Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
EPOETIN ALFA
Janssen-Cilag Ltd
4000 iu/ml Units/ml
Solution for Injection
1994-11-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0748/025/002 Case No: 2046681 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to JANSSEN-CILAG LTD 50-100 HOLMERS FARM WAY, HIGH WYCOMBE, BUCKINGHAMSHIRE, HP12 4EG, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product EPREX 4,000 IU/ML, SOLUTION FOR INJECTION 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 04/08/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/01/2009_ _CRN 2046681_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT EPREX 4,000 IU/ml, solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Epoetin alfa*………………………………………4000 IU/ml (33.6 micrograms per ml) A vial of 1.0 ml contains 4000 IU (33.6 micrograms) of epoetin alfa *produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric p Read the complete document