ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE TEVA
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE
Available from:
Teva Pharma B.V.
Dosage:
20/12.5 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2007-06-01
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)
PA0749/029/001
Case No: 2072784
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
TEVA PHARMA B.V.
COMPUTERWEG 10, 3542 DR UTRECHT, NETHERLANDS
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ENALAPRIL MALEATE HYDROCHLOROTHIAZIDE TEVA 20 MG/12.5 MG 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 30/03/2010 until 31/05/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/03/2010_
_CRN 2072784_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Enalapril Maleate Hydrochlorothiazide Teva 20 mg/12.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide (HCT).
Excipients:
Each tablet contains 140 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round, slightly arched tablets, debossed “EL”, “20” and scoreline on one side and plain on the other.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
This
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