Dokamox 100 mg/g premix voor gemedicineerd voer voor varkens
Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
Productkenmerken
(SPC)
12-12-2018
Openbaar beoordelingsrapport
(PAR)
23-02-2022
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Werkstoffen:
AMOXICILLINE 3-WATER
Beschikbaar vanaf:
CEVA Sante Animale B.V.
ATC-code:
QJ01CA04
INN (Algemene Internationale Benaming):
AMOXICILLINE 3-WATER
farmaceutische vorm:
Premix voor gemedicineerd voer
Toedieningsweg:
Oraal gebruik
Prescription-type:
Uitsluitend door dierenartsen te gebruiken
Therapeutisch gebied:
Amoxicillin
Autorisatie datum:
2010-07-20
Productkenmerken
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1/14
UNITED KINGDOM
VETERINARY MEDICINES DIRECTORATE
WOODHAM LANE
NEW HAW
ADDLESTONE
SURREY KT15 3LS
DECENTRALISED PROCEDURE
PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY
MEDICINAL PRODUCT
PERLIUM AMOXIVAL 100 MG/G PREMIX FOR MEDICATED FEEDING STUFF FOR PIGS
(DE/HU/IT/PL/PT/ES/UK)
Amoxivet 100 Premix for Medicated Feeding Stuff for Pigs (FR)
Dokamox 100 mg/g Premix for Medicated Feeding Stuff for Pigs (BE/NL)
DATE CREATED: SEPTEMBER 2016
Perlium Amoxival 100 mg/g Premix for Medicated Feeding Stuff for Pigs
UK/V/0612/001/DC
Ceva Animal Health Ltd
Application for Decentralised Procedure
Publicly Available Assessment Report
VMD/L4/LicApps/TEMP/138/C
2/14
MODULE 1
PRODUCT SUMMARY
EU Procedure number
UK/V/0612/001/DC
Name, strength and
pharmaceutical form
Perlium Amoxival 100 mg/g Premix for
Medicated Feeding Stuff for Pigs
Applicant
Ceva Animal Health Ltd
Unit 3, Anglo Office Park
White Lion Road
Amersham
Buckinghamshire
HP7 9FB
Active substance(s)
Amoxicillin (as Amoxicillin trihydrate)
ATC Vetcode
QJ01CA04
Target species
Pigs
Indication for use
Preventive
treatment
of
respiratory
diseases
due to _ Streptococcus suis_, limited to reducing
mortality. The presence of the disease in the
herd
should
be
established
before
the
preventive treatment.
Perlium Amoxival 100 mg/g Premix for Medicated Feeding Stuff for Pigs
UK/V/0612/001/DC
Ceva Animal Health Ltd
Application for Decentralised Procedure
Publicly Available Assessment Report
VMD/L4/LicApps/TEMP/138/C
3/14
MODULE 2
The Summary of Product Characteristics (SPC) for this product is
available on
the Product Information Database of the Veterinary Medicines
Directorate.
(www.gov.uk/check-animal-medicine-licensed)
Perlium Amoxival 100 mg/g Premix for Medicated Feeding Stuff for Pigs
UK/V/0612/001/DC
Ceva Animal Health Ltd
Application for Decentralised Procedure
Publicly Available Assessment Report
VMD/L4/LicApps/TEMP/138/C
4/14
MODULE 3
PUBLIC ASSESSMENT REPORT
Legal basis of original
application
Generic application in accordance with Article
13 (1) of Dire
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