POULVAC ISE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
SALMONELLA ENTERITIDIS PHAGE TYPE 4 INACTIVATED
Available from:
Pfizer Healthcare Ireland
ATC code:
QI01AB01
Pharmaceutical form:
Emulsion for Injection
Therapeutic group:
Immunological - Inactivated vaccine
Therapeutic area:
Fowl - Chicken
Authorization date:
2010-05-14
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
10019/176/001
Case No: 7007815
Transferred from 10861/093/001.
The Irish Medicines Board in exercise of the powers conferred on it by the Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby
grants to: PFIZER HEALTHCARE IRELAND
RINGASKIDDY, CO. CORK, IRELAND
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:
POULVAC ISE
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 14/05/2010 until 30/05/2011.
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 27/05/2010_
_CRN 7007815_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
POULVAC iSE
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
* Potency : statistical reduction of _Salmonella _Enteritidis positive birds in vaccination/challenge test.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Emulsion for injection.
Homogeneous white-ivory emulsion.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (future breeder and future layer pullets).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of 12
Read the complete document
