Medicine
Ultomiris 300 mg/3 mL injection
Ultomiris 300 mg/3 mL injection is a prescription medicine containing Ravulizumab for intravenous use, marketed by Alexion 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
Store ULTOMIRIS vials refrigerated at 2°C to 8°C (36°F to 46°F) in the…
Key facts
- Active ingredient (INN)
- Ravulizumab
- Brand
- Ultomiris
- Strength
- 300 mg/3 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 3 mL
- Marketing authorisation holder
- Alexion Pharmaceuticals
- Manufacturer
- Alexion Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store ULTOMIRIS vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. Refer to Dosage and Administration for information on the stability and storage of diluted solutions of ULTOMIRIS.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AA43 Ravulizumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 October 2020
- Identifiers
- DailyMed set ID a9a590d9-0217-43c7-908d-e62a71279791NDC 25682-025Application BLA761108
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, glass in 1 carton / 3 mL in 1 vial, glass | 25682-025-01 | Alexion Pharmaceuticals | 9 October 2020 |
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 Ravulizumab
Clinical summary
Ravulizumab is a complement inhibitor indicated for the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH), among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Ravulizumab 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 RavulizumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ultomiris prescribing information (Alexion Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Ultomiris: European public assessment report (EPAR) · European Medicines Agency
Need Ultomiris 300 mg/3 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.