País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
ALPRAZOLAM
PCO Manufacturing
1 Milligram
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) PPA0465/182/003 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 1MG 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 1mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1mg alprazolam. Excipients: Lactose For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet _Product imported from Greece:_ Lavender, oval, biconvex tablets scored on one side and marked ' Upjohn 90' 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 as short as possible. The overall dura Leer el documento completo