PERINDOPRIL TERT-BUTYLAMINE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
PERINDOPRIL TERT-BUTYLAMINE SALT
Available from:
Les Laboratoires Servier
Dosage:
2 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2008-11-14
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)
PA0568/017/001
Case No: 2062163
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
LES LABORATOIRES SERVIER
22, RUE GARNIER, 92200 NEUILLY-SUR-SEINE, FRANCE
an authorisation, subject to the provisions of the said Regulations, in respect of the product
PERINDOPRIL TERT-BUTYLAMINE 2MG 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 28/04/2009 until 13/11/2013.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/04/2009_
_CRN 2062163_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril tert-butylamine 2mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril tert-butylamine.
One tablet contains 1.669 mg perindopril corresponding to 2 mg perindopril tert-butylamine.
Excipient: lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension:
Treatment of hypertension
Heart Failure:
Treatment of symptomatic heart failure
Stable coronary artery disease:
Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation.
4.2 POS
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