Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
phenoxymethylpenicillin
Novartis Animal Health UK Ltd
QJ01CE02
10 %w/w
Premix for Med.Feedstuffs
Antibacterial
Authorised
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) 10825/013/001 Case No: 7006014 Transferred from 10835/041/001. The Irish Medicines Board in exercise of the powers conferred on it by the Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby grants to: NOVARTIS ANIMAL HEALTH UK LTD FRIMLEY BUSINESS PARK, FRIMLEY, SURREY GU16 7SR, ENGLAND 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: POTENCIL 10% PREMIX FOR MEDICATED FEED FOR PIGS 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 26/01/2010. 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 28/01/2010_ _CRN 7006014_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Potencil 10% premix for medicated feed for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Phenoxymethylpenicillin potassium (penicillin V) 10.0% w/w in an inert carrier. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Premix for medicated feed 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and control of Strepto Read the complete document