Veterinary medicinal product register

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Data selected by 811 Name Spizobactin vet
Original name Strength Marketing authorisation number Marketing authorisation holder: ATCvet code Species More
Spizobactin vet 750000 IU/125 mg - V/DCP/17/0037 Le Vet Beheer B.V., Nīderlande QJ01RA04 dogs Vairāk

Medicinal product information

Pharmaceutical form: chewable tablets
International name (active substance): Spiramycin, Metronidazole
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Lelypharma B.V., Nīderlande;GENERA Inc., Horvātija
Date of authorisation/renewal: 27-Sep-2022
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: DCP
Package leaflet: [DOCX] 11032024LI (11-Mar-2024)
Labelling text: [DOCX] 11032024M (11-Mar-2024)
Summary of product characteristics: [DOCX] 11032024ZA (11-Mar-2024)

Products

ID Strength Package size Primary packaging Labelling
V/DCP/17/0037-01 1 Blisteris, 10 tablete -
V/DCP/17/0037-02 2 Blisteris, 10 tablete -
V/DCP/17/0037-03 3 Blisteris, 10 tablete -
V/DCP/17/0037-04 10 Kastīte ar blisteri, 10 tablete -
V/DCP/17/0037-05 10 PVDH/PE/PVH/Al blisteris, 10 tablete -
Spizobactin vet 1500000 IU/250 mg - V/DCP/17/0038 Le Vet Beheer B.V., Nīderlande QJ01RA04 dogs Vairāk

Medicinal product information

Pharmaceutical form: chewable tablets
International name (active substance): Spiramycin, Metronidazole
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Lelypharma B.V., Nīderlande;GENERA Inc., Horvātija
Date of authorisation/renewal: 27-Sep-2022
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: DCP
Package leaflet: [DOCX] 11032024LI (11-Mar-2024)
Labelling text: [DOCX] 11032024M (11-Mar-2024)
Summary of product characteristics: [DOCX] 11032024ZA (11-Mar-2024)

Products

ID Strength Package size Primary packaging Labelling
V/DCP/17/0038-01 1 Blisteris, 10 tablete -
V/DCP/17/0038-02 2 Blisteris, 10 tablete -
V/DCP/17/0038-03 3 Blisteris, 10 tablete -
V/DCP/17/0038-04 10 Kastīte ar blisteri, 10 tablete -
V/DCP/17/0038-05 10 PVDH/PE/PVH/Al blisteris, 10 tablete -
Spizobactin vet 3000000 IU/500 mg - V/DCP/17/0039 Le Vet Beheer B.V., Nīderlande QJ01RA04 dogs Vairāk

Medicinal product information

Pharmaceutical form: chewable tablets
International name (active substance): Spiramycin, Metronidazole
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Lelypharma B.V., Nīderlande;GENERA Inc., Horvātija
Date of authorisation/renewal: 27-Sep-2022
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: DCP
Package leaflet: [DOCX] 11032024LI (11-Mar-2024)
Labelling text: [DOCX] 11032024M (11-Mar-2024)
Summary of product characteristics: [DOCX] 11032024ZA (11-Mar-2024)

Products

ID Strength Package size Primary packaging Labelling
V/DCP/17/0039-01 1 Blisteris, 10 tablete -
V/DCP/17/0039-02 2 Blisteris, 10 tablete -
V/DCP/17/0039-03 3 Blisteris, 10 tablete -
V/DCP/17/0039-04 10 Kastīte ar blisteri, 10 tablete -
V/DCP/17/0039-05 10 PVDH/PE/PVH/Al blisteris, 10 tablete -

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