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Logo XYZAL® film-coated tablets

For full prescribing information refer to the package insert approved by the medicines regulatory authority.

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

XYZAL® film-coated tablets

COMPOSITION:
Each film-coated tablet contains 5 mg
levocetirizine dihydrochloride

ATC CLASSIFICATION:
R06A

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.1 Antihistaminics.

PRESENTATION/PACK SIZE:
Blister strips of 7 or 30 tablets

REGISTRATION NUMBER:
XYZAL® film-coated tablets:        36/5.7.1/0425

APPLICANT:
GlaxoSmithKline South Africa (Pty) Ltd
(Co. reg. no. 1948/030135/07),
39 Hawkins Ave, Epping Industria 1, 7460

MANUFACTURER:
UCB PHARMA S.p.A., TURIN, ITALY

ORIGINAL DATE OF REGISTRATION:
27 January 2010

SOURCE:
Launch letter for Oral Solution 2014
ZAF/ALG/0004/14. A18078 07/14.

Date posted:
August 2014

FURTHER READING:
International Links
: (cut and paste the URL)
NOTE the content of these links are for reference only and may not apply to the registration criteria pertaining to The Medicines Control Council in South African.Internet links:

The electronic Medicines Compendium (eMC)
http://www.medicines.org.uk/emc/medicine/11545/PIL/Xyzal+5+mg+Tablets/
PIL: http://www.medicines.org.uk/emc/PIL.11545.latest.pdf

ACTAVIS UK
Levocetirizine dihydrochloride 5 mg film-coated tablets
http://www.medicines.org.uk/emc/medicine/24190

LEVOCETRIZINE - NHS search
http://www.evidence.nhs.uk/medicine/levocetirizine-hydrochloride

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