OVITELMIN DRENCH 5% W/V ORAL SUSPENSION
Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Характеристики продукта
(SPC)
19-05-2024
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Активный ингредиент:
MEBENDAZOLE
Доступна с:
Janssen Cilag Ltd.
код АТС:
QP52AC09
дозировка:
50 Mg/Ml
Фармацевтическая форма:
Oral Suspension
Терапевтическая группа:
Endoparasiticide
Терапевтические области:
Ovine
Дата Авторизация:
1989-10-01
Характеристики продукта
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) REGULATIONS 2007
(S.I. NO. 144 OF 2007)
VPA: 10545/002/001
Case No: 7002446
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 144 of 2007) hereby grants to:
JANSSEN CILAG LTD.
SAUNDERTON, HIGH WYCOMBE, BUCKINGHAMSHIRE HP14 4HJ, 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:
OVITELMIN DRENCH 5% W/V ORAL SUSPENSION
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.
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 07/06/2007_
_CRN 7002446_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ovitelmin Drench 5% w/v Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of roundworm, lungworm and tapeworm infestations caused by:
ROUNDWORMS:
_Haemonchus contortus_
_Cooperia _spp.
_Strongyloides papillosus_
_Oesophagostomum _spp.
_Chabertia ovina_
_Bunostomum _spp.
_Trichostrongylus _spp.
_Trichuris ovis_
_Ostertagia _sp
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