VERMISOLE WORM DRENCH FOR CATTLE AND SHEEP
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-05-2024
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Active ingredient:
LEVAMISOLE HYDROCHLORIDE
Available from:
Bimeda Chemicals
ATC code:
QP52AE01
INN (International Name):
LEVAMISOLE HYDROCHLORIDE
Dosage:
1.5 %w/v
Pharmaceutical form:
Oral Solution
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Bovine, Ovine
Therapeutic area:
Levamisole
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization date:
1989-10-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10126/016/001
Case No: 7006224
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:
BIMEDA CHEMICALS
BROOMHILL ROAD, TALLAGHT, 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:
VERMISOLE WORM DRENCH FOR CATTLE AND SHEEP
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 30/09/2009.
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 01/05/2010_
_CRN 7006224_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vermisole Worm Drench for Cattle and Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
A clear yellow liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of lungworm and stomach and bowel worm infestation in cattle and sheep, caused by the
fol
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