LEVACIDE POUR-ON 200 MG/ML
Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Lastnosti izdelka
(SPC)
09-05-2024
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Aktivna sestavina:
LEVAMISOLE
Dostopno od:
Norbrook Laboratories Limited
Koda artikla:
QP52AE01
INN (mednarodno ime):
LEVAMISOLE
Odmerek:
200 Mg/Ml
Farmacevtska oblika:
Pour-on Solution
Tip zastaranja:
LM-Licensed Merchant
Terapevtska skupina:
Bovine
Terapevtsko območje:
Levamisole
Terapevtske indikacije:
Endoparasiticide
Status dovoljenje:
Authorised
Datum dovoljenje:
1997-12-12
Lastnosti izdelka
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10999/070/001
Case No: 7003720
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:
NORBROOK LABORATORIES LIMITED
STATION WORKS, CAMLOUGH ROAD, CO. DOWN BT35 6JP
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:
LEVACIDE POUR-ON 200MG/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 11/12/2007.
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.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/10/2008_
_CRN 7003720_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Levacide Pour-on 200mg/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Levamisole (as lavamisole hydrochloride)
200 mg/ml
Excipients:
Patent Blue (E131)
1 mg/ml
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Pour-on Solution
A dark blue non-aqueous solution for external use.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Levacide Pour-on is a
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