Medicine
Scenesse 16 mg/16 mg implant
Scenesse 16 mg/16 mg implant is a prescription medicine containing Afamelanotide for subcutaneous use, marketed by Clinuvel, 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 in a refrigerator at 2°C – 8°C (36°F-46°F). Protect from light.
Key facts
- Active ingredient (INN)
- Afamelanotide
- Brand
- Scenesse
- Strength
- 16 mg/16 mg
- Dosage form
- Implant
- Route
- Subcutaneous
- Packs
- 1 vial
- Marketing authorisation holder
- Clinuvel
- Manufacturer
- Clinuvel
- Origin register
- US FDA, United States
- Storage
- Store in a refrigerator at 2°C – 8°C (36°F-46°F). Protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D02BB02 Afamelanotide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 December 2019
- Identifiers
- RxCUI 2262254, 2262259DailyMed set ID 94f53286-11dd-7fbb-e053-2a95a90a7c48NDC 73372-0116Application NDA210797
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 / 1 mg in 1 vial, glass | 73372-0116-1 | Clinuvel | 31 December 2019 |
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
Afamelanotide is a prescription medicine indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). It is available as implants for subcutaneous use. MedsAcross supplies Afamelanotide 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 AfamelanotideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SCENESSE prescribing information (Clinuvel) · U.S. National Library of Medicine, DailyMed
- Scenesse: European public assessment report (EPAR) · European Medicines Agency
Need Scenesse 16 mg/16 mg implant 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.