产品特点
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0540/159/002
Case No: 2057612
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0077/104/003.
SANOFI-AVENTIS IRELAND LIMITED
CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
SOLPADOL 500 MG/30 MG HARD CAPSULES
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 03/11/2008 until 31/10/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/11/2008_
_CRN 2057612_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solpadol 500 mg/30 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Hard gelatin capsule with a light grey opaque body and purple opaque cap, printed with ‘Solpadol’ in black on both
body and cap and containing a fine white odourless powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults: Two capsules not to be taken more frequently than every 4 hours, up to a maximum of 8 capsules in any 24
hour period.
阅读完整的文件
产品特点 