Medicine
Wayrilz 400 mg tablet
Wayrilz 400 mg tablet is a prescription medicine containing Rilzabrutinib for oral use, marketed by Genzyme, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at room temperature between 20°C to 25°C (68°F to 77°F), excursions are…
Key facts
- Active ingredient (INN)
- Rilzabrutinib
- Brand
- Wayrilz
- Strength
- 400 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 2 blister pack, 1 bottle
- Marketing authorisation holder
- Genzyme
- Manufacturer
- Genzyme
- Origin register
- US FDA, United States
- Storage
- Store at room temperature between 20°C to 25°C (68°F to 77°F), excursions are permitted between 15°C to 30°C (59°F to 86°F). Store and dispense in the original package. Protect from light and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 August 2025
- Identifiers
- RxCUI 2722403, 2722409DailyMed set ID 95ffd367-9b0c-4f75-8487-5d8f3c0a5ad0NDC 58468-0251Application NDA219685
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
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
Clinical summary
Rilzabrutinib is a kinase inhibitor indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. It is available as tablets for oral use. MedsAcross supplies Rilzabrutinib 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 RilzabrutinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- WAYRILZ prescribing information (Genzyme) · U.S. National Library of Medicine, DailyMed
- Wayrilz: European public assessment report (EPAR) · European Medicines Agency
Need Wayrilz 400 mg tablet 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.