País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
RISPERIDONE
Rowa Pharmaceuticals Limited
RISPERIDONE
1 Mg/Ml
Oral Solution
Withdrawn
2009-08-20
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0074/061/001 Case No: 2002002 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROWA PHARMACEUTICALS LIMITED BANTRY, CO. CORK, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product RISPERIDONE 1MG/ML 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 13/10/2006 until 12/10/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/10/2006_ _CRN 2002002_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Risperidone 1mg/ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml contains 1mg risperidone For excipients, see Section 6.1 3 PHARMACEUTICAL FORM Oral Solution The solution is clear and colourless. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Risperidone is indicated for the treatment of acute and chronic schizophrenic psychoses, and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted affect, emotional and social withdrawal, poverty of speech) are prominent. Risperidone also alleviates affective symptoms Leia o documento completo