COZAAR Film Coated Tablet 100 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
LOSARTAN POTASSIUM
Available from:
McDowell Pharmaceuticals
Dosage:
100 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2009-06-19
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)
PPA1473/017/002
Case No: 2059694
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MCDOWELL PHARMACEUTICALS
4 ALTONA ROAD, LISBURN, N. IRELAND, BT27 5QB
an authorisation, subject to the provisions of the said Regulations, in respect of the product
COZAAR 100MG 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 19/06/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/06/2009_
_CRN 2059694_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cozaar 100mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 91.6mg of Losartan present as 100mg of Losartan potassium.
Excipients-Contains Lactose Monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film Coated Tablet
_Product imported from _UK
White, teardrop-shaped tablet with ‘960’ on one side and plain on the other
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria
≥ 0.5 g/day as
part of an antihypertens
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