Medicine
Gazyva 1000 mg/40 mL injection
Gazyva 1000 mg/40 mL injection is a prescription medicine containing Obinutuzumab for intravenous use, marketed by Genentech, 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
Store at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE. Protect from light. DO NOT…
Key facts
- Active ingredient (INN)
- Obinutuzumab
- Brand
- Gazyva
- Strength
- 1000 mg/40 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 40 mL
- Marketing authorisation holder
- Genentech
- Manufacturer
- Genentech
- Origin register
- US FDA, United States
- Storage
- Store at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE. Protect from light. DO NOT SHAKE.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01FA03 Obinutuzumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 November 2013
- Identifiers
- RxCUI 1442693, 1442698DailyMed set ID df12ceb2-5b4b-4ab5-a317-2a36bf2a3cdaNDC 50242-070Application BLA125486
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 |
|---|---|---|---|
| 1 vial, single-use in 1 carton / 40 mL in 1 vial, single-use | 50242-070-01 | Genentech | 1 November 2013 |
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
Obinutuzumab is a CD20-directed cytolytic antibody indicated in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL), among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Obinutuzumab 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 ObinutuzumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Gazyva prescribing information (Genentech) · U.S. National Library of Medicine, DailyMed
- Gazyvaro: European public assessment report (EPAR) · European Medicines Agency
Need Gazyva 1000 mg/40 mL injection 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.