Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
VENLAFAXINE HYDROCHLORIDE
Teva Pharma B.V.
150 Milligram
Prolonged Release Capsules
2010-04-30
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0749/122/002 Case No: 2081729 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA1017/013/002. TEVA PHARMA B.V. COMPUTERWEG 10, 3542 DR UTRECHT, NETHERLANDS an authorisation, subject to the provisions of the said Regulations, in respect of the product VENIXAF XL 150 MG PROLONG-RELEASE 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 30/04/2010 until 30/03/2015. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/04/2010_ _CRN 2081729_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venixaf XL 150 mg Prolonged-release Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150mg of venlafaxine (as 169.71 mg venlafaxine hydrochloride). Excipient: Each capsule contains no more than 186.76 mg of sucrose as Sugar spheres. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard. Hard gelatin capsule with natural transparent cap and body. Each capsule contains white or whitish pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS treatment of major depressive episodes prevention of recurrence of Přečtěte si celý dokument