Veterinary medicinal product register

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Data selected by Name enroxil
Original name Strength Marketing authorisation number Marketing authorisation holder: ATCvet code Species More
Enroxil 100 mg/ml V/NRP/95/0194 KRKA, d.d., Novo mesto, Slovēnija QJ01MA90 cattle; pigs Vairāk

Medicinal product information

Pharmaceutical form: solution for injection
International name (active substance): Enrofloxacin
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release KRKA, d.d., Novo mesto, Slovēnija
Date of authorisation/renewal: 16-Dec-2010
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [PDF] Skat_sadaļā_Zāļu_apraksts (11-Oct-2023)
Labelling text: [PDF] Skat_sadaļā_Zāļu_apraksts (11-Oct-2023)
Summary of product characteristics: [PDF] Zāļu_informācija_ZA_M_LI (11-Oct-2023)

Products

ID Strength Package size Primary packaging Labelling
V/NRP/95/0194-01 100 mg/ml 1 Stikla pudelīte (brūna), 50 ml [JPG] [JPG]
V/NRP/95/0194-02 100 mg/ml 1 Stikla pudelīte (brūna), 100 ml [PDF] [PDF]
Enroxil 100 mg/ml V/NRP/96/0301 KRKA, d.d., Novo mesto, Slovēnija QJ01MA90 turkeys; chickens Vairāk

Medicinal product information

Pharmaceutical form: solution for oral use
International name (active substance): Enrofloxacin
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release KRKA, d.d., Novo mesto, Slovēnija
Date of authorisation/renewal: 15-Oct-2010
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [PDF] Skat_sadaļā_Zāļu_apraksts (01-Jul-2024)
Labelling text: [PDF] Skat_sadaļā_Zāļu_apraksts (01-Jul-2024)
Summary of product characteristics: [DOCX] Zāļu_informācija_ZA_M_LI (01-Jul-2024)

Products

ID Strength Package size Primary packaging Labelling
V/NRP/96/0301-01 100 mg/ml 1 Stikla pudelīte (brūna), 100 ml [JPG] [JPG] [JPG] [JPG]
V/NRP/96/0301-02 100 mg/ml 1 Stikla pudelīte (brūna), 1 l [JPG] [PDF] [JPG]
Enroxil 50 mg/ml V/NRP/95/0195 KRKA, d.d., Novo mesto, Slovēnija QJ01MA90 cattle; pigs; sheep; goats; dogs; calves Vairāk

Medicinal product information

Pharmaceutical form: solution for injection
International name (active substance): Enrofloxacin
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release KRKA, d.d., Novo mesto, Slovēnija
Date of authorisation/renewal: 16-Dec-2010
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [PDF] Skat_sadaļā_Zāļu_apraksts (11-Oct-2023)
Labelling text: [PDF] Skat_sadaļā_Zāļu_apraksts (11-Oct-2023)
Summary of product characteristics: [PDF] Zāļu_informācija_ZA_M_LI (11-Oct-2023)

Products

ID Strength Package size Primary packaging Labelling
V/NRP/95/0195-01 50 mg/ml 1 Stikla pudelīte (brūna), 50 ml [JPG] [JPG]
V/NRP/95/0195-02 50 mg/ml 1 Stikla pudelīte (brūna), 100 ml [PDF] [PDF] [PDF]
Enroxil Flavour 15 mg V/DCP/08/1617 KRKA, d.d., Novo mesto, Slovēnija QJ01MA90 dogs; cats Vairāk

Medicinal product information

Pharmaceutical form: tablets
International name (active substance): Enrofloxacin
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release KRKA, d.d., Novo mesto, Slovēnija
Date of authorisation/renewal: 27-Feb-2014
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: DCP
Package leaflet: [DOC] 230321LI (23-Mar-2021)
Labelling text: [DOC] 230321M (23-Mar-2021)
Summary of product characteristics: [DOCX] 230321ZA (23-Mar-2021)

Products

ID Strength Package size Primary packaging Labelling
V/DCP/08/1617-01 15 mg 100 Blisteris, 1 tablete [PDF] [JPG]
V/DCP/08/1617-02 15 mg 10 Blisteris, 1 tablete [PDF]
Enroxil Flavour 50 mg V/DCP/08/1618 KRKA, d.d., Novo mesto, Slovēnija QJ01MA90 dogs Vairāk

Medicinal product information

Pharmaceutical form: tablets
International name (active substance): Enrofloxacin
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release KRKA, d.d., Novo mesto, Slovēnija
Date of authorisation/renewal: 27-Feb-2014
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: DCP
Package leaflet: [DOCX] 230321LI (23-Mar-2021)
Labelling text: [DOC] 230321M (23-Mar-2021)
Summary of product characteristics: [DOCX] 230321ZA (23-Mar-2021)

Products

ID Strength Package size Primary packaging Labelling
V/DCP/08/1618-01 50 mg 100 Blisteris, 1 tablete [PDF] [JPG]
V/DCP/08/1618-02 50 mg 10 Blisteris, 1 tablete [PDF]
Enroxil Flavour 150 mg V/DCP/08/1619 KRKA, d.d., Novo mesto, Slovēnija QJ01MA90 dogs Vairāk

Medicinal product information

Pharmaceutical form: tablets
International name (active substance): Enrofloxacin
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release KRKA, d.d., Novo mesto, Slovēnija
Date of authorisation/renewal: 27-Feb-2014
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: DCP
Package leaflet: [DOC] 230321LI (23-Mar-2021)
Labelling text: [DOC] 230321M (23-Mar-2021)
Summary of product characteristics: [DOC] 230321ZA (23-Mar-2021)

Products

ID Strength Package size Primary packaging Labelling
V/DCP/08/1619-01 150 mg 100 Blisteris, 1 tablete [PDF] [JPG]
V/DCP/08/1619-02 150 mg 10 Blisteris, 1 tablete [PDF]

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