ADDIFLU SUSPENSION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
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)
Available from:
Sanofi Pasteur MSD S.p.A.
Dosage:
250 %v/v
Pharmaceutical form:
Solution for Injection
Authorization date:
2000-09-01
Summary of Product characteristics
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
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