HATCHPAK AVINEW
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
LIVE NEWCASTLE DISEASE VIRUS (VG/GA) COMPONENT
Available from:
Merial Animal Health Limited
ATC code:
QI01AD06
Dosage:
5.5-6.7 Per Cent
Pharmaceutical form:
Frozen suspension for nebuliser suspension
Therapeutic group:
Immunological - Live Vaccine
Therapeutic area:
Fowl - Chicken
Authorization date:
2008-08-08
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10857/073/001
Case No: 7001513
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:
HATCHPAK AVINEW
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 revoked, shall continue in force from 03/04/2009 until 07/08/2013.
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 04/04/2009_
_CRN 7001513_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HATCHPAK AVINEW
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
PER ONE RECONSTITUTED DOSE:
ACTIVE SUBSTANCES:
Live Newcastle disease virus, VG/GA strain, ........................................................ 5.5 to 6.7 log
10
EID
50
*
ADJUVANT(S):
Not applicable
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
* 50 per cent egg infective doses
3 PHARMACEUTICAL FORM
Frozen suspension for nebuliser suspension. Y
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