VITRAKVI Oral solution Ref.[10645] Active ingredients: Larotrectinib

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Bayer AG, 51368 Leverkusen, Germany

Product name and form

VITRAKVI 20 mg/mL oral solution.

Pharmaceutical Form

Oral solution.

Clear yellow to orange solution.

Qualitative and quantitative composition

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
Sucrose
Hydroxypropylbetadex
Glycerol (E422)
Sorbitol (E420)
Sodium citrate (E331)
Sodium dihydrogen phosphate dihydrate (E339)
Citric acid (E330)
Propylene glycol (E1520)
Potassium sorbate (E202)
Methyl parahydroxybenzoate (E218)
Citrus fruit flavour
Natural flavour

Pack sizes and marketing

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.

Marketing authorization holder

Bayer AG, 51368 Leverkusen, Germany

Marketing authorization dates and numbers

EU/1/19/1385/003 – VITRAKVI 20 mg/mL oral solution

Date of first authorisation: 19 September 2019

Drugs

Drug Countries
VITRAKVI Austria, Brazil, Canada, Estonia, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, Poland, Turkey, United Kingdom, United States

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