Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: EUSA Pharma (Netherlands) B.V., Johannes Vermeerplein 11, 1071 DV, Amsterdam, Netherlands
Fotivda 890 microgram hard capsules.
Fotivda 1340 microgram hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Fotivda 890 microgram hard capsules: Hard capsule with dark blue opaque cap and bright yellow opaque body, printed with yellow ink “TIVZ” on the cap and with dark blue ink “LD” on the body. Fotivda 1340 microgram hard capsules: Hard capsule with bright yellow opaque cap and bright yellow opaque body, printed with dark blue ink “TIVZ” on the cap and with dark blue ink “SD” on the body. |
Fotivda 890 microgram hard capsules: Each hard capsule contains tivozanib hydrochloride monohydrate equivalent to 890 microgram tivozanib.
Excipients with known effect: Each hard capsule contains trace amounts of tartrazine (E102) (8-12% of the yellow printing ink composition) (see section 4.4).
Fotivda 1340 microgram hard capsules: Each hard capsule contains tivozanib hydrochloride monohydrate equivalent to 1340 microgram tivozanib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tivozanib |
Tivozanib potently and selectively blocks all 3 Vascular Endothelial Growth Factor receptors (VEGFR) and has been shown to block various VEGF-induced biochemical and biologic responses in vitro. By blocking VEGF-induced VEGFR activation, tivozanib inhibits angiogenesis and vascular permeability in tumour tissues, leading to inhibition of tumour growth in vivo. |
| List of Excipients |
|---|
Fotivda 890 microgram hard capsulesCapsule content: Mannitol Capsule shell: Gelatin Printing ink (yellow): Shellac Printing ink (blue): Shellac Fotivda 1340 microgram hard capsulesCapsule content: Mannitol Capsule shell: Gelatin Printing ink (blue): Shellac |
White HDPE bottle with a child resistant closure containing 21 hard capsules.
Each pack contains 1 bottle.
EUSA Pharma (Netherlands) B.V., Johannes Vermeerplein 11, 1071 DV, Amsterdam, Netherlands
Fotivda 890 microgram hard capsules: EU/1/17/1215/001
Fotivda 1340 microgram hard capsules: EU/1/17/1215/002
24/08/2017
| Drug | Countries | |
|---|---|---|
| FOTIVDA | Austria, Estonia, Spain, Finland, Croatia, Ireland, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom |
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