Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
BUSPIRONE HYDROCHLORIDE
Bristol-Myers Squibb (Holdings) Limited
10 Milligram
Tablets
1988-12-12
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0048/041/002 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 10 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 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contain: buspirone hydrochloride 10 mg Excipients: Contains Lactose Anhydrous DC 111.4mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. White pillow-shaped biconvex tablets with a scoreline and “10” on one face. The scoreline is to allow breaking for ease of swallowing only. 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 POSOLO Διαβάστε το πλήρες έγγραφο