NEMOVAC

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

LIVE PNEUMOVIRUS PL21 STRAIN

Mevcut itibaren:

Merial Animal Health Limited

ATC kodu:

QI01AD01

INN (International Adı):

LIVE PNEUMOVIRUS PL21 STRAIN

Doz:

Unknown

Farmasötik formu:

Lyophilisate for suspension

Reçete türü:

POM

Terapötik grubu:

Fowl - Chicken

Terapötik alanı:

Avian rhinotracheitis virus vaccine

Terapötik endikasyonlar:

Immunological - Live Vaccine

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2000-06-08

Ürün özellikleri

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.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/06/2010_
_CRN 7006308_
_page number: 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
= 50% cell culture infective dose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Broiler chickens between 7 and 14 days.
Breeder and layer pullets from 14 weeks of age.
4.2 INDICATIONS FOR USE, SPECIFYING�