NEMOVAC

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Live pneumovirus, PL21 strain

Available from:

Merial Animal Health Limited

ATC code:

QI01AD01

INN (International Name):

Live pneumovirus, PL21 strain

Dosage:

.

Pharmaceutical form:

Lyophilisate for suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens

Therapeutic area:

avian rhinotracheitis virus

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2000-06-08

Summary of Product characteristics

IRISH MEDICINES BOARD ACT 1995, AS AMENDED
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
VPA:
10857/035/001
Case No: 7006308
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:
MERIAL ANIMAL HEALTH LIMITED
SANDRINGHAM HOUSE
,
SANDRINGHAM AVENUE, HARLOW BUSINESS PARK, HARLOW
,
ESSEX CM19 5TG
,
UNITED KINGDOM
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:
NEMOVAC
The particulars of which are set out in the attached Schedule. The
authorisation is also subject to any special conditions as may be
specified in
the Schedule.
The authorisation,unless revoked, shall continue in force from
17/12/2009
.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: 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_
_3_
_/_
_0_
_6_
_/_
_2_
_0_
_1_
_0_
_C_
_R_
_N_
_ _
_7_
_0_
_0_
_6_
_3_
_0_
_8_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
NEMOVAC
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of reconstituted vaccine contains:
ACTIVE SUBSTANCE:
Live pneumovirus, PL21 strain, at least
2.3 log
10
CCID
50
CCID
50
= 5