Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
FENTANYL
Rowex Ltd
FENTANYL
25 Microgram
Transdermal Patch
Withdrawn
2008-11-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0711/070/001 Case No: 2043337 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROWEX LTD BANTRY, CO. CORK, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product FENTANYL 25 MICROGRAMS/HOUR TRANSDERMAL PATCH 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 21/02/2008 until 19/05/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/03/2008_ _CRN 2043337_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fentanyl 25 micrograms/hour Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each transdermal patch (active surface area 10 cm²) contains 2.5 mg fentanyl (corresponding to 25 microgram/hour fentanyl release rate). For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch Transparent and oblong transdermal patch which consists of a protective layer (to be removed prior to application of the patch) and four functional layers: an occlusive backing, a drug reservoir, a release membrane and an adhesive surface. _Surface area of the transdermal patch:_ Fentanyl 25 micrograms/hour Transdermal Patch: 10 cm² 4 C Aqra d-dokument sħiħ