EMEA-003599-PIP01-24 - paediatric investigation plan

trastuzumab-exatecan derivative antibody-drug conjugate
PIPHuman

Key facts

Active Substance
trastuzumab-exatecan derivative antibody-drug conjugate
Therapeutic area
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Decision number
P/0270/2024
PIP number
EMEA-003599-PIP01-24
Pharmaceutical form(s)
All pharmaceutical forms
Condition(s) / indication(s)
  • Treatment of breast cancer
  • Treatment of endometrial cancer
Route(s) of administration
All routes of administration
Contact for public enquiries

BioNTech SE
E-mail: service@biontech.de 
Tel: +49 (0) 6131 90840

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

Decision

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