Medicine
Imaavy 299.7 mg/1.62 mL injection
Imaavy 299.7 mg/1.62 mL injection is a prescription medicine containing Nipocalimab for intravenous use, marketed by Janssen Biotech, 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 2 ºC to 8 ºC (36 ºF to 46 ºF) in the original…
Key facts
- Active ingredient (INN)
- Nipocalimab
- Brand
- Imaavy
- Strength
- 299.7 mg/1.62 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 1.62 mL
- Marketing authorisation holder
- Janssen Biotech
- Manufacturer
- Janssen Biotech
- Origin register
- US FDA, United States
- Storage
- Store vials refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF) in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Diluted Solution For storage of the diluted IMAAVY solution, see Dosage and Administration.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AL03 Nipocalimab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 April 2025
- Identifiers
- RxCUI 2712699, 2712706, 2712708 +1DailyMed set ID 8886274c-f2b2-48af-85c1-2f90bfe304b8NDC 57894-800Application BLA761430
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-dose in 1 box / 1.62 mL in 1 vial, single-dose | 57894-800-01 | Janssen Biotech | 29 April 2025 |
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 Nipocalimab
Clinical summary
Nipocalimab is a prescription medicine indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. MedsAcross supplies Nipocalimab 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 NipocalimabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- IMAAVY prescribing information (Janssen Biotech) · U.S. National Library of Medicine, DailyMed
- Imaavy: European public assessment report (EPAR) · European Medicines Agency
Need Imaavy 299.7 mg/1.62 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.