Medicine
Koselugo 25 mg capsule
Koselugo 25 mg capsule is a prescription medicine containing Selumetinib for oral use, marketed by AstraZeneca 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
KOSELUGO Oral Granules Store and transport KOSELUGO oral granules refrigerated…
Key facts
- Active ingredient (INN)
- Selumetinib
- Brand
- Koselugo
- Strength
- 25 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 28 capsules, 60 capsules
- Marketing authorisation holder
- AstraZeneca Pharmaceuticals
- Manufacturer
- AstraZeneca Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- KOSELUGO Oral Granules Store and transport KOSELUGO oral granules refrigerated at 2°C to 8°C (36°F to 46°F). Store KOSELUGO capsules at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F). After receipt, patients may store at room temperature 20°C to 25°C (68°F to 77°F). Do NOT exceed 30°C (86°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01EE04 Selumetinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 April 2020
- Identifiers
- RxCUI 2289418, 2289424, 2289426 +5DailyMed set ID 7d042c61-f28f-4ab5-ab10-d7558c0d49ffNDC 0310-0625Application NDA213756
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 |
|---|---|---|---|
| 28 capsule in 1 bottle | 0310-0625-28 | AstraZeneca Pharmaceuticals | 11 June 2021 |
| 60 capsule in 1 bottle | 0310-0625-60 | AstraZeneca Pharmaceuticals | 16 April 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
Other strengths and forms of Selumetinib
Clinical summary
Selumetinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). MedsAcross supplies Selumetinib 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 SelumetinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- KOSELUGO prescribing information (AstraZeneca Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Koselugo: European public assessment report (EPAR) · European Medicines Agency
Need Koselugo 25 mg capsule 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.