Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
LAMOTRIGINE
Ergha Healthcare Ltd
100 Milligram
Tablets
2006-08-25
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0966/016/005 Case No: 2054755 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ERGHA HEALTHCARE LTD DAMASTOWN, MULHUDDART, DUBLIN 15 an authorisation, subject to the provisions of the said Regulations, in respect of the product BYMOT 100 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 17/02/2009 until 24/08/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/02/2009_ _CRN 2054755_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bymot 100 mg Dispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dispersible tablet contains 100 mg lamotrigine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Dispersible tablet White to off white, round tablet, debossed with the number “100” on one side and “DLT” on the other. 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 seizures, including tonic-clonic seizures. - Seizures associated with Lennox-Gastaut syndrome. Lamotrigine is given asadjunctive Διαβάστε το πλήρες έγγραφο