MENINGITEC Suspension for Injection

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

MENINGOCOCCAL POLYSACCHARIDE GROUP C

Mevcut itibaren:

John Wyeth & Brother Limited

Farmasötik formu:

Suspension for Injection

Yetkilendirme tarihi:

2000-07-21

Ürün özellikleri

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