M-M-R ﾙ II POWDER AND SOLVENT FOR SOLUTION FOR INJ
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-05-2024
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Active ingredient:
MEASLES VIRUS LIVE ATTENUATED DERIVED FROM THE EDMONSTON B STRAIN MUMPS VIRUS - JERYLYNN STRAIN RUBELLA VIRUS (WISTAR RA 27/3 STRAIN) LIVE ATTENUATED
Available from:
Sanofi Pasteur MSD Ltd
Pharmaceutical form:
Pdr+Solv for Soln for Inj
Authorization date:
2005-06-17
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)
PA0544/024/002
Case No: 2040619
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
SANOFI PASTEUR MSD LTD
BLOCK A, SECOND FLOOR, COOKSTOWN COURT, OLD BELGARD ROAD, TALLAGHT, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
M-M-R ™ II POWDER AND SOLVENT FOR SOLUTION FOR INJECTON IN A VIAL MEASLES, MUMPS AND RUBELLA VACCINE, LIVE, ATTENUATED
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 22/09/2008 until 16/06/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/09/2008_
_CRN 2040619_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
M-M-R
TM
II
Powder and Solvent for Solution for Injection in a vial
Measles, Mumps and Rubella Vaccine, Live, Attenuated
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 millilitre dose when reconstituted contains not less than equivalent of:
1,000 TCID
50
* of measles Virus Live.
(the more attenuated Enders Line of the Edmonston strain).
20,00 TCID
50
of Mumps Virus Live (Jeryl Lynn Level B strain).
1,000 TCID
50
of Rubella Virus Live (Wistar, RA 27/3 Strain).
*Tissue Cult
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