Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Bayer AG, 51368 Leverkusen, Germany
VITRAKVI 25 mg hard capsules.
VITRAKVI 100 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). VITRAKVI 25 mg hard capsules: White opaque hard gelatine capsule, size 2 (18 mm long x 6 mm wide), with blue printing of BAYER-cross and “LARO 25 mg” on body of capsule. VITRAKVI 100 mg hard capsules: White opaque hard gelatine capsule, size 0 (22 mm long x 7 mm wide), with blue printing of BAYER-cross and “LARO 100 mg” on body of capsule. |
VITRAKVI 25 mg hard capsules: Each hard capsule contains larotrectinib sulfate equivalent to 25 mg of larotrectinib.
VITRAKVI 100 mg hard capsules: Each hard capsule contains larotrectinib sulfate equivalent to 100 mg of larotrectinib.
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 |
|---|
|
Capsule shell: Gelatin Printing ink: Shellac |
High density polyethylene (HDPE)-bottles with a child-resistant polypropylene (PP) cap with a polyethylene (PE) heat seal layer.
Each carton contains one bottle of 56 hard capsules.
Bayer AG, 51368 Leverkusen, Germany
EU/1/19/1385/001 – VITRAKVI 25 mg
EU/1/19/1385/002 – VITRAKVI 100 mg
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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