ACP SOLUTION FOR INJECTION 10MG/ML
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
ACEPROMAZINE MALEATE
Available from:
Novartis Animal Health Ireland Ltd
ATC code:
QN05AA04
Dosage:
10 Mg/Ml
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Neurological Preparations
Therapeutic area:
Equine Non Food
Authorization date:
2000-10-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10835/009/001
Case No: 7003285
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:
NOVARTIS ANIMAL HEALTH IRELAND LTD
INDUSTRIAL PARK, CORK ROAD, WATERFORD
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:
ACP SOLUTION FOR INJECTION 10MG/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 revoked, shall continue in force from 11/08/2008 until 30/09/2010.
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 14/08/2008_
_CRN 7003285_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
ACP Solution for Injection 10mg/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses declared as not intended for human consumption.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_Anaesthetic Premedication: _Following acepromazine administration, the amount of anaesthetic necessary to induce
anaesthesia is cons
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