/EMA/PE/0000235924
NEWS

EMA/PE/0000235924

EMA
2026/07/14

Key facts

Active substance

Mitazalimab

Therapeutic area

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

Decision number

EMA/PE/0000235924

PIP number

EMA/PE/0000235924

Pharmaceutical form(s)

All pharmaceutical forms

Condition(s) / indication(s)

Treatment of pancreatic cancer

Route(s) of administration

All routes of administration

Contact for public enquiries

Alligator Bioscience AB E-mail: [email protected] Tel: +46 46 540 82 00

Decision type

P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision date

16/05/2025

Compliance check done

No

Decision

EMA/PE/0000235924 : EMA decision of 16 May 2025 on the granting of a product specific waiver for mitazalimab

Adopted

Reference Number:

EMADOC-1700519818-2114084

English (EN) (238.66 KB - PDF)

First published:

14/07/2026

View

Summary

EMA/PE/0000235924