QUINAPRIL Film Coated Tablet 5 Milligram

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

QUINAPRIL HYDROCHLORIDE

Available from:

Ranbaxy Ireland Limited

Dosage:

5 Milligram

Pharmaceutical form:

Film Coated Tablet

Authorization date:

2008-08-01

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)
PA0408/068/001
Case No: 2053491
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
RANBAXY IRELAND LIMITED
SPAFIELD, CORK ROAD, CASHEL, CO. TIPPERARY, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
QUINAPRIL RANBAXY 5 MG 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 30/10/2008 until 31/07/2013.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/10/2008_
_CRN 2053491_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Quinapril Ranbaxy 5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains _5_mg quinapril (as hydrochloride).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white oval tablets with a film coating. The codes “Q” and “5” are imprinted on one face of the tablet on
either side of the break line. The other face of tablet also has a break line.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Essential hypertension and decompensated heart failure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral adm
                                
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