CELIPROLOL HYDROCHLORIDE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
CELIPROLOL HYDROCHLORIDE
Available from:
Ranbaxy Ireland Limited
Dosage:
400 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2003-12-18
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0408/058/002
Case No: 2085471
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
CELIPROLOL HYDROCHLORIDE, 400 MILLIGRAM
the particulars of which are set out in 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 06/08/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/08/2010_
_CRN 2085471_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Celiprolol hydrochloride 400 mg film coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg celiprolol hydrochloride.
Each tablet contains 3.6mg lactose.
For a full list of excipients, _see section 6.1._
3 PHARMACEUTICAL FORM
Film-coated tablet.
White coloured, capsule shaped, biconvex film coated tablets, debossed with ‘400’ on one side of the breakline and a
deep breakline on the other side.
The tablet can be broken into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Celiprolol is indicated for the treatment of hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults: _The initial
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