Veterinary medicinal product register

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Data selected by Name synulox
Original name Strength Marketing authorisation number Marketing authorisation holder: ATCvet code Species More
Synulox RTU - V/NRP/02/1476 Zoetis Belgium S.A., Beļģija QJ01CR02 cattle; pigs; dogs; cats Vairāk

Medicinal product information

Pharmaceutical form: suspension for injection
International name (active substance): Amoxicillin trihydrate, Potassium clavulanate
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Haupt Pharma Latina S.R.L., Itālija
Date of authorisation/renewal: 07-Dec-2012
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [PDF] Skat_sadaļā_Zāļu_apraksts (29-May-2023)
Labelling text: [PDF] Skat_sadaļā_Zāļu_apraksts (29-May-2023)
Summary of product characteristics: [DOCX] Zāļu_informācija_ZA_M_LI (30-May-2023)

Products

ID Strength Package size Primary packaging Labelling
V/NRP/02/1476-01 1 Flakons, 100 ml -
V/NRP/02/1476-02 1 Flakons, 40 ml -
V/NRP/02/1476-03 12 Flakons, 40 ml -
V/NRP/02/1476-04 6 Flakons, 100 ml [PDF] [PDF]
Synulox LC - V/MRP/98/0770 Zoetis Belgium S.A., Beļģija QJ51RV01 lactating cows Vairāk

Medicinal product information

Pharmaceutical form: intramammary suspension
International name (active substance): Amoxicillin trihydrate, Prednisolone acetate, Potassium clavulanate
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Haupt Pharma Latina S.R.L., Itālija
Date of authorisation/renewal: 13-Jun-2008
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [PDF] Skat_sadaļā_Zāļu_apraksts (31-May-2023)
Labelling text: [PDF] Skat_sadaļā_Zāļu_apraksts (31-May-2023)
Summary of product characteristics: [DOCX] Zāļu_informācija_ZA_M_LI (06-Nov-2023)

Products

ID Strength Package size Primary packaging Labelling
V/MRP/98/0770-01 24 Injektors, 1 deva -
V/MRP/98/0770-02 300 Injektors, 1 deva -
V/MRP/98/0770-04 3 Injektors, 1 deva -
V/MRP/98/0770-05 12 Injektors, 1 deva -
Synulox 500 mg - V/NRP/09/0026 Zoetis Belgium S.A., Beļģija QJ01CR02 dogs Vairāk

Medicinal product information

Pharmaceutical form: tablets
International name (active substance): Amoxicillin trihydrate, Potassium clavulanate
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Haupt Pharma Latina S.R.L., Itālija
Date of authorisation/renewal: 03-Dec-2009
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [PDF] Skat_sadaļā_Zāļu_apraksts (24-Apr-2023)
Labelling text: [PDF] Skat_sadaļā_Zāļu_apraksts (24-Apr-2023)
Summary of product characteristics: [DOCX] Zāļu_informācija_ZA_M_LI (24-Apr-2023)

Products

ID Strength Package size Primary packaging Labelling
V/NRP/09/0026-01 500 mg 5 Blisteris, 2 tablete -
V/NRP/09/0026-02 500 mg 10 Blisteris, 2 tablete -
V/NRP/09/0026-03 500 mg 50 Blisteris, 2 tablete [PDF] [PDF]
Synulox 50 mg - V/NRP/99/1027 Zoetis Belgium S.A., Beļģija QJ01CR02 dogs; cats Vairāk

Medicinal product information

Pharmaceutical form: tablets
International name (active substance): Amoxicillin trihydrate, Potassium clavulanate
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Haupt Pharma Latina S.R.L., Itālija
Date of authorisation/renewal: 03-Dec-2009
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [PDF] Skat_sadaļā_Zāļu_apraksts (24-Apr-2023)
Labelling text: [PDF] Skat_sadaļā_Zāļu_apraksts (24-Apr-2023)
Summary of product characteristics: [DOCX] Zāļu_informācija_ZA_M_LI (24-Apr-2023)

Products

ID Strength Package size Primary packaging Labelling
V/NRP/99/1027-01 50 mg 1 Blisteris, 10 tablete -
V/NRP/99/1027-02 50 mg 10 Blisteris, 10 tablete -
Synulox 250 mg - V/NRP/09/0025 Zoetis Belgium S.A., Beļģija QJ01CR02 dogs; cats Vairāk

Medicinal product information

Pharmaceutical form: tablets
International name (active substance): Amoxicillin trihydrate, Potassium clavulanate
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Haupt Pharma Latina S.R.L., Itālija
Date of authorisation/renewal: 03-Dec-2009
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [PDF] Skat_sadaļā_Zāļu_apraksts (24-Apr-2023)
Labelling text: [PDF] Skat_sadaļā_Zāļu_apraksts (24-Apr-2023)
Summary of product characteristics: [DOCX] Zāļu_informācija_ZA_M_LI (24-Apr-2023)

Products

ID Strength Package size Primary packaging Labelling
V/NRP/09/0025-01 250 mg 1 Blisteris, 10 tablete -
V/NRP/09/0025-02 250 mg 10 Blisteris, 10 tablete -
Synulox Tabletki 250 mg - V/I/25/0042 Zoetis Belgium S.A., Beļģija QJ01CR02 dogs Vairāk

Medicinal product information

Pharmaceutical form: tablets
International name (active substance): Amoxicillin trihydrate, Potassium clavulanate
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Haupt Pharma Latina S.R.L., Itālija
Date of authorisation/renewal: 09-Jun-2025
Marketing authorisation valid until: 08-Jun-2030
Marketing authorisation procedure: I
Package leaflet: [DOCX] 09062025LI (09-Jun-2025)
Labelling text: See products section
Summary of product characteristics: -

Products

ID Strength Package size Primary packaging Labelling
V/I/25/0042-01 1 Blisteris, 10 tablete [PDF]
Synulox LC - V/I/20/0043 Zoetis Belgium S.A., Beļģija QJ51RV01 lactating cows Vairāk

Medicinal product information

Pharmaceutical form: intramammary suspension
International name (active substance): Amoxicillin trihydrate, Potassium clavulanate, Prednisolone
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Haupt Pharma Latina s.r.l., Itālija
Date of authorisation/renewal: 11-Sep-2020
Marketing authorisation valid until: 10-Sep-2025
Marketing authorisation procedure: I
Package leaflet: [DOCX] 31.05.2024 (31-May-2024)
Labelling text: See products section
Summary of product characteristics: -

Products

ID Strength Package size Primary packaging Labelling
V/I/20/0043-03 300 Injektors, 1 deva [PDF]
Synulox RTU - V/I/22/0013 Zoetis Belgium S.A., Beļģija QJ01CR02 cattle; pigs; dogs; cats Vairāk

Medicinal product information

Pharmaceutical form: suspension for injection
International name (active substance): Amoxicillin trihydrate, Potassium clavulanate
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Haupt Pharma Latina S.R.L., Itālija
Date of authorisation/renewal: 31-Mar-2022
Marketing authorisation valid until: 30-Mar-2027
Marketing authorisation procedure: I
Package leaflet: [DOCX] 22062023_LI (22-Jun-2023)
Labelling text: See products section
Summary of product characteristics: -

Products

ID Strength Package size Primary packaging Labelling
V/I/22/0013-01 1 Flakons, 100 ml [PDF] [PDF]
V/I/22/0013-02 6 Flakons, 100 ml -
Synulox Tabletki 50 mg - V/I/25/0041 Zoetis Belgium S.A., Beļģija QJ01CR02 dogs; cats Vairāk

Medicinal product information

Pharmaceutical form: tablets
International name (active substance): Amoxicillin trihydrate, Potassium clavulanate
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Haupt Pharma Latina S.R.L., Itālija
Date of authorisation/renewal: 05-Jun-2025
Marketing authorisation valid until: 04-Jun-2030
Marketing authorisation procedure: I
Package leaflet: [DOCX] 04062025LI (04-Jun-2025)
Labelling text: See products section
Summary of product characteristics: -

Products

ID Strength Package size Primary packaging Labelling
V/I/25/0041-01 1 Blisteris, 10 tablete [PDF]

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