Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TRAMADOL HYDROCHLORIDE
Grunenthal Ltd
50 Milligram
Tablet Prolonged Release
2007-07-27
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1189/004/001 Case No: 2043306 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to GRUNENTHAL LTD REGUS LAKESIDE HOUSE, 1 FURZEGROUND WAY, STOCKLEY PARK EAST, UXBRIDGE, MIDDLESEX UB11 1BD, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CONTRAMAL RETARD 50MG PROLONGED-RELEASE 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 28/11/2007 until 26/07/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/11/2007_ _CRN 2043306_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Contramal retard 50mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contramal retard 50 mg prolonged-release tablets 1 prolonged-release tablet contains 50 mg tramadol hydrochloride. Excipient: Each prolonged-release tablet contains 2.5 mg lactose monohydrate (see section 4.4). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. Round, biconvex, pale yellow coloured film-coated tablets, marked with the manufacturer‘s logo on one side, marked T0 on the other side. 4 CLINICAL PARTICUL Read the complete document