Veterinary medicinal product register

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Data selected by 741 Name fatro
Original name Strength Marketing authorisation number Marketing authorisation holder: ATCvet code Species More
Fatroximin Dry Cow 100/5 mg/ml - V/NRP/01/1372 Fatro S.p.A., Itālija QJ51XX01 dry cows Vairāk

Medicinal product information

Pharmaceutical form: intramammary suspension
International name (active substance): Rifaximin
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Fatro S.p.A., Itālija
Date of authorisation/renewal: 04-Jul-2011
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [PDF] Skat_sadaļā_Zāļu_apraksts (10-Jun-2024)
Labelling text: [PDF] Skat_sadaļā_Zāļu_apraksts (10-Jun-2024)
Summary of product characteristics: [DOCX] Zāļu_informācija_ZA_M_LI (10-Jun-2024)

Products

ID Strength Package size Primary packaging Labelling
V/NRP/01/1372-01 100 mg/deva 4 Injektors, 1 deva -
V/NRP/01/1372-02 100 mg/deva 12 Injektors, 1 deva -
Fatroximin 500/170 mg/g - V/NRP/01/1370 Fatro S.p.A., Itālija QD06AX11 cattle; pigs; sheep; goats; horses; dogs; cats; rabbits Vairāk

Medicinal product information

Pharmaceutical form: cutaneous spray, solution
International name (active substance): Rifaximin
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Fatro S.p.A., Itālija
Date of authorisation/renewal: 04-Jul-2011
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [PDF] 101219LI (10-Dec-2019)
Labelling text: [PDF] 101219M (10-Dec-2019)
Summary of product characteristics: [PDF] 101219ZA (10-Dec-2019)

Products

ID Strength Package size Primary packaging Labelling
V/NRP/01/1370-01 500 mg/170 g 1 Alumīnija balons, 170 g -
Fatroximin 100/13.4 mg/g - V/NRP/01/1371 Fatro S.p.A., Itālija QG51AA06 mares; cows Vairāk

Medicinal product information

Pharmaceutical form: intrauterine foam
International name (active substance): Rifaximin
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Fatro S.p.A., Itālija
Date of authorisation/renewal: 04-Jul-2011
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [PDF] 101219LI (10-Dec-2019)
Labelling text: [PDF] 101219M (10-Dec-2019)
Summary of product characteristics: [PDF] 101219ZA (10-Dec-2019)

Products

ID Strength Package size Primary packaging Labelling
V/NRP/01/1371-01 100 mg/deva 6 Alumīnija balons, 1 deva -
Fatroximin 300/4 mg/g - V/NRP/01/1369 Fatro S.p.A., Itālija QG51AA06 cattle; horses Vairāk

Medicinal product information

Pharmaceutical form: effervescent pessaries
International name (active substance): Rifaximin
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Fatro S.p.A., Itālija
Date of authorisation/renewal: 04-Jul-2011
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [DOC] 230724LI (23-Jul-2024)
Labelling text: [DOC] 230724M (23-Jul-2024)
Summary of product characteristics: [DOC] 230724ZA (23-Jul-2024)

Products

ID Strength Package size Primary packaging Labelling
V/NRP/01/1369-01 300 mg/pesārijs 12 Blisteris, 1 pesārijs -
V/NRP/01/1369-02 300 mg/pesārijs 36 Blisteris, 1 pesārijs -
FATROVAX RHD - EU/2/21/275/002 Fatro S.p.A., Itālija QI08AA01 rabbits Vairāk

Medicinal product information

Pharmaceutical form: suspension for injection
International name (active substance): Rabbit hemorrhagic disease virus VP1A, Rabbit hemorrhagic disease virus 2 VP1AB
Distribution category: To be used only by veterinary surgeon
Manufacturer(s) responsible for batch release Fatro S.p.A., Itālija
Date of authorisation/renewal: 16-Aug-2021
Marketing authorisation valid until: 15-Aug-2026
Marketing authorisation procedure: EU
Package leaflet: * -
Labelling text: * -
Summary of product characteristics: * -
* More detailed information available on the European Medicines Agency website

Products

ID Strength Package size Primary packaging Labelling
EU/2/21/275/002 1 Polipropilēna flakons, 50 deva -
FATROVAX RHD - EU/2/21/275/001 Fatro S.p.A., Itālija QI08AA01 rabbits Vairāk

Medicinal product information

Pharmaceutical form: suspension for injection
International name (active substance): Rabbit hemorrhagic disease virus VP1A, Rabbit hemorrhagic disease virus 2 VP1AB
Distribution category: To be used only by veterinary surgeon
Manufacturer(s) responsible for batch release Fatro S.p.A., Itālija
Date of authorisation/renewal: 16-Aug-2021
Marketing authorisation valid until: 15-Aug-2026
Marketing authorisation procedure: EU
Package leaflet: * -
Labelling text: * -
Summary of product characteristics: * -
* More detailed information available on the European Medicines Agency website

Products

ID Strength Package size Primary packaging Labelling
EU/2/21/275/001 5 Pilnšļirce, 1 deva -
FATROVAX RHD - EU/2/21/275/003 Fatro S.p.A., Itālija QI08AA01 rabbits Vairāk

Medicinal product information

Pharmaceutical form: suspension for injection
International name (active substance): Rabbit hemorrhagic disease virus VP1A, Rabbit hemorrhagic disease virus 2 VP1AB
Distribution category: To be used only by veterinary surgeon
Manufacturer(s) responsible for batch release Fatro S.p.A., Itālija
Date of authorisation/renewal: 16-Aug-2021
Marketing authorisation valid until: 15-Aug-2026
Marketing authorisation procedure: EU
Package leaflet: * -
Labelling text: * -
Summary of product characteristics: * -
* More detailed information available on the European Medicines Agency website

Products

ID Strength Package size Primary packaging Labelling
EU/2/21/275/003 1 Polipropilēna flakons, 200 deva -

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