Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
LAMOTRIGINE
Ranbaxy (UK) Limited
200 Milligram
Tablets
2007-10-12
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0967/012/004 Case No: 2037874 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RANBAXY (UK) LIMITED 20 BALDERTON STREET, LONDON W1K 6TL, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product LAMOTRIGINE RANBAXY 200 MG TABLETS 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 14/12/2007 until 11/10/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/01/2008_ _CRN 2037874_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamotrigine Ranbaxy 200 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg lamotrigine Excipients: 23.75 mg of lactose, 1.68 mg of sodium For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet Yellow coloured, capsule shaped, biconvex tablets debossed with ‘L’ and ‘200’ on either side of the score line on one side and a deep breakline on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _EPILEPSY_ _Adults and adolescents_ Monotherapy of: - Partial epilepsy with or without generali Đọc toàn bộ tài liệu