국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
KETOPROFEN
Sanofi-Aventis Ireland Limited
2.5 %w/w
Cutaneous Gel
2005-05-20
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0540/118/001 Case No: 2066252 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ORUGESIC 2.5% W/W GEL 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 31/07/2009 until 11/10/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/07/2009_ _CRN 2066252_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Orugesic 2.5% w/w Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ketoprofen 2.5 % w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cutaneous Gel A clear, colourless or practically colourless, transparent gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the topical management of soft tissue trauma and for the relief of pain and inflammation associated with extra-articular rheumatism and osteoarthritis in joints. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Orugesic Gel is for cutaneous use. Recommended Dosage Adults: Application by gentle massage 2 to 4 times daily. Treatment should not extend beyond 6 week 전체 문서 읽기