COVERSYL ARGININE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
PERINDOPRIL ARGININE
Available from:
S.C.A.C Limited
Dosage:
5 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2010-01-11
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PPA1593/001/001
Case No: 2069251
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
S.C.A.C LIMITED
CYGNET HOUSE, MARKET SQUARE, STAINES, MIDDLESEX TW18 4RH, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
COVERSYL ARGININE 5MG FILM-COATED TABLETS
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 11/01/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/01/2010_
_CRN 2069251_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Coversyl Arginine 5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 3.395mg perindopril corresponding to 5mg perindopril arginine.
Excipients: Also contains lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from _Poland:
Light-green, rod-shaped film-coated tablet engraved with the Servier logo on one face and scored on both edges.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension:
Treatment of hypertension.
Heart failure:
Treatment of symptomatic heart failure.
Stable
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