Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
betamethasone
Norbrook Laboratories Limited
QH02AB01
0.25 mg/tablet
Tablets
Canine
Corticosteroid
Authorised
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10999/058/001 Case No: 7006651 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: NORBROOK LABORATORIES LIMITED STATION WORKS, NEWRY, CO. DOWN BT35 6JP 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: NORBET 0.25MG TABLETS FOR DOGS 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 previously revoked, shall continue in force from 16/02/2010. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. (NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/05/2010_ _CRN 7006651_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Norbet 0.25mg Tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each tablet contains 0.25 mg Betamethasone EXCIPIENTS: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet A small white tablet. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Norbet Tablets are specifically indicated for the treatment of canine allergic dermatoses Przeczytaj cały dokument