Medicine
Spevigo 300 mg/2 mL injection
Spevigo 300 mg/2 mL injection is a prescription medicine containing Spesolimab for subcutaneous use, marketed by LEO Pharma, 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 SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to…
Key facts
- Active ingredient (INN)
- Spesolimab
- Brand
- Spevigo
- Strength
- 300 mg/2 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 2 mL, 2 syringes of 2 mL
- Marketing authorisation holder
- LEO Pharma
- Manufacturer
- LEO Pharma
- Origin register
- US FDA, United States
- Storage
- Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. If needed, SPEVIGO 300 mg/2 mL prefilled syringes may be stored at room temperature up to a maximum of 25°C (77°F) for up to 14 days 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
- L04AC22 Spesolimab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 March 2026
- Identifiers
- RxCUI 2610422, 2610428, 2678979 +3DailyMed set ID 78a4f7eb-8d34-4467-8d40-74ed24323806NDC 50222-362Application BLA761244
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 syringe, glass in 1 carton / 2 mL in 1 syringe, glass | 50222-362-01 | LEO Pharma | 9 March 2026 |
| 2 syringe, glass in 1 carton / 2 mL in 1 syringe, glass | 50222-362-02 | LEO Pharma | 9 March 2026 |
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 Spesolimab
Clinical summary
Spesolimab is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. MedsAcross supplies Spesolimab 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 SpesolimabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SPEVIGO prescribing information (Boehringer Ingelheim Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Spevigo: European public assessment report (EPAR) · European Medicines Agency
Need Spevigo 300 mg/2 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.