XYZAL Tablets 5 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
LEVOCETIRIZINE DIHYDROCHLORIDE
Available from:
McDowell Pharmaceuticals
Dosage:
5 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2009-06-25
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)
PPA1473/023/001
Case No: 2059701
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
XYZAL 5MG 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 25/06/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/06/2009_
_CRN 2059701_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xyzal 5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
Excipients: lactose monohydrate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the United Kingdom:_
White to off-white oval film coated tablet with a Y logo on one side and plain on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idiopathic urticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The film-coated tablet mus
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