NEMOVAC

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Live pneumovirus, PL21 strain

MAH:

Merial Animal Health Limited

ATC_code:

QI01AD01

INN:

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_indication:

Immunological - Live Vaccine

authorization_status:

Authorised

authorization_date:

2000-06-08

SPC

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
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_D_
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_ _
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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