general sales list (GSL) medicine and is available to the general public without prescription. 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 Loratidine 10 mg Tablets (PL 17743/0006) authorised to Medis-Danmark A/S authorised on 22 August 2002; the licence subsequently underwent a Change of Ownership on 27 March 2009 and is currently authorised to Relonchem Limited. The reference 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. As the cross-reference product was granted prior to the introduction of current legislation, no Public Assessment Report (PAR) has been generated for it. MHRA-UKPAR – RelonChem Hayfever and Allergy 10 mg Tablet PL 20395/0088 - 4 - PHARMACEUTICAL ASSESSMENT LICENCE NO: PL 20395/0088 PROPRIETARY NAME: RelonChem Hayfever and Allergy 10 mg Tablets ACTIVE: Loratadine COMPANY NAME: Relonchem Limited E.C. ARTICLE: Article 10c of Directive 2001/83/EC LEGAL STATUS: GSL 1. INTRODUCTION This is a simple, informed consent application for RelonChem Hayfever and Allergy 10 mg Tablets under Article 10c of Directive 2001/83/EC. The proposed Marketing Authorisation Holder is Relonchem Limited, 27 Old Gloucester Street, London, WC1 3XX, UK. The application cross-refers to Loratadine 10 mg Tablets (PL 17734/0006) authorised to Medis- Danmark A/S since 22 August 2002. The licence subsequently underwent a Change of Ownership on 27 March 2009 and is licenced to Relonchem Limited (PL 20395/0072). The current application is considered valid. 2. MARKETING AUTHORISATION APPLICATION FORM 2.1 Name The proposed name of the product is RelonChem Hayfeverr and Allergy 10 mg Tablets. The product has been named in line with current requirements. 2.2 Strength, pharmaceutical form, route of administration, container and pack sizes Each tablet contains 10 mg loratadine.The medicinal product is licensed for marketed in blister strips composed of aluminium and polyvinylchloride (PVC) which are packed with the Patient Information Leaflet (PIL) into cardboard outer cartons, in pack sizes of 7, 10 and 14 tablets. The container closures system and pack sizes are identical to those for the reference product. The approved shelf-life (3 years) is satisfactory. There are no special storage conditions for this product which is identical to the details registered for the cross-reference product. 2.3 Legal status This product is a general sales list (GSL) medicine. 2.4 Marketing authorisation holder/Contact Persons/Company The proposed Marketing Authorisation Holder is Relonchem Limited, 27 Old Gloucester Street, London, WC1 3XX, 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 – RelonChem Hayfever and Allergy 10 mg Tablet PL 20395/0088 - 5 - 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 cross- reference products. 2.9 Drug substance specification The proposed drug substance specification is consistent with the details registered for the cross- reference products. 2.10 TSE Compliance With the exception of lactose monohydrate, no materials of animal or human origin are included in the product. This is consistent with the cross-reference product. A declaration has been provided that lactose used in lactose monohydrate is sourced from healthy animals under the same conditions as that for human consumption. No other 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 product is a white, round, flat tablet with a scoreline and is identical to that of the cross-reference 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 user- tested format. The applicant has submitted results of PIL user testing. The results indicate that the PIL 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 is contains. Labelling Mock-up of the labelling has been provided and are satisfactory. The approved artwork is comparable to the artwork registered for the cross-reference product and complies with statutory requirements. MHRA-UKPAR – RelonChem Hayfever and Allergy 10 mg Tablet PL 20395/0088 - 6 - 7. CONCLUSIONS The data submitted with is application is acceptable. A Marketing Authorisation was, therefore, granted. MHRA-UKPAR – RelonChem Hayfever and Allergy 10 mg Tablet PL 20395/0088 - 7 - 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, Loratidine 10 mg Tablets (PL 20395/0072) authorised to Relonchem Ltd on 27 March 2009 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 products, it is not expected that the environmental exposure to loratidine will increase following the marketing approval of the proposed product. MHRA-UKPAR – RelonChem Hayfever and Allergy 10 mg Tablet PL 20395/0088 - 8 - CLINICAL ASSESSMENT This is a simple, abridged, ‘informed consent’ application made under Article 10c of EC Directive 2001/83 (as amended), cross-referring to Loratidine 10 mg Tablets (PL 20395/0072) authorised by Relonchem Ltd since 27 March 2009 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 products have 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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