Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
PARACETAMOL CODEINE PHOSPHATE
Sanofi-Aventis Ireland Limited
500/30 Milligram
Capsule
2008-11-03
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. Belgenin tamamını okuyun