Levacide Pour-on 200mg/ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levamisole

Available from:

Norbrook Laboratories Limited

ATC code:

QP52AE01

INN (International Name):

Levamisole

Dosage:

200 milligram(s)/millilitre

Pharmaceutical form:

Pour-on solution

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

levamisole

Therapeutic indications:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

1997-12-12

Summary of Product characteristics

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA:
10999/070/001
Case No: 7003720
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
,
CAMLOUGH ROAD
,
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 POUR-ON 200MG/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
11/12/2007
.
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.)
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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Levacide Pour-on 200mg/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Levamisole (as lavamisole hydrochloride)
200 mg/ml
Excipient