EMEA-002575-PIP03-21

Key facts

Invented name
Gavreto
Active substance
pralsetinib
Therapeutic area
Oncology
Decision number
P/0428/2021
PIP number
EMEA-002575-PIP03-21
Pharmaceutical form(s)
Capsule, hard
Condition(s) / indication(s)
  • Treatment of all conditions included in the category of malignant neoplasms [except lung cancer (small cell and non-small cell cancer), thyroid neoplasms, central nervous system tumours, haematopoietic and lymphoid tissue neoplasms]
  • Treatment of malignant neoplasms of haematopoietic and lymphoid tissue
  • Treatment of malignant neoplasms of the central nervous system
Route(s) of administration
Oral use
Contact for public enquiries
Roche Registration GmbH

E-mail: global.paediatrics@roche.com
Tel. +41 61 687 9411

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

Decision

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