Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MORPHINE SULPHATE PENTAHYDRATE
Pharmachemie BV
10 Milligram
Tablet Prolonged Release
2002-02-08
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0937/002/001 Case No: 2062385 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PHARMACHEMIE BV SWENSWEG 5, P.O BOX 552, HAARLEM, 2003 RN, NETHERLANDS an authorisation, subject to the provisions of the said Regulations, in respect of the product MORPHINE SULPHATE 10 MG PROLONGED RELEASE 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 21/04/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/04/2009_ _CRN 2062385_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Morphine sulphate 10 mg prolonged release film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Morphine sulphate 10 mg, prolonged release tablets contain per tablet respectively: Morphine sulphate pentahydrate 10 mg corresponding to 7.5 mg morphine. Excipient: Lactose 102 mg/tablet For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged release film-coated tablet. Greyish pink film-coated tablets with inscription '10'. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of severe pain, particularly cancer pain and post-operative pain. 4.2 POSOLOGY AND METHOD OF Read the complete document