Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Bayer AG, 51368 Leverkusen, Germany
VITRAKVI 20 mg/mL oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Clear yellow to orange solution. |
Each mL of oral solution contains larotrectinib sulfate equivalent to 20 mg of larotrectinib.
Excipients with known effect: Each mL of oral solution contains 295 mg sucrose, 22 mg sorbitol, 1.2 mg propylene glycol and 0.2 mg methyl parahydroxybenzoate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Larotrectinib |
Larotrectinib is an adenosine triphosphate (ATP)-competitive and selective tropomyosin receptor kinase (TRK) inhibitor. The TRK family of proteins, TRKA, TRKB, and TRKC, is encoded by NTRK1, NTRK2 and NTRK3 genes. Larotrectinib was rationally designed to avoid activity with off-target kinases. It is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. |
| List of Excipients |
|---|
|
Purified water |
Amber glass (type III) bottle with a child-resistant polypropylene (PP) cap with a polyethylene (PE) seal liner.
Each carton contains one bottle of 100 mL oral solution.
Bayer AG, 51368 Leverkusen, Germany
EU/1/19/1385/003 – VITRAKVI 20 mg/mL oral solution
Date of first authorisation: 19 September 2019
| Drug | Countries | |
|---|---|---|
| VITRAKVI | Austria, Brazil, Canada, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Turkey, United Kingdom, United States |
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