Levacide Injection 75 mg/ml

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Levamisole hydrochloride

Διαθέσιμο από:

Norbrook Laboratories Limited

Φαρμακολογική κατηγορία (ATC):

QP52AE01

INN (Διεθνής Όνομα):

Levamisole hydrochloride

Δοσολογία:

75 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

LM: Licensed Merchant as defined in relevant national legislation

Θεραπευτική ομάδα:

Cattle, Sheep

Θεραπευτική περιοχή:

levamisole

Θεραπευτικές ενδείξεις:

Endoparasiticide

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

1989-10-01

Αρχείο Π.Χ.Π.

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