AMISULPRIDE 50 MG, 100 MG AND 200MG …

1 PAR AMISULPRIDE 50 mg, 100 mg & 200 mg tabs, & AMISULPRIDE 400 mg film-coated tabs PL 39891/0004-7 1 AMISULPRIDE 50 MG, 100 mg AND 200MG TABLETS PL 39891/0004-6 AMISULPRIDE 400MG FILM-COATED TABLETS PL 39891/0007 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after authorisation summary Summary of Product Characteristics Page 13 Product Information Leaflet Page 14 Labelling Page

2 15 PAR AMISULPRIDE 50 mg, 100 mg & 200 mg tabs, & AMISULPRIDE 400 mg film-coated tabs PL 39891/0004-7 2 AMISULPRIDE 50MG, 100MG AND 200MG TABLETS PL 39891/0004-6 AMISULPRIDE 400MG FILM-COATED TABLETS PL 39891/0007 LAY SUMMARY On 15 February 2013, the Medicines and Healthcare products Regulatory Agency (MHRA) granted Double-E Pharma Limited Marketing Authorisations for the medicinal products AMISULPRIDE 50 mg, 100 mg and 200 mg tablets, and AMISULPRIDE 400 mg film-coated tablets (PL 39891/0004-7).

3 These are prescription-only medicines (POM) used to treat schizophrenia. The active ingredient is AMISULPRIDE , which belong to a group of medicines called anti-psychotics . AMISULPRIDE is used to treat an illness called schizophrenia. Schizophrenia can make you feel, see or hear things which do not exist, have strange and frightening thoughts, change how you act and make you feel alone. Sometimes people with these symptoms may also feel tense, anxious or depressed. AMISULPRIDE works by improving disturbed thoughts, feelings and behaviour.

4 It is used to treat schizophrenia when it starts and also over the longer term. No new or unexpected safety concerns arose from these applications and it was, therefore, judged that the benefits of taking AMISULPRIDE 50 mg, 100 mg and 200 mg tablets, and AMISULPRIDE 400mg film-coated tablets outweigh the risks and Marketing Authorisations have been granted. PAR AMISULPRIDE 50 mg, 100 mg & 200 mg tabs, & AMISULPRIDE 400 mg film-coated tabs PL 39891/0004-7 3 AMISULPRIDE 50 MG, 100 mg AND 200 mg TABLETS PL 39891/004-6 AMISULPRIDE 400MG FILM-COATED TABLETS PL 39891/0007 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 assessment Page 11 PAR AMISULPRIDE 50 mg, 100 mg & 200 mg tabs.

5 & AMISULPRIDE 400 mg film-coated tabs PL 39891/0004-7 4 INTRODUCTION Based on the review of the data on quality, safety and efficacy, the MHRA granted Double-E Pharma Limited, Marketing Authorisations for the medicinal products AMISULPRIDE 50 mg, 100 mg and 200 mg tablets, and AMISULPRIDE 400mg film-coated tablets (PL 39891/0004-7) on 15 February 2013. The products are prescription-only medicines (POM) and are indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.

6 The applications were submitted under Article 10(1) of Directive 2001/83/EC, as amended, claiming to be generic medicinal products of Solian 50 mg, 100 mg , 200 mg and 400 mg tablets (Sanofi-Aventis France, France) first approved in France in January 1986. The corresponding reference products in the UK are Solian 50 mg, 100 mg , 200 mg and 400 mg tablets (PL 04425/0650-53; Aventis Pharma Limited), first authorised in the UK in No new non-clinical studies were performed, which is acceptable given that the proposed products are generic medicinal products of originator products that have been licensed for over 10 years.

7 Two single-dose, fasting, bioequivalence studies were submitted to support the applications, one with the 200MG tablet and the other with the 400 mg film-coated tablet. The bioequivalence studies were carried out in accordance with Good Clinical Practice (GCP). With the exception of the bioequivalence studies, no new clinical studies were performed, which is acceptable given that the proposed products are generic medicinal products of originator products that have been licensed for over 10 years. No new or unexpected safety concerns arose during review of information provided by the Marketing Authorisation Holder and it was, therefore, judged that the benefits of taking AMISULPRIDE 50 mg, 100 mg and 200 mg tablets, and AMISULPRIDE 400mg film-coated tablets outweigh the risks, hence Marketing Authorisations have been granted.

8 PAR AMISULPRIDE 50 mg, 100 mg & 200 mg tabs, & AMISULPRIDE 400 mg film-coated tabs PL 39891/0004-7 5 PHARMACEUTICAL ASSESSMENT ACTIVE SUBSTANCE INN: AMISULPRIDE Chemical Name: 4-amino-N-[[(2RS)-1-ethylpyrrolidin-2-yl ]methyl]-5-(ethylsulphonyl)-2-methoxyben zamide 4-amino-N-[ethyl-2-pyrrolidinyl)methyl]- 5-(ethylsulfonyl)-o-anisamide Molecular Formula: C17H27N3O4S Structure: Molecular weight: Appearance: A white or almost white crystalline powder.

9 Practically insoluble in water, freely soluble in methylene chloride and sparingly soluble in ethanol. AMISULPRIDE is the subject of a European Pharmacopoeia monograph. Manufacture All aspects of the manufacture and control of the active substance AMISULPRIDE are covered by a European Directorate for the Quality of Medicines (EDQM) Certificate of Suitability. MEDICINAL PRODUCT Other ingredients The 50 mg, 100 mg and 200 mg tablets contain the pharmaceutical excipients lactose monohydrate, methylcellulose, sodium starch glycollate (Type A), microcrystalline cellulose and magnesium stearate.

10 The 400 mg tablets contain the pharmaceutical excipients lactose monohydrate, methylcellulose, sodium starch glycollate (Type A), microcrystalline cellulose, magnesium stearate, Eudragit (E100), titanium dioxide (E171), talc and Macrogol 6000. Appropriate justifications for the inclusion of each excipient have been provided. All excipients comply with their respective European Pharmacopoeia monograph. Certificates of Analysis have been provided for all excipients, showing compliance with the proposed specifications.