Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TIAGABINE
Cephalon UK Limited
10 Milligram
Film Coated Tablet
2001-06-14
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0827/003/003 Case No: 2082959 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CEPHALON UK LIMITED 1 ALBANY PLACE, HYDE WAY, WELWYN GARDEN CITY, HERTFORDSHIRE, AL7 3BT, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product GABITRIL 10 MG, FILM-COATED TABLET The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 19/05/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/06/2010_ _CRN 2082959_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabitril 10 mg, film-coated tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Gabitril 10 mg tablet contains: Tiagabine 10 mg (as hydrochloride monohydrate) Excipients: Each Gabitril 10 mg film-coated tablet contains 117 mg of lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gabitril 10 mg film-coated tablet is a white, oval biconvex film-coated tablet embossed on one side with "252". 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Add-on treatment of partial seizures with or without secondary generalisation which are not satisfactorily controlled wit Read the complete document