Tylosin 20 % Solution for Injection

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Tylosin Tartrate

Tillgänglig från:

Alfasan Nederland B.V

ATC-kod:

QJ01FA90

INN (International namn):

Tylosin Tartrate

Dos:

20 percent weight/volume

Läkemedelsform:

Solution for injection

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk grupp:

Cattle, Pigs

Terapiområde:

tylosin

Terapeutiska indikationer:

Antibacterial

Bemyndigande status:

Authorised

Tillstånd datum:

1988-10-01

Produktens egenskaper

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA:
10980/005/001
Case No: 7005143
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:
TYLOSIN 20% 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 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
Tylosin 20 % Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
4 CL