Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE
Abbott Laboratories Ireland Ltd
10 Milligram
Capsule
2001-05-17
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0038/075/001 Case No: 2053840 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ABBOTT LABORATORIES IRELAND LTD 4051 KINGSWOOD DRIVE, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product REDUCTIL 10MG CAPSULES, HARD 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 14/01/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/11/2009_ _CRN 2053840_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Reductil 10 mg capsules, hard. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule of Reductil 10 mg contains 10 mg of sibutramine hydrochloride monohydrate (equivalent to 8.37 mg of sibutramine). Contains 201.4 mg of lactose. For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Capsule, hard With a blue cap and yellow body 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reductil 10 mg is indicated as adjunctive therapy within a weight management programme for: o Patients with nutritional obesity and a body mass index (BMI) of 30 kg/m 2 or higher o Patients with nutritional excess we Read the complete document