Medicine
Rystiggo 280 mg/2 mL injection
Rystiggo 280 mg/2 mL injection is a prescription medicine containing Rozanolixizumab for subcutaneous use, marketed by UCB, 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 vials refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton…
Key facts
- Active ingredient (INN)
- Rozanolixizumab
- Brand
- Rystiggo
- Strength
- 280 mg/2 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 vial of 2 mL
- Marketing authorisation holder
- UCB
- Manufacturer
- UCB
- Origin register
- US FDA, United States
- Storage
- Store vials refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light until the time of use. Do not freeze. Once a vial has been stored at room temperature, it should not be returned to the refrigerator. If needed, vials may be stored at room temperature up to 77°F (25°C) for a single period of up to 20 days in the original carton to protect the vial from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AL02 Rozanolixizumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 June 2023
- Identifiers
- RxCUI 2642288, 2642294, 2685614 +5DailyMed set ID 3c0eb8c2-c042-4954-b451-3baa77f5e6d1NDC 50474-980Application BLA761286
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 / 2 mL in 1 vial, glass | 50474-980-79 | UCB | 11 July 2023 |
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 Rozanolixizumab
Clinical summary
Rozanolixizumab is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. MedsAcross supplies Rozanolixizumab 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 RozanolixizumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- RYSTIGGO prescribing information (UCB) · U.S. National Library of Medicine, DailyMed
- Rystiggo: European public assessment report (EPAR) · European Medicines Agency
Need Rystiggo 280 mg/2 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.