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Medicine

Proleukin 1.1 mg/mL powder for injection

Aldesleukin · Intravenous · Iovance Biotherapeutics
Available on requestPrescription onlyUS FDA Cold chain

Proleukin 1.1 mg/mL powder for injection is a prescription medicine containing Aldesleukin for intravenous use, marketed by Iovance Biotherapeutics, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Store unopened vials refrigerated at 2° to 8°C (36° to 46°F) in the original…

Key facts

Active ingredient (INN)
Aldesleukin
Brand
Proleukin
Strength
1.1 mg/mL
Dosage form
Powder for injection
Route
Intravenous
Packs
1 vial
Marketing authorisation holder
Iovance Biotherapeutics
Manufacturer
Iovance Biotherapeutics
Origin register
US FDA, United States
Storage
Store unopened vials refrigerated at 2° to 8°C (36° 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
L03AC01 Aldesleukin
HS code (indicative)
3002.15Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
5 May 1992
Identifiers
RxCUI 105648, 307816DailyMed set ID f3c516ad-d405-4fbe-af6a-962080dbfa7dNDC 73776-022Application BLA103293

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

PackCodeLabelerMarketed since
1 vial, single-dose in 1 carton / 1 mL in 1 vial, single-dose73776-022-01Iovance Biotherapeutics15 July 2024

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 5 May 1992Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

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

Aldesleukin is a lymphocyte growth factor indicated for the treatment of adults with metastatic renal cell carcinoma, among other approved uses. It is available as powder for injection for intravenous use. MedsAcross supplies Aldesleukin 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 Aldesleukin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Proleukin 1.1 mg/mL powder for 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.