Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FLUOXETINE HYDROCHLORIDE
Pinewood Laboratories Ltd,
20mg/5ml MG/5ml
Oral Solution
2008-11-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0281/114/001 Case No: 2049123 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PINEWOOD LABORATORIES LTD BALLYMACARBRY, CLONMEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product FLUOXETINE 20MG/5ML ORAL SOLUTION 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 11/12/2008 until 12/11/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/12/2008_ _CRN 2049123_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluoxetine 20mg/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml contains 20 mg fluoxetine (as hydrochloride). For excipients see 6.1 3 PHARMACEUTICAL FORM Oral Solution A clear, colourless solution with a peppermint odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS a)Major depressive episodes b)Bulimia nervosa: Fluoxetine is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity. c)Obsessive-compulsive disorder. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration Fluoxetine may be taken with or without food. a) Major depressive e Read the complete document