Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MEASLES VIRUS - ENDERS EDMONSTON STRAIN MUMPS VIRUS - JERYLYNN STRAIN RUBELLA VIRUS - WISTAR RA27/3 STRAIN
Sanofi Pasteur MSD Ltd
0.5ml Millilitre
1994-05-08
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0544/024/001 Case No: 2052579 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-RTM II POWDER AND SOLVENT FOR SOLUTION FOR INJECTON IN A PRE-FILLED SYRINGE 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 06/08/2008 until 07/05/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/08/2008_ _CRN 2052579_ _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 pre-filled syringe 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). 20,000 TCID 50 of Mumps Virus Live (Jeryl Lynn Level B strain). 1,000 TCID 50 of Rubella Virus Live (Wistar, RA 27 Read the complete document