Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
SULFADIMIDINE
Chanelle Pharmaceuticals Manufacturing Limited
QJ01EQ
SULFADIMIDINE
99.01 %w/w
Powder for Oral Solution
POM
Bovine
Sulfonamides
Antibacterial
Authorised
1988-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10987/018/001 Case No: 7006763 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: CHANELLE PHARMACEUTICALS MANUFACTURING LIMITED LOUGHREA, CO. GALWAY, 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: SULPHA NO.2 POWDER FOR ORAL SOLUTION 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 02/11/2009. 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 05/11/2009_ _CRN 7006763_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Sulpha No.2 Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains : ACTIVE SUBSTANCE Sulfadimidine 99.01% w/w For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Calves 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Sulpha No. 2 Powder is indicated for use in calves as an anti-bacterial agent effective against sulfonamide sensitive organisms Izlasiet visu dokumentu