Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
DICLOFENAC SODIUM
Astellas Pharma Co. Ltd
25
Solution for Injection
2006-06-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1241/012/006 Case No: 2071627 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ASTELLAS PHARMA CO. LTD 25 THE COURTYARD, KILCARBERY BUSINESS PARK, CLONDALKIN, DUBLIN 22, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product DIFENE AMPOULES 75 MG/3 ML 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 16/02/2010 until 27/08/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 17/02/2010_ _CRN 2071627_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Difene ampoules 75 mg/3 ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains Diclofenac sodium 75mg/3ml. Each ampoule contains 25mg/ml of diclofenac sodium. For list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for intramuscular injection or concentrate for solution for infusion. A clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intramuscular use: Difene can be used in the symptomatic management of acute exacerbation of rheumatoid arthritis and osteoarthritis, in acute back pain, acute gout, post operative pain, relief of pain in acute tr Lesen Sie das vollständige Dokument