国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
PIMOBENDAN
Boehringer Ingelheim Ltd
QC01CE90
2.5 Milligram
Capsules Hard
Cardiovascular
Canine
1999-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10007/029/001 Case No: 7005708 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: BOEHRINGER INGELHEIM LTD ELLESFIELD AVENUE, BRACKNELL, BERKSHIRE RG12 8YS, 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: VETMEDIN 2.5MG CAPSULES 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 20/07/2009. 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 06/10/2009_ _CRN 7005708_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Vetmedin 2.5 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Hard capsule, orange-brown/white in colour. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of canine congestive heart failure originating from valvular insufficiency (mitral and/or tricuspid regurgitatio 完全なドキュメントを読む