Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
GRANISETRON HYDROCHLORIDE
Teva Pharma B.V.
1 Milligram
Film Coated Tablet
2007-11-23
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0749/027/001 Case No: 2062281 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to TEVA PHARMA B.V. COMPUTERWEG 10, 3542 DR UTRECHT, NETHERLANDS an authorisation, subject to the provisions of the said Regulations, in respect of the product GRANISETRON TEVA 1 MG FILM-COATED 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 01/09/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/01/2010_ _CRN 2062281_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Granisetron Teva 1 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg granisetron as granisetron hydrochloride. Excipients: Each 1 mg tablet contains 64.88 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off white, film coated, capsule shaped tablet, debossed with “93” on one side of the tablet and with “7485” on the other side of the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Granisetron is used to prevent acute nausea and vomiting induced by cytotoxic chemotherapy and ra Aqra d-dokument sħiħ