देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
IVERMECTIN
Virbac De Portugal Laboratorios
QP54AA01
18.7 mg/g
Oral Paste
Endoparasiticide
Equine - Food
2004-09-03
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10850/005/001 Case No: 7007538 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: VIRBAC DE PORTUGAL LABORATORIOS RUA DIONISIO SARAIVA, LOTE 1, 1 ANDAR, PORTA 2, PORTUGAL 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: EQUIMEL 18.7 MG/G ORAL PASTE 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 revoked, shall continue in force from 01/04/2010 until . Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. (NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 02/04/2010_ _CRN 7007538_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT EQUIMEL 18.7 mg/g ORAL PASTE 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g contains: Active Substance: Ivermectin 18.7 mg. Excipients: Titanium dioxide E171 as a colouring agent, Hydrogenated castor oil, Hydroxypropylcellulose and Propylene glycol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral paste. White and thick paste. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. IRISH MEDICINES BOARD __________________________________ पूरा दस्तावेज़ पढ़ें