Veterinary medicinal product register

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Data selected by Name Oestrophan
Original name Strength Marketing authorisation number Marketing authorisation holder: ATCvet code Species More
Oestrophan inj. ad us. vet. 0.25 mg/ml V/NRP/96/0389 Bioveta, a.s., Čehija QG02AD90 sows; mares; cows Vairāk

Medicinal product information

Pharmaceutical form: solution for injection
International name (active substance): Cloprostenol
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Bioveta, a.s., Čehija
Date of authorisation/renewal: 27-May-2011
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [DOCX] 27122023_LI (27-Dec-2023)
Labelling text: [DOCX] 27122023_M (27-Dec-2023)
Summary of product characteristics: [DOCX] 27122023_ZA (27-Dec-2023)

Products

ID Strength Package size Primary packaging Labelling
V/NRP/96/0389-01 0,25 mg 10 Stikla ampula, 2 ml -
V/NRP/96/0389-02 0,25 mg 1 Stikla flakons, 10 ml -
V/NRP/96/0389-03 0,25 mg 1 Stikla flakons, 50 ml -
Oestrophan 0.25 mg/ml V/I/19/0077 Bioveta, a.s., Čehija QG02AD90 sows; mares; cows Vairāk

Medicinal product information

Pharmaceutical form: solution for injection
International name (active substance): Cloprostenol
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Bioveta, a.s., Čehija
Date of authorisation/renewal: 16-Dec-2024
Marketing authorisation valid until: 15-Dec-2029
Marketing authorisation procedure: I
Package leaflet: [DOCX] 16122024_LI (16-Dec-2024)
Labelling text: See products section
Summary of product characteristics: -

Products

ID Strength Package size Primary packaging Labelling
V/I/19/0077-01 0,25 mg 10 Stikla ampula, 2 ml [PDF] [PDF]
V/I/19/0077-02 0,25 mg 1 Stikla flakons, 10 ml [PDF] [PDF]

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