Veterinary medicinal product register

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Data selected by 263 Name Tsefalen

Original name

Strength

Marketing authorisation number

Marketing authorisation holder:

ATCvet code

Species

Tsefalen

500 mg

V/DCP/12/0057

NEXTMUNE ITALY S.R.L., Itālija

QJ01DB01

dogs

Medicinal product information

Pharmaceutical form:	film-coated tablets
International name (active substance):	Cefalexin monohydrate
Distribution category:	To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release	Facta Farmaceutici Spa , Itālija
Date of authorisation/renewal:	31-Jul-2017
Marketing authorisation valid until:	Unlimited time period
Marketing authorisation procedure:	DCP
Package leaflet:	[PDF] Skat_sadaļā_Zāļu_apraksts (25-Feb-2025)
Labelling text:	[PDF] Skat_sadaļā_Zāļu_apraksts (25-Feb-2025)
Summary of product characteristics:	[DOCX] Zāļu_informācija_ZA_M_LI (25-Feb-2025)

ID	Strength	Package size	Primary packaging	Labelling
V/DCP/12/0057-01	500 mg	1	PVH/Al blisteris, 12 tablete	-
V/DCP/12/0057-02	500 mg	9	PVH/Al blisteris, 12 tablete	-
V/DCP/12/0057-03	500 mg	3	PVH/Al blisteris, 12 tablete	-

Tsefalen

50 mg/ml

V/DCP/20/0050

NEXTMUNE ITALY S.R.L., Itālija

QJ01DB01

dogs; cats

Vairāk

Pharmaceutical form:	Powder for oral suspension
International name (active substance):	Cefalexin
Distribution category:	To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release	Facta Farmaceutici Spa , Itālija
Date of authorisation/renewal:	28-Jan-2022
Marketing authorisation valid until:	Unlimited time period
Marketing authorisation procedure:	DCP
Package leaflet:	[PDF] Skat_sadaļā_Zāļu_apraksts (25-Feb-2025)
Labelling text:	[PDF] Skat_sadaļā_Zāļu_apraksts (25-Feb-2025)
Summary of product characteristics:	[DOCX] Zāļu_informācija_ZA_M_LI (25-Feb-2025)

ID	Strength	Package size	Primary packaging	Labelling
V/DCP/20/0050-01	50 mg/ml	1	ABPE pudele, 66,6 g	-
V/DCP/20/0050-02	50 mg/ml	1	ABPE pudele, 40 g	-

Tsefalen

1000 mg

V/DCP/12/0058

NEXTMUNE ITALY S.R.L., Itālija

QJ01DB01

dogs

Vairāk

Pharmaceutical form:	film-coated tablets
International name (active substance):	Cefalexin monohydrate
Distribution category:	To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release	Facta Farmaceutici Spa , Itālija
Date of authorisation/renewal:	31-Jul-2017
Marketing authorisation valid until:	Unlimited time period
Marketing authorisation procedure:	DCP
Package leaflet:	[PDF] Skat_sadaļā_Zāļu_apraksts (25-Feb-2025)
Labelling text:	[PDF] Skat_sadaļā_Zāļu_apraksts (25-Feb-2025)
Summary of product characteristics:	[DOCX] Zāļu_informācija_ZA_M_LI (25-Feb-2025)

ID	Strength	Package size	Primary packaging	Labelling
V/DCP/12/0058-01	1000 mg	1	PVH/Al blisteris, 8 tablete	-
V/DCP/12/0058-02	1000 mg	13	PVH/Al blisteris, 8 tablete	-
V/DCP/12/0058-03	1000 mg	4	PVH/Al blisteris, 8 tablete	-

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