Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
FLUOXETINE HYDROCHLORIDE
PCO Manufacturing
N06AB03
20mg
Capsules Hard
Adults Major depressive episodes Obsessive compulsive disorder Bulimia nervosa:Prozac is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity
2007-05-18
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA0465/040/002 Case No: 2046533 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PCO MANUFACTURING LIMITED UNIT 10, ASHBOURNE BUSINESS PARK, RATH, ASHBOURNE, CO. MEATH, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product PROZAC 60MG 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 13/02/2009 until 17/05/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/02/2009_ _CRN 2046533_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prozac 60mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains fluoxetine hydrochloride equivalent to 60mg of fluoxetine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsules _Product imported from the UK:_ The capsules are cream, ‘3109’ is marked on the cap and body of the capsule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Major depressive episodes. Obsessive-compulsive disorder. Bulimia nervosa: Prozac is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity 4.2 POSOLOGY AND M Perskaitykite visą dokumentą