Medicine
Empaveli 1080 mg/20 mL injection
Empaveli 1080 mg/20 mL injection is a prescription medicine containing Pegcetacoplan for subcutaneous use, marketed by Apellis 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 vials of EMPAVELI refrigerated at 2°C to 8°C (36°F to 46°F) in the…
Key facts
- Active ingredient (INN)
- Pegcetacoplan
- Brand
- Empaveli
- Strength
- 1080 mg/20 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 vial of 20 mL
- Marketing authorisation holder
- Apellis Pharmaceuticals
- Manufacturer
- Apellis Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store vials of EMPAVELI refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AJ03 Pegcetacoplan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 May 2021
- Identifiers
- RxCUI 2557386, 2557391DailyMed set ID c23d89e9-b00b-4520-e053-2995a90a95afNDC 73606-010Application NDA215014
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 in 1 carton / 20 mL in 1 vial | 73606-010-01 | Apellis Pharmaceuticals | 14 May 2021 |
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 Pegcetacoplan
Clinical summary
Pegcetacoplan is a complement inhibitor indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), among other approved uses. It is available as injection for intravitreal and subcutaneous use. MedsAcross supplies Pegcetacoplan 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 PegcetacoplanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Empaveli prescribing information (Apellis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Aspaveli: European public assessment report (EPAR) · European Medicines Agency
Need Empaveli 1080 mg/20 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.