VALLERGAN Syrup 7.5 MG/5ml
Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Charakterystyka produktu
(SPC)
06-05-2024
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Składnik aktywny:
TRIMEPRAZINE TARTARE
Dostępny od:
Sanofi-Aventis Ireland Limited
Dawkowanie:
7.5 MG/5ml
Forma farmaceutyczna:
Syrup
Data autoryzacji:
2005-04-08
Charakterystyka produktu
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0540/132/001
Case No: 2067670
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
SANOFI-AVENTIS IRELAND LIMITED
CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
VALLERGAN 7.5 MG / 5 ML ORAL SOLUTION.
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 22/02/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 04/03/2010_
_CRN 2067670_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vallergan 7.5 mg / 5 ml Oral Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral solution contains 7.5 mg of Alimemazine (Trimeprazine) Tartrate.
EXCIPIENTS
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
A clear, bright, straw-coloured solution with an odour of apricots.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
In the management of urticaria, pruritus (including that associated with obstructive jaundice) and senile pruritus.
2.
In short term sedation and pre-anaesthetic medication in children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The route of
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