PROPALIN SYRUP
Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Lastnosti izdelka
(SPC)
14-05-2024
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Aktivna sestavina:
PHENYLPROPANOLAMINE HYDROCHLORIDE
Dostopno od:
Vetoquinol UK Limited
Koda artikla:
QG04BX91
INN (mednarodno ime):
PHENYLPROPANOLAMINE HYDROCHLORIDE
Odmerek:
50 Mg/Ml
Farmacevtska oblika:
Oral Solution
Tip zastaranja:
POM
Terapevtska skupina:
Canine
Terapevtsko območje:
Phenylpropanolamin
Terapevtske indikacije:
Hormone
Status dovoljenje:
Authorised
Datum dovoljenje:
1993-07-14
Lastnosti izdelka
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
VPA: 10966/009/001
Case No: 7006817
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:
VETOQUINOL UK LIMITED
VETOQUINOL HOUSE, GREAT SLADE, BUCKINGHAM MK18 1PA, 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:
PROPALIN SYRUP
The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in
the Schedule.
The authorisation,unless revoked, shall continue in force from 09/08/2010.
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 10/08/2010_
_CRN 7006817_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Propalin Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Phenylpropanolamine Hydrochloride
50 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
A clear colourless syrup
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Phenylpropanolamine is a sympathomimetic agent which acts by direct stimulation of the smooth muscle of the internal
urethral sphincter. It is indicated in the management
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