VETMEDIN 2.5MG CAPSULES
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
29-04-2024
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Active ingredient:
PIMOBENDAN
Available from:
Boehringer Ingelheim Ltd
ATC code:
QC01CE90
Dosage:
2.5 Milligram
Pharmaceutical form:
Capsules Hard
Therapeutic group:
Cardiovascular
Therapeutic area:
Canine
Authorization date:
1999-10-01
Summary of Product characteristics
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
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