Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
BUSPIRONE HYDROCHLORIDE
Bristol-Myers Squibb (Holdings) Limited
BUSPIRONE HYDROCHLORIDE
5 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-02-01
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0048/041/001 Case No: 2060646 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BRISTOL-MYERS SQUIBB (HOLDINGS) T/A BRISTOL-MYERS PHARMACEUTICALS, SWORDS, CO. DUBLIN, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BUSPAR 5 MG 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 12/12/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/06/2010_ _CRN 2060646_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Buspar 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: buspirone hydrochloride 5mg. Excipients: contains Lactose Anhydrous DC 55.7mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. White pillow-shaped biconvex tablets marked “5” on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Buspar is indicated for the short-term management of anxiety disorders and the relief of symptoms of anxiety with or without accompanying depression. Treatment should usually be limited to 4-12 weeks. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Dosage should be adjusted according to respons Прочетете целия документ