Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
TRAMADOL HYDROCHLORIDE
Helsinn Birex Therapeutics Ltd
50 Milligram
Capsule
2009-03-27
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0915/026/001 Case No: 2080524 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to HELSINN BIREX THERAPEUTICS LTD DAMASTOWN, MULHUDDART, DUBLIN 15, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BY-MADOL 50MG 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 11/05/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/05/2010_ _CRN 2080524_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT By-Madol 50mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 50 mg tramadol hydrochloride. Excipients: Lactose monohydrate 103.0mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Capsules have a hard, yellow cap and a green body. Each capsule is printed 'TRA50' on the cap and body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Management (treatment and prevention) of severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION As with all analgesics, the dose of By-Madol should be adjusted according to the severity of the pain and the clinical response of the individual Baca dokumen lengkapnya