Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CHLORTETRACYCLINE HYDROCHLORIDE
Alpharma BVBA
QJ01AA03
100 mg/g
Premix for Med.Feedstuffs
Antibacterial
Fowl - Chicken
2008-05-02
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA:10802/002/001 Case No: 7003363 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: ALPHARMA BVBA LAARSTRAAT 16, 2610 ANTWERP, BELGIUM 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: CTC ALPHARMA 100 MG/G GRANULAR PREMIX FOR MEDICATED FEEDINGSTUFF 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 Part 2 of the said Schedule. This authorisation,unless previously revoked, shall continue in force from 02/05/2008 to 01/05/2013. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/05/2008_ _CRN 7003363_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT CTC Alpharma100 mg/g Granular Premix for medicated feedingstuff 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE(S): Chlortetracycline hydrochloride 100 mg/g For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Premix for medicated feeding stuff Granular yellow powder 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs and chickens 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs As an aid in the treatment and control of swine respiratory disease complex associated with chlortetracycline-sensitive organisms. Chick Read the complete document