Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
ALPRAZOLAM
PCO Manufacturing
500 Microgram
Tablets
2006-09-08
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA0465/182/002 Case No: 2054664 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PCO MANUFACTURING LIMITED UNIT 10, ASHBOURNE BUSINESS PARK, RATH, ASHBOURNE, CO. MEATH, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product XANAX 500 MICROGRAM 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 20/10/2008 until 07/09/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/10/2008_ _CRN 2054664_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xanax 500 microgram Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500micrograms alprazolam Excipients: Lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from Greece and Hungary:_ Pink, oval, biconvex, tablets scored on one side and marked 'Upjohn 55' on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ANXIETY_ Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ANXIETY_ Treatment should be Läs hela dokumentet