Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
MORPHINE SULFATE
Ethypharm
MORPHINE SULFATE
120 Milligram
Tablet Prolonged Release
Product subject to prescription which may not be renewed (A)
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0549/015/004 Case No: 2038354 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ETHYPHARM SA 17-21 RUE ST. MATTIEU, 78550 HOUDAN, FRANCE an authorisation, subject to the provisions of the said Regulations, in respect of the product ETHIRFIN 120 MILLIGRAM TABLET PROLONGED RELEASE 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 26/06/2007 until 08/01/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/06/2007_ _CRN 2038354_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ETHIRFIN 120 mg, prolonged-release capsules hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard, prolonged-release capsule contains morphine sulphate 120 mg. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard Capsule with pink opaque cap and white opaque body with '120' printed in black on the body, containing off-white to yellowish spherical microgranules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe chronic stable pain. This medicinal product is not suitable for initiating treatment, therefore the use should be limited to patients already controlled by immediate release morphine Læs hele dokumentet