Oxytetracycline Injection 10%

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Oxytetracycline hydrochloride

Disponibil de la:

Alfasan Nederland B.V

Codul ATC:

QJ01AA06

INN (nume internaţional):

Oxytetracycline hydrochloride

Dozare:

10 percent weight/volume

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupul Terapeutică:

Cattle

Zonă Terapeutică:

oxytetracycline

Indicații terapeutice:

Antibacterial

Statutul autorizaţiei:

Authorised

Data de autorizare:

1988-10-01

Caracteristicilor produsului

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA:
10980/001/001
Case No: 7004423
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:
ALFASAN INTERNATIONAL B.V.
KUIPERSWEG 9
,
3449 JA WOERDEN
,
WOERDEN 3440AB
,
NETHERLANDS
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:
OXYTETRACYCLINE INJECTION 10%
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 previously revoked, shall continue in force
from
30/09/2008
.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: From this date of effect, 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
Oxytetracycline Injection 10%
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTIC