Veterinary medicinal product register

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Data selected by 419 Name Spizobactin vet

Original name

Strength

Marketing authorisation number

Marketing authorisation holder:

ATCvet code

Species

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:	[PDF] Skat_sadaļā_Zāļu_apraksts (08-Oct-2025)
Labelling text:	[PDF] Skat_sadaļā_Zāļu_apraksts (08-Oct-2025)
Summary of product characteristics:	[DOCX] Zāļu_informācija_ZA_M_LI (08-Oct-2025)

ID	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

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:	[PDF] Skat_sadaļā_Zāļu_apraksts (08-Oct-2025)
Labelling text:	[PDF] Skat_sadaļā_Zāļu_apraksts (08-Oct-2025)
Summary of product characteristics:	[DOCX] Zāļu_informācija_ZA_M_LI (08-Oct-2025)

ID	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

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:	[PDF] Skat_sadaļā_Zāļu_apraksts (08-Oct-2025)
Labelling text:	[PDF] Skat_sadaļā_Zāļu_apraksts (08-Oct-2025)
Summary of product characteristics:	[DOCX] Zāļu_informācija_ZA_M_LI (08-Oct-2025)

ID	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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