EMA/PE/0000237903

Key facts

Active substance

padeliporfin di-potassium

Therapeutic area

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Decision number

EMA/PE/0000237903

PIP number

EMA/PE/0000237903

Pharmaceutical form(s)

Powder for solution for injection

Condition(s) / indication(s)

Treatment of upper tract urothelial cancer

Route(s) of administration

Intravenous use

Contact for public enquiries

Steba Biotech S.A. E-mail: [email protected] Tel: +33 687 603 258

Decision type

W: decision granting a waiver in all age groups for all conditions or indications

Decision date

16/04/2025

Compliance check done

No

Decision

EMA/PE/0000237903 : EMA decision of 16 April 2025 on the granting of a product specific waiver for padeliporfin (dipotassium)

Adopted

Reference Number:

EMADOC-1700519818-2008916

English (EN) (218.74 KB - PDF)

First published:

03/07/2026

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