Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
A/BRISBANE/59/2007 (H1N1) - LIKE STRAIN (A/BRISBANE/59/2007, IVR-148) PH.EUR A/BRISBANE/10/2007 (H3N2) - LIKE STRAIN (A/URUGUAY/716/2007,NYMC X-175-C) B/BRISBANE/60/2008 - LIKE STRAIN (B/BRISBANE/60/2008)
Sanofi Pasteur MSD S.p.A.
250 %v/v
Solution for Injection
2000-09-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0973/001/001 Case No: 2067720 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI PASTEUR MSD S.P.A. VIA DEGLI ALDOBRANDESCHI, 15, 1-00163 ROMA, ITALY an authorisation, subject to the provisions of the said Regulations, in respect of the product ADDIFLU SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE. INFLUENZA VACCINE, SURFACE ANTIGEN, INACTIVATED, ADJUVANTED WITH MF59C. 1 (2009/2010 SEASON) 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 20/08/2009 until 07/06/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/08/2009_ _CRN 2067720_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ADDIFLU Suspension for Injection in pre-filled syringe Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59C. 1 (2009/2010 Season). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (haemaggultinin and neuraminidase)*, of strains A/Brisbane/59/2007 (H1N1) - like strain (A/Brisbane/59/2007, IVR-148) 15 micrograms** A/Brisbane/10/2007 (H3N2) - like strain (A/Uruguay/716/2007, NYMC X – 175C) 15 micrograms** B/Brisbane/60/2008 – like strain (B/Brisbane/60/2008) 15 Olvassa el a teljes dokumentumot