Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
LAMOTRIGINE
Ranbaxy Ireland Limited
50 Milligram
Dispersable Tablet
2008-12-19
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0408/071/003 Case No: 2050511 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RANBAXY IRELAND LIMITED SPAFIELD, CORK ROAD, CASHEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product LAMOTRIGINE 50 MG DISPERSIBLE 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 19/12/2008 until 18/12/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/12/2008_ _CRN 2050511_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamotrigine 50mg Dispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dispersible tablet contains 50mg of Lamotrigine. Aspartame (each tablet contains 5.0mg per tablet) For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Dispersible/chewable tablet. Lamotrigine 50mg Dispersible tablets are white to off white round tablets, debossed with ‘LI3’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy _Adults and adolescents aged 13 years and above_ - Adjunctive or monotherapy treatment of partial seizures and generalised seizure Прочитајте комплетан документ