Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
PHENOXYMETHYLPENICILLIN POTASSIUM
Intervet Ireland Limited
QJ01CE02
10 %w/w
Premix for Med.Feedstuffs
Antibacterial
Porcine
1997-02-21
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10996/050/001 Case No: 7005189 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: INTERVET IRELAND LIMITED MAGNA DRIVE, MAGNA BUSINESS PARK, DUBLIN 24, 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: PEN V 10% INTERVET 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 the said Schedule. The authorisation,unless revoked, shall continue in force from 07/05/2009. 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 08/05/2009_ _CRN 7005189_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Pen V 10% Intervet premix for medicated feedingstuff 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance Phenoxymethylpenicillin potassium 10% w/w in an inert base For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Premix for medicated feedingstuff 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is indicated for the treatment of penicillin sensitive in Citiți documentul complet