Medicine
Imcivree 10 mg/1 mL injection
Imcivree 10 mg/1 mL injection is a prescription medicine containing Setmelanotide for subcutaneous use, marketed by Rhythm 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 unopened IMCIVREE vials in the refrigerator at 2°C to 8°C (36°F to 46°F)…
Key facts
- Active ingredient (INN)
- Setmelanotide
- Brand
- Imcivree
- Strength
- 10 mg/1 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 vial of 1 mL
- Marketing authorisation holder
- Rhythm Pharmaceuticals
- Manufacturer
- Rhythm Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store unopened IMCIVREE vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. After removal from the refrigerator, vials may be kept at temperatures ranging from refrigerated to room temperature (2°C to 25°C [36°F to 77°F]) for up to 30 days with brief excursions up to 30°C (86°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A08AA Anorectic
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 December 2020
- Identifiers
- RxCUI 2469346, 2469351DailyMed set ID 70c3ccf7-4df0-4c75-ba07-fede9970c8d9NDC 72829-010Application NDA213793
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, multi-dose in 1 carton / 1 mL in 1 vial, multi-dose | 72829-010-01 | Rhythm Pharmaceuticals | 14 December 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
Clinical summary
Setmelanotide is a melanocortin 4 receptor agonist indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged, among other approved uses. It is available as injection for subcutaneous use. MedsAcross supplies Setmelanotide 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 SetmelanotideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Imcivree prescribing information (Rhythm Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Imcivree: European public assessment report (EPAR) · European Medicines Agency
Need Imcivree 10 mg/1 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.