País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
CODEINE PHOSPHATE
Ranbaxy Ireland Limited
60 Milligram
Tablets
1992-02-24
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0408/042/003 Case No: 2046546 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 CODEINE PHOSPHATE TABLETS BP 60 MG 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 10/03/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/03/2008_ _CRN 2046546_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Codeine Phosphate Tablets BP 60 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 60mg codeine phophate. Excipient: Also contains 73.1 mg lactose (as monohydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, circular, biconvex tablet about 7.1 mm in diameter, embossed with ‘R117’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS: As an analgesic in mild to moderate pain, as an anti-tussive, and for the treatment of chronic diarrhoea. CHILDREN: As an analgesic in mild to moderate pain and for occasional use in the control of intractable diarrhoe Llegiu el document complet