Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
IRON DEXTRAN
Ark Animal Care Ltd
QB03AC90
IRON DEXTRAN
200 Mg/Ml
Solution for Injection
LM-Licensed Merchant
Porcine
Iron dextran
Vitamins & Minerals
Authorised
1989-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10900/010/001 Case No: 7007757 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: ARK ANIMAL CARE LTD NEWBRIDGE, CO. KILDARE, 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: ANAEMEX 200MG/ML SOLUTION FOR INJECTION 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 27/04/2010. 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 28/04/2010_ _CRN 7007757_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Anaemex 200 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance Elemental Iron as Iron Dextran Complex 200 mg Excipients Phenol 5 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A reddish brown solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Young pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For treatment and prevention of iron deficiency anaemia in piglets. 4.3 C Read the complete document