Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
IVERMECTIN
Merial Animal Health Limited
QP54AA01
10 Mg/Ml
Solution for Injection
Endectoparasiticides
Porcine
1999-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10857/060/001A Case No: 7006088 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: MERIAL ANIMAL HEALTH LIMITED SANDRINGHAM HOUSE, SANDRINGHAM AVENUE, HARLOW BUSINESS PARK, HARLOW, ESSEX CM19 5TG, UNITED KINGDOM 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: IVOMEC INJECTION FOR PIGS 10 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 30/09/2009. 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 15/12/2009_ _CRN 7006088_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT IVOMEC Injection for Pigs 10 mg/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Ivermectin 10 mg For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs IRISH MEDICINES BOARD _______________________________________________________________________________________________ Preberite celoten dokument