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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
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