Levacide Injection 75 mg/ml

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Levamisole hydrochloride

MAH:

Norbrook Laboratories Limited

ATC_code:

QP52AE01

INN:

Levamisole hydrochloride

dosage:

75 milligram(s)/millilitre

pharmaceutical_form:

Solution for injection

prescription_type:

LM: Licensed Merchant as defined in relevant national legislation

therapeutic_group:

Cattle, Sheep

therapeutic_area:

levamisole

therapeutic_indication:

Endoparasiticide

authorization_status:

Authorised

authorization_date:

1989-10-01

SPC

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.)
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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