RAPINOVET 10 MG/ML EMULSION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
12-05-2024
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Active ingredient:
PROPOFOL
Available from:
Schering Plough Limited
ATC code:
QN01AX10
Dosage:
10 Mg/Ml
Pharmaceutical form:
Emulsion for Injection
Therapeutic group:
Neurological Preparations
Therapeutic area:
Canine
Authorization date:
1989-07-05
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10277/030/001
Case No: 7006071
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:
SCHERING PLOUGH LIMITED
SHIRE PARK, WELWYN GARDEN CITY, HERTFORDSHIRE AL7 1TW, UNITED KINGDOM
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:
RAPINOVET 10 MG/ML EMULSION 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 06/11/2009.
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 07/11/2009_
_CRN 7006071_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rapinovet 10 mg/ml Emulsion for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Propofol
10mg
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Emulsion for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
A short-acting, intravenous, general anaesthetic for procedures of short duration, lasting up to five min
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