CETIRIZINE 10MG FILM-COATED TABLETS.
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-04-2024
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Active ingredient:
CETIRIZINE DIHYDROCHLORIDE
Available from:
McDermott Laboratories Ltd t/a Gerard Laboratories
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2006-06-13
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0577/085/001
Case No: 2085502
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MCDERMOTT LABORATORIES LTD T/A GERARD LABORATORIES
35-36 BALDOYLE INDUSTRIAL ESTATE, GRANGE ROAD, DUBLIN 13, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CETIRIZINE 10 MG FILM-COATED TABLETS
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 30/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/07/2010_
_CRN 2085502_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cetirizine 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 10mg cetirizine dihydrochloride.
Excipients: one film-coated tablet contains 74.3mg lactose-monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
White, capsule shaped, film coated tablet with breakline and marked ‘CZ’ and ‘10’ on one side and marked ‘G’ on the
reverse.
The breakline is to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults and pae
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