ATACAND Tablets 2 Milligram
Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Produktens egenskaper
(SPC)
06-05-2024
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Aktiva substanser:
CANDESARTAN CILEXETIL
Tillgänglig från:
AstraZeneca UK Limited
Dos:
2 Milligram
Läkemedelsform:
Tablets
Tillstånd datum:
2002-04-29
Produktens egenskaper
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0970/030/001
Case No: 2078949
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ASTRAZENECA UK LIMITED
600 CAPABILITY GREEN, LUTON, LU1 3LU, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ATACAND 2 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 12/05/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/05/2010_
_CRN 2078949_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atacand 2 mg tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg candesartan cilexetil.
Each 2 mg tablet contains 95. 4 mg lactose monohydrate.
For a full list of excipients, _see section 6.1._
3 PHARMACEUTICAL FORM
Tablet
Atacand 2 mg are round (diameter 7 mm), white tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Essential hypertension.
Treatment of patients with heart failure and impaired left ventricle systolic function (left ventricular ejection fraction
40%) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated _(see section 5.1 Pharmacodynamic_
_properties)._
4.2
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