EMEA-002798-PIP04-23 - paediatric investigation plan

Key facts

Active Substance: retifanlimab
Therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Decision number: P/0532/2023
PIP number: EMEA-002798-PIP04-23
Pharmaceutical form(s): All pharmaceutical forms
Condition(s) / indication(s): Treatment of lung cancer
Route(s) of administration: All routes of administration
Contact for public enquiries: Incyte Biosciences Distribution B.V.
E-mail: RA@incyte.com
Tel. +1 3024252734
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Decision date: 29/12/2023

P/0532/2023: EMA decision of 29 December 2023 on the granting of a product specific waiver for retifanlimab (EMEA-002798-PIP04-23)

Reference Number: EMA/517071/2023

English (EN) (193.55 KB - PDF)

First published: 13/02/2025