Metrovis 250 mg tabletten voor honden en katten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

METRONIDAZOL

Beschikbaar vanaf:

Livisto Int'l, S.L.

ATC-code:

QP51A

INN (Algemene Internationale Benaming):

METRONIDAZOLE

farmaceutische vorm:

Tablet

Samenstelling:

METRONIDAZOL 250 mg/stuk,

Toedieningsweg:

Oraal gebruik

Prescription-type:

Uitsluitend door dierenartsen te gebruiken

Therapeutische categorie:

Honden; Katten

Therapeutisch gebied:

Agents against protozoal diseases

Autorisatie-status:

NL/V/0249/002

Autorisatie datum:

2019-05-24

Productkenmerken

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COLLEGE TER BEOORDELING VAN GENEESMIDDELEN / MEDICINES EVALUATION
BOARD
GRAADT VAN ROGGENWEG 500
3531 AH UTRECHT
THE NETHERLANDS
DECENTRALISED PROCEDURE
PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY
MEDICINAL PRODUCT
METROVIS 100 MG TABLETS FOR DOGS AND CATS
METROVIS 250 MG TABLETS FOR DOGS AND CATS
METROVIS 750 MG TABLETS FOR DOGS
DATE: 9 JULY 2019
Metrovis 100 mg, 250 mg tablets for dogs and cats
Metrovis 750 mg tablets for dogs
NL/V/0249/001-003/DC
Livisto Int’l, S.L. Spain
DCP
Publicly available assessment report
2/8
_ _
Publicly available assessment report
Publicly available assessment report
MODULE 1
PRODUCT SUMMARY
Dutch Registration number
REG NL 123140, 123141, 123142
EU Procedure number
NL/V/0249/001-003/DC
Name, strength and
pharmaceutical form
Metrovis 100 mg tablets for dogs and cats
Metrovis 250 mg tablets for dogs and cats
Metrovis 750 mg tablets for dogs
Applicant
Livisto Int’l, S.L.
Av. Universitat Autònoma 29
08290 Cerdanyola del Vallès
Barcelona, Spain
Active substance(s)
Metronidazole
ATC Vetcode
QP51AA01
Target species
100 mg, 250 mg: dogs and cats
750 mg: dogs
Indication for use
Treatment
of
gastrointestinal
tract
infections
caused by _Giardia_ spp. and _Clostridia _spp. (i.e.
_C. perfringens_ or _C. difficile_).
Treatment of infections of the urogenital tract,
oral cavity, throat, and skin caused by obligate
anaerobic
bacteria
(e.g.
_Clostridia_
spp.)
susceptible to metronidazole.
Metrovis 100 mg, 250 mg tablets for dogs and cats
Metrovis 750 mg tablets for dogs
NL/V/0249/001-003/DC
Livisto Int’l, S.L. Spain
DCP
Publicly available assessment report
3/8
_ _
Publicly available assessment report
Publicly available assessment report
MODULE 2
The Summary of Product Characteristics (SPC) for this product is
available on the website:
http://mri.medagencies.org/veterinary/
Metrovis 100 mg, 250 mg tablets for dogs and cats
Metrovis 750 mg tablets for dogs
NL/V/0249/001-003/DC
Livisto Int’l, S.L. Spain
DCP
Publicly available assessment report
4/8
_ _
Publicly availabl