Levacide Injection 75 mg/ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levamisole hydrochloride

Available from:

Norbrook Laboratories Limited

ATC code:

QP52AE01

INN (International Name):

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 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.)
I
R
I
S
H
M
E
D
I
C
I
N
E
S
B
O
A
R
D
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_4_
_/_
_0_
_3_
_/_
_2_
_0_
_1_
_0_
_C_
_R_
_N_
_ _
_7_
_0_
_0_
_7_
_6_
_1_
_5_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_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