Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
FLUOXETINE HYDROCHLORIDE
Eli Lilly and Company Limited
FLUOXETINE HYDROCHLORIDE
90 Milligram
Capsules Gastro-Resistant
Withdrawn
2008-07-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0047/077/005 Case No: 2039101 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ELI LILLY AND COMPANY LIMITED LILLY HOUSE, PRIESTLEY ROAD, BASINGSTOKE, HAMPSHIRE, RG24 9NL, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product PROZAC WEEKLY 90MG HARD GASTRO-RESISTANT 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 09/08/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/09/2007_ _CRN 2039101_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prozac Weekly 90 mg hard gastro-resistant capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains fluoxetine hydrochloride equivalent to 90 mg of fluoxetine base. Excipients: Sucrose ranging from 129.8 to 164.9 mg per capsule. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard gastro-resistant capsule. Capsules, with green cap and clear body, imprinted with “Lilly” on cap, and “334” and “90 mg” on body. The capsules contain gastro-resistant pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prozac Weekly is indica Прочитайте повний документ