Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
WARFARIN SODIUM CLATHRATE
Taro Pharmaceuticals UK Ltd.
3 Milligram
Tablets
2008-07-25
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1510/001/005 Case No: 2052491 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to TARO PHARMACEUTICALS UK LTD. LAKESIDE HOUSE, 1 FURZEGROUND WAY, STOCKLEY PARK EAST, UXBRIDGE UB11 1BD, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product WARFARIN TEVA 3 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 27/01/2009 until 25/10/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/01/2009_ _CRN 2052491_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Warfarin Teva 3 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains warfarin sodium clathrate equivalent to 3 mg warfarin sodium. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Blue, flat, capsule shaped, scored tablet with ‘WARFARIN’ on top of ‘TARO’ engraved on one side and ‘3’ on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into two equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of venous thrombosis and pulmonary Read the complete document