Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BUSPIRONE HYDROCHLORIDE
Bristol-Myers Squibb (Holdings) Limited
10 Milligram
Tablets
1988-12-12
License 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: Read the complete document