Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
AMISULPRIDE
Sanofi-Aventis Ireland Limited
100 Mg/Ml
Oral Solution
2008-06-20
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0540/158/005 Case No: 2053368 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product SOLIAN 100MG/ML ORAL SOLUTION 100 MICROMOL 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 08/07/2008 until 31/08/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 09/07/2008_ _CRN 2053368_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Solian 100mg/ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amisulpride 100 mg/ml. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Oral solution A clear yellow liquid with an odour of caramel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Solian is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms. 4.2 PO Preberite celoten dokument