Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SIBUTRAMINE HCI MONOHYDRATE
Teva Pharma B.V.
SIBUTRAMINE HCI MONOHYDRATE
10 Milligram
Capsule
Product subject to prescription which may not be renewed (A)
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0749/050/001 Case No: 2063148 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to TEVA PHARMA B.V. COMPUTERWEG 10, 3452 DR UTRECHT, NETHERLANDS an authorisation, subject to the provisions of the said Regulations, in respect of the product SIBUTRAMINE TEVA 10 MG 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 16/03/2009 until 19/06/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/03/2009_ _CRN 2063148_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sibutramine Teva 10 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule of Sibutramine Teva contains 10 mg of sibutramine hydrochloride monohydrate (equivalent to 8.37 mg of sibutramine) Excipients: Lactose monohydrate 112.26 mg/tablet For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Hard Capsule Sibutramine Teva 10mg Capsules are hard gelatin capsules with a blue cap printed with “S” and a white body printed with “10”. The Capsules contain a white to off-white granulate powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sibutramine is indicated as adjunctive thera Read the complete document