OESTRADIOL BENZOATE 5 MG/ML SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-05-2024
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Active ingredient:
ESTRADIOL BENZOATE
Available from:
Intervet Ireland Limited
ATC code:
QG03CA03
Dosage:
5 Mg/Ml
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Hormone
Therapeutic area:
Bovine
Authorization date:
1987-10-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10996/017/001
Case No: 7004980
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:
INTERVET IRELAND LIMITED
MAGNA DRIVE, MAGNA BUSINESS PARK, DUBLIN 24, 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:
OESTRADIOL BENZOATE 5 MG/ML SOLUTION FOR INJECTION
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 18/08/2008.
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 19/08/2008_
_CRN 7004980_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Oestradiol Benzoate 5 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, oily solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Female animals: mares and fillies declared as not intended for human consumption
cows and bitches
Male animal: dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cows:
- Treatment of mummification
- Treatment of pyometra
Mares/fillies as
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