PAROXETINE 20 MG TABLETS PAROXETINE 30 MG TABLETS PL 40378/ UKPAR TABLE OF CONTENTS

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1 PAROXETINE 20 MG TABLETS PAROXETINE 30 MG TABLETS PL 40378/ 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 Information Leaflet Page 13 Labelling Page 14 MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 1

2 LAY SUMMARY Paroxetine 20 mg Tablets Paroxetine 30 mg Tablets (paroxetine hydrochloride anhydrous, film-coated tablets, 20 mg and 30 mg) This is a summary of the Public Assessment Report (PAR) for Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ). It explains how for Paroxetine 20 mg and 30 mg Tablets were assessed and their authorisation recommended, as well as their conditions of use. It is not intended to provide practical advice on how to use Paroxetine 20 mg and 30 mg Tablets. For practical information about using Paroxetine 20 mg and 30 mg Tablets, patients should read the package leaflet(s) or contact their doctor or pharmacist. Paroxetine 20 mg and 30 mg Tablets may be referred to as Paroxetine Tablets in this report. What are Paroxetine Tablets and what are they used for? Paroxetine Tablets are one of a type of antidepressants known as Selective Serotonin Re-uptake Inhibitors (SSRIs). Paroxetine Tablets are used in adults to treat: depression obsessive compulsive disorder panic disorder with or without agoraphobia (fear of open spaces or new situations) social anxiety disorders/social phobias post traumatic stress disorder anxiety disorders. Actavis UK Limited (trading style: Actavis) has agreed that the scientific data presented for Paroxetine 20mg and 30mg Tablets (PL 00142/ ; UK/H/0559/ /MR ) can be used to determine the applications for Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ). How are Paroxetine Tablets used? Paroxetine Tablets are taken by mouth, swallowed with a drink of water. The tablets should be taken in the morning with food. Paroxetine Tablets can be cut in half. The tablets should not be chewed. Doses: The doctor will advise the patient on the dose to take when the patient first starts taking paroxetine. The recommended doses are: Adults Depression: 20 mg a day to a maximum of 50 mg Obsessive compulsive disorder: 20 mg a day to a maximum of 60 mg Panic disorder: 10 mg a day to a maximum of 60 mg Social anxiety disorder: 20 mg a day to a maximum of 50 mg Post traumatic stress disorder: 20 mg a day to a maximum of 50 mg Anxiety disorder: 20 mg a day to a maximum of 50 mg. Elderly The maximum dose for people over 65 is 40 mg per day. Children and adolescents Not recommended for use in children aged under 18 years. Patients with liver or kidney disease The doctor may decide that patients who have trouble with the liver or kidneys should have a lower MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 2

3 dose. In patients with severe liver or kidney disease, the maximum dose is 20 mg per day. For further information on how Paroxetine Tablets are used, please refer to the Patient Information Leaflet and Summary of Product Characteristics on the MHRA website. Paroxetine Tablets can only be obtained on prescription. How do Paroxetine Tablets work? Low levels of the hormone serotonin are thought to be a cause of depression and other related conditions. The active ingredient, paroxetine (as paroxetine hydrochloride anhydrous) works by bringing the levels of serotonin back to normal. How have Paroxetine Tablets been studied? These applications are identical to previously granted applications for Paroxetine 20mg and 30mg Tablets (PL 00142/ ; UK/H/0559/ /MR). Actavis UK Limited has agreed that the scientific data presented for Paroxetine 20mg and 30mg Tablets (PL 00142/ ; UK/H/0559/ /MR) can be used for the applications for Paroxetine Tablets (PL 40378/ ). The company (Aptil Pharma Limited), referred to data provided by Actavis UK Limited for the grant of licences for Paroxetine 20mg and 30mg Tablets (PL 00142/ ; UK/H/0559/ /MR), as a basis for the grant of identical licences for Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ). What are the benefits and risks of Paroxetine tablets? As Paroxetine Tablets (PL 40378/ ) are considered identical to Paroxetine 20mg and 30mg Tablets (PL 00142/ ; UK/H/0559/ /MR), their benefits and risks are taken as being the same as those for Paroxetine 20mg and 30mg Tablets (PL 00142/ ; UK/H/0559/ /MR). Why are Paroxetine Tablets approved? No new or unexpected safety concerns arose from these applications. It was, therefore, considered that the benefits of Paroxetine Tablets outweigh their risks; and the grant of Marketing Authorisations was recommended. What measures are being taken to ensure the safe and effective use of Paroxetine Tablets? A Risk Management Plan has been developed to ensure that Paroxetine Tablets are used as safely as possible. Based on this plan, safety information has been included in the Summary of Product Characteristics and the package leaflet for Paroxetine Tablets, including the appropriate precautions to be followed by healthcare professionals and patients. Other information about Paroxetine Tablets. Marketing Authorisations were granted in the UK on 20 January For more information about treatment with Paroxetine Tablets, read the package leaflet(s), or contact your doctor or pharmacist. This summary was last updated in March The full PAR for Paroxetine Tablets follows this summary. MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 3

4 PAROXETINE 20 MG TABLETS PAROXETINE 30 MG TABLETS PL 40378/ SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 5 Pharmaceutical Assessment Page 6 Non-clinical Assessment Page 8 Clinical Assessment Page 9 Overall Conclusion and Benefit/Risk Assessment Page 10 MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 4

5 INTRODUCTION The Medicines and Healthcare products Regulatory Agency (MHRA) granted Aptil Pharma Limited Marketing Authorisations for the medicinal products Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) on 20 January The products are prescription-only medicines (POM) and are indicated for the treatment of: major depressive episodes obsessive compulsive disorder panic disorder with and without agoraphobia social anxiety disorder/social phobia generalised anxiety disorder post-traumatic stress disorder. The applications were submitted as abridged applications according to Article 10c of Directive 2001/83/EC, as amended, cross-referring to Paroxetine 20mg and 30mg Tablets (PL 00142/ ), which were authorised in the UK to Actavis UK Limited (trading style: Actavis), on 29 April Subsequently the products went through Mutual Recognition Procedures (MRP) with the UK as Reference Member State and Finland, the Netherlands and Portugal as Concerned Members States in procedure UK/H/0559/001/MR (PL 00142/0538), and the Netherlands as Concerned Member State in procedure UK/H/0559/002/MR (PL 00142/0539). The end of procedure date for the MRP was 13 January The active ingredient, paroxetine (as paroxetine hydrochloride anhydrous) is an antidepressant of the selective serotonin re-uptake inhibitor (SSRI) class. Its antidepressant action and effectiveness in the treatment of the stated conditions is thought to be related to its specific inhibition of serotonin (5-hydroxytryptamine, 5-HT) uptake in brain neurones. No new data were submitted nor were they necessary for these applications, as the data are identical to those of the previously granted cross-reference products. MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 5

6 PHARMACEUTICAL ASSESSMENT LICENCE NO: PL 40378/ PROPRIETARY NAME(S): Paroxetine 20 mg and 30 mg Tablets ACTIVE(S): Paroxetine hydrochloride anhydrous COMPANY NAME: Aptil Pharma Limited E.C. ARTICLE: Article 10c of Directive 2001/83/EC, as amended LEGAL STATUS: POM 1. INTRODUCTION These are abridged applications for Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) submitted under Article 10c of Directive 2001/83/EC, as amended. The applications cross-refer to Paroxetine 20mg and 30mg Tablets (PL 00142/ ; UK/H/0559/ /MR), which were first authorised in the UK to Actavis UK Limited on 29 April The current applications are considered valid. 2. MARKETING AUTHORISATION APPLICATION FORM 2.1 Name(s) The proposed names of the products are Paroxetine 20 mg and 30 mg Tablets. The products have been named in line with current requirements. 2.2 Strength, pharmaceutical form, route of administration, container and pack sizes Each film-coated tablet for oral use contains 20 mg or 30 mg of the active ingredient, paroxetine (as paroxetine hydrochloride anhydrous). The tablets are packaged in: 1. Aluminium/aluminium blister strips (aluminium foil thickness and laminate 25/45/60 oriented polyamide/aluminium/polyvinylchloride (20 mg and 30mg tablets) or laminate 25/45/100 oriented polyamide/aluminium/polyvinylchloride (30 mg tablets only)) in pack sizes of 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 or 500 tablets; and 1 x 50 unit dose. 2. Polypropylene tablet containers with desiccant, in pack sizes of 14, 20, 28, 30, 50, 56, 60, 98, 100, 250 and 1000 tablets. Not all pack sizes may be marketed. The proposed shelf life is 3 years. There are no special storage instructions for the products. The packaging, proposed shelf-life and absence of special storage conditions are consistent with the details registered for the cross-reference products. 2.3 Legal status On approval, the products will be available as prescription-only medicines (POM). 2.4 Marketing Authorisation Holder/Contact Persons/Company Aptil Pharma Limited, 9th Floor, CP House, Bridge Road, Ealing, London, W5 5TL The Qualified Person (QP) responsible for pharmacovigilance is stated and a satisfactory CV has been provided. 2.5 Manufacturers The proposed manufacturing sites are consistent with those registered for the cross-reference products and evidence of Good Manufacturing Practice (GMP) compliance has been provided. MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 6

7 2.6 Qualitative and quantitative composition The proposed compositions are consistent with the details registered for the cross-reference products. 2.7 Manufacturing process The proposed manufacturing process is consistent with the details registered for the cross-reference products and the maximum batch size is stated. 2.8 Finished product/shelf-life specification The proposed finished product specifications are in line with the details registered for the respective cross-reference products. 2.9 Drug substance specification The proposed drug substance specification is consistent with the details registered for the cross-reference products TSE Compliance None of the excipients contains material of animal or human origin Bioequivalence No bioequivalence data are required to support these simple abridged applications, as the proposed products are manufactured to the same formula and utilise the same processes as the reference products Paroxetine 20mg and 30mg tablets (PL 00142/ ; UK/H/0559/ /MR). 3. EXPERT REPORT The applicant cross-refers to the data for Paroxetine 20mg and 30mg Tablets (PL 00142/ ; UK/H/0559/001-00/MR), to which these applications are claimed to be identical. This is acceptable. 4. PRODUCT NAME & APPEARANCE See 2.1 for details of the proposed product names. The appearance of each product is identical to the respective cross-reference product. 5. SUMMARIES OF PRODUCT CHARACTERISTICS (SmPCs) The proposed Summaries of Product Characteristics are consistent with the details registered for the respective cross-reference products. 6. PATIENT INFORMATION LEAFLET (PIL) AND LABELLING PIL The Patient Information leaflet text has been prepared in line with the details registered for the cross-reference products. The Marketing Authorisation Holder has committed to submitting the mock-up to the regulatory authorities for approval before marketing any pack size. Carton and label The labelling text is consistent with that for the respective cross-reference products and complies with statutory requirements. In line with current legislation, the applicant has also included the names of the products in Braille on the outer packaging. The Marketing Authorisation Holder has committed to submitting mock-ups to the regulatory authorities for approval before marketing any pack size. 7. CONCLUSION The data submitted with the applications are acceptable. The grant of Marketing Authorisations is recommended. MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 7

8 NON-CLINICAL ASSESSMENT As these are abridged applications submitted under Article 10c of Directive 2001/83/EC, as amended, no new non-clinical data have been supplied and none are required. As these products are intended for substitution with products that are already marketed, it is not expected that environmental exposure will increase following approval of the Marketing Authorisations for the proposed products. An Environment Risk Assessment (ERA) was not submitted and none was required. The grant of Marketing Authorisations is recommended. MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 8

9 CLINICAL ASSESSMENT As these are abridged applications submitted under Article 10c of Directive 2001/83/EC, as amended, no new clinical data have been supplied and none are required. The Marketing Authorisation Holder has provided details of a suitable pharmacovigilance system that fulfils the requirements and provides adequate evidence that they have the services of a qualified person responsible for pharmacovigilance, and have the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country. The Risk Management Plan (RMP) is considered adequate given that the Paroxetine 20 mg and 30 mg Tablets are no different from the innovator products in terms of indication that would have any implications for safety. Routine risk minimisation is provided through the Summaries of Product Characteristics and the Patient Information Leaflet. No additional risk minimisation activities are currently considered necessary. The grant of Marketing Authorisations is recommended. MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 9

10 OVERALL CONCLUSION AND BENEFIT/RISK ASSESSMENT QUALITY The data for these applications are consistent with those previously assessed for the cross-reference products and as such have been judged to be satisfactory. NON-CLINICAL No new non-clinical data were submitted and none are required for applications of this type. EFFICACY These applications are identical to previously granted applications for Paroxetine 20mg and 30mg Tablets (PL 00142/ ; UK/H/559/ /MR). SAFETY No new safety data were supplied or required for these applications. Paroxetine has a well-established safety profile. No new or unexpected safety concerns arise from these applications. PRODUCT LITERATURE The SmPCs, PIL and labelling text are satisfactory, and consistent with those for the cross-reference products. BENEFIT/RISK ASSESSMENT The quality of the products is acceptable, and no new non-clinical or clinical safety concerns have been identified. The applicant s products are identical to the cross-reference products. Extensive clinical experience with paroxetine is considered to have demonstrated the therapeutic value of the compound. The benefit/risk balance is, therefore, considered to be positive. MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 10

11 PAROXETINE 20 MG TABLETS PAROXETINE 30 MG TABLETS PL 40378/ STEPS TAKEN FOR ASSESSMENT 1 The MHRA received the Marketing Authorisation applications on 04 July Following standard checks and communication with the applicant the MHRA considered the applications valid on 09 July Following assessment of the applications the MHRA requested further information relating to the dossier on 17 October The applicant responded to the MHRA s request, providing further information on the 26 November The applications were granted on 20 January MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 11

12 SUMMARY OF PRODUCT CHARACTERISTICS In accordance with Directive 2010/84/EU, the Summaries of Product Characteristics (SmPCs) for products granted Marketing Authorisations at a national level are available on the MHRA website. MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 12

13 PATIENT INFORMATION LEAFLET In accordance with Directive 2010/84/EU, the Patient Information Leaflets (PILs) for products granted Marketing Authorisations at a national level are available on the MHRA website. MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 13

14 LABELLING The Marketing Authorisation Holder has submitted the text version only and has committed to submitting mock-up livery to the regulatory authorities for approval before packs are marketed. MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 14

15 MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 15

16 MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 16

17 MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 17

18 MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 18

19 MHRA PAR Paroxetine 20 mg and 30 mg Tablets (PL 40378/ ) 19

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