Actikor 5 mg Film-coated Tablets for Dogs
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
15-09-2013
Summary of Product characteristics
(SPC)
15-09-2013
Active ingredient:
benazepril hydrochloride 5 mg
Available from:
Ecuphar N.V.
ATC code:
QC09AA07
Pharmaceutical form:
Tablet
Therapeutic group:
benazepril
Therapeutic area:
Dogs
Authorization date:
2011-09-29
Patient Information leaflet
Page 1 of 3
PACKAGING LEAFLET FOR:
BE
: ACTIKOR 5 MG COMPRIMÉS ENROBÉS POUR CHIENS/ FILMOMHULDE TABLETTEN VOOR HONDEN
DE
: ACTIKOR 5 MG FILMTABLETTEN FÜR HUNDE
DK
: ACTIKOR 5 MG FILMOVERTRUKNE TABLETTER TIL HUNDE
FI
: ACTIKOR 5 MG KALVOPÄÄLLYSTEISET TABLETIT KOIRALLE / FILMDRAGERADE TABLETTER FÖR
HUNDAR
FR
: ACTIKOR 5 MG COMPRIMÉ PELLICULÉ POUR CHIENS
IE
: ACTIKOR 5 MG FILM-COATED TABLETS FOR DOGS
NL
: ACTIKOR 5 MG FILMOMHULDE TABLETTEN VOOR HONDEN
PL
: ACTIKOR 5 MG TABLETKI POWLEKANE DLA PSÓW
SE
: ACTIKOR 5 MG FILMDRAGERADE TABLETTER FÖR HUNDAR
UK
: ACTIKOR 5 MG FILM-COATED TABLETS FOR DOGS
1. NAME AND ADDRESS OF THR MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Marketing authorization holder:
Ecuphar NV
Legeweg 157-i
8020 Oostkamp
Belgium
Manufacturer for batch release:
Ecuphar NV
Legeweg 157-i
8020 Oostkamp
Belgium
or
Accord Healthcare Limited
Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF,
United Kingdom
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BE
: Actikor 5 mg comprimés enrobés pour chiens/ filmomhulde tabletten voor honden
DE
: Actikor 5 mg Filmtabletten für Hunde
DK
: Actikor 5 mg filmovertrukne tabletter til hunde
FI
: Actikor 5 mg kalvopäällysteiset tabletit koiralle / filmdragerade tabletter för hundar
FR
: Actikor 5 mg comprimé pelliculé pour chiens
IE
: Actikor 5 mg film-coated tablets for dogs
NL
: Actikor 5 mg filmomhulde tabletten voor honden
PL
: Actikor 5 mg tabletki powlekane dla psów
SE
: Actikor 5 mg filmdragerade tabletter för hundar
UK
: Actikor 5 mg Film
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Summary of Product characteristics
Actikor Tablets
Part-1
Page 1 of 7
PART 1.B SUMMARY OF PRODUCT CHARACTERISTICS, LABEL & PIL:
Actikor Tablets
Part-1
Page 2 of 7
PART 1.B 1- SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
BE
: Actikor 5 mg comprimés enrobés pour chiens/ filmomhulde tabletten voor honden
DE
: Actikor 5 mg Filmtabletten für Hunde
DK : Actikor 5 mg filmovertrukne tabletter til hunde
FI
: Actikor 5 mg kalvopäällysteiset tabletit koiralle / filmdragerade tabletter för hundar
FR
: Actikor 5 mg comprimé pelliculé pour chiens
IE
: Actikor 5 mg film-coated tablets for dogs
NL
: Actikor 5 mg filmomhulde tabletten voor honden
PL
: Actikor 5 mg tabletki powlekane dla psów
SE
: Actikor 5 mg filmdragerade tabletter för hundar
UK : Actikor 5 mg Film-coated Tablets for Dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Active substance:
Benazepril 4.6 mg (equivalent to 5 mg of benazepril hydrochloride).
Excipient(s):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Yellow coloured, oval, biconvex, film-coated tablets with a breakline on one side and plain
on the other side.
The tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
TARGE
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