Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
APOMORPHINE HYDROCHLORIDE
Acravet Ltd
QV03AB07
APOMORPHINE HYDROCHLORIDE
3 Mg/Ml
Solution for Injection
VPO-Vet.Practitioner Only
Canine
Neurological Preparations
Neurological Preparations
Authorised
2006-03-31
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10793/001/001 Case No: 7005654 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby grants to: ACRAVET LTD IDA INDUSTRIAL ESTATE, PULLEEN, CO. CORK, IRELAND an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the Veterinary Medicinal Product: DELTA APOMORPHINE HYDROCHLORIDE SOLUTION FOR INJECTION 3 MG/ML The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may be specified in the said Schedule. The authorisation, unless previously revoked, shall continue in force from 07/02/2007. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. (NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/10/2009_ _CRN 7005654_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Delta Apomorphine Hydrochloride Solution for Injection 3 mg/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE Apomorphine Hydrochloride 3 mg/ml EXCIPIENTS: Sodium metabisulphite 1 mg/ml For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Delta Apomorphine Hydrochlor Přečtěte si celý dokument