MARBOCYL 1% SA, powder and solvent for solution for injection, for cats and dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Marbofloxacin

Available from:

Vetoquinol Ireland Limited

ATC code:

QJ01MA93

INN (International Name):

Marbofloxacin

Dosage:

1 percent weight/volume

Pharmaceutical form:

Powder and solvent for solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

marbofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2000-02-18

Summary of Product characteristics

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA:
10983/037/001
Case No: 7006206
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:
VETOQUINOL IRELAND LIMITED
10 LAD LANE
,
LOWER BAGGOT STREET
,
DUBLIN 2
,
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:
MARBOCYL 1% SA, POWDER AND SOLVENT FOR 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
05/06/2009
until
29/09/2013
.
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.)
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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
MARBOCYL 1% SA, powder and solvent for solution for injection, for
cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHAR