Delta Apomorphine Hydrochloride Solution for Injection 3 mg/ml

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Apomorphine hydrochloride

Verfügbar ab:

Acravet Ltd

INN (Internationale Bezeichnung):

Apomorphine hydrochloride

Dosierung:

3 milligram(s)/millilitre

Darreichungsform:

Solution for injection

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiegruppe:

Dogs

Anwendungsgebiete:

Neurological Preparations

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2006-03-31

Fachinformation

IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA:
10793/001/001
Case No: 7005654
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:
ACRAVET LTD
IDA INDUSTRIAL ESTATE
,
PULLEEN
,
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:
DELTA APOMORPHINE HYDROCHLORIDE SOLUTION FOR INJECTION 3 MG/ML
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
07/02/2007
.
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
Delta Apomorphine Hydrochloride Solution for Injection 3 mg/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Ap