Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
MENINGOCOCCAL POLYSACCHARIDE GROUP C
John Wyeth & Brother Limited
MENINGOCOCCAL POLYSACCHARIDE GROUP C
%v/v
Suspension for Injection
Withdrawn
2009-06-30
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0022/078/001 Case No: 2038688 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to JOHN WYETH & BROTHER LIMITED TRADING AS: WYETH PHARMACEUTICALS, HUNTERCOMBE LANE SOUTH, TAPLOW, MAIDENHEAD, BERKSHIRE SL6 0PH, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product MENINGITEC %V/V SUSPENSION 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 11/07/2007 until . Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/07/2007_ _CRN 2038688_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Meningitec suspension for injection Meningococcal group C oligosaccharide conjugate vaccine (adsorbed). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5ml) contains: _Neisseria meningitidis (strain C11)_ Group C oligosaccharide…………………………………… 10 micrograms Conjugated to _Corynebacterium diphtheriae_ CRM 197 protein……………………………… approximately 15 micrograms Adsorbed on aluminium phosphate ……………………… 0.125 mg Al 3+ For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection After shaking, the vacc Olvassa el a teljes dokumentumot