Medicine
Vitrakvi 100 mg capsule
Vitrakvi 100 mg capsule is a prescription medicine containing Larotrectinib for oral use, marketed by Bayer HealthCare Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
One bottle containing 100 mL NDC# 50419-392-01 Refrigerate oral solution at…
Key facts
- Active ingredient (INN)
- Larotrectinib
- Brand
- Vitrakvi
- Strength
- 100 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 60 capsules
- Marketing authorisation holder
- Bayer HealthCare Pharmaceuticals
- Manufacturers
- Bayer HealthCare PharmaceuticalsLoxo Oncology
- Origin register
- US FDA, United States
- Storage
- One bottle containing 100 mL NDC# 50419-392-01 Refrigerate oral solution at 2°C to 8°C (36°F to 46°F). Do not freeze. Two bottles each containing 50 mL NDC# 50419-393-03 Refrigerate oral solution at 2°C to 8°C (36°F to 46°F). Do not freeze. Store capsules at room temperature 20°C to 25°C (68°F to 77°F), temperature excursions between 15°C and 30°C (59°F to 86°F) are permitted.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XE53 Larotrectinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 November 2018
- Identifiers
- RxCUI 2105633, 2105645, 2105649 +3DailyMed set ID 0c8ca614-58b2-4aa4-83d3-0387a8f782fd, 9525f887-a055-4e33-8e92-898d42828cd1NDC 50419-391, 71777-391Application NDA210861
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 capsule in 1 bottle | 50419-391-01 | Bayer HealthCare Pharmaceuticals | 26 July 2019 |
| 60 capsule in 1 bottle | 71777-391-01 | Loxo Oncology | 26 November 2018 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Larotrectinib
Clinical summary
Larotrectinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation. MedsAcross supplies Larotrectinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about LarotrectinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VITRAKVI prescribing information (Bayer HealthCare Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Vitrakvi: European public assessment report (EPAR) · European Medicines Agency
Need Vitrakvi 100 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.