LEVACIDE INJECTION 75 MG/ML
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
LEVAMISOLE HYDROCHLORIDE
Available from:
Norbrook Laboratories Limited
ATC code:
QP52AE01
INN (International Name):
LEVAMISOLE HYDROCHLORIDE
Dosage:
75 Mg/Ml
Pharmaceutical form:
Solution for Injection
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: 10999/037/001A
Case No: 7007615
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:
LEVACIDE INJECTION 75 MG/ML
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 24/03/2010_
_CRN 7007615_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Levacide Injection 75 mg/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear colourless sterile solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, Sheep
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Levacide Injection is a broad spectrum anthelmintic for use in the treatment and control of nematode infections. It
should be
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