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IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0540/137/001
Case No: 2065496
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
RAMIPRIL 1.25MG CAPSULES
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 27/10/2009 until 12/05/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/10/2009_
_CRN 2065496_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ramipril 1.25mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 1.25mg ramipril
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gelatin capsule, hard
Yellow opaque/white gelatin capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ramipril is indicated in the treatment of all grades hypertension.
Congestive heart failure; as adjunctive therapy to diuretics with or without cardiac glycosides.
Ramipril has been shown to reduce mortality when administered to patients surviving acute myocardial infarction with
clinical evidence of heart failure.
NON-DIABETIC AND DIABETIC OVERT NEPHROPA
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