EMEA-001596-PIP02-17

Key facts

Invented name
Giotrif
Active substance
afatinib
Therapeutic area
Oncology
Decision number
P/0320/2018
PIP number
EMEA-001596-PIP02-17
Pharmaceutical form(s)
Oral use
Condition(s) / indication(s)
  • Treatment of all conditions included in the category of malignant neoplasms (excluding central nervous system, haematopoietic and lymphoid tissue neoplasms)
  • Treatment of malignant neoplasms of the central nervous system
Route(s) of administration
  • Film-coated tablet
  • Capsules and solvent for oral solution
Contact for public enquiries
Boehringer Ingelheim International GmbH

Tel. +49 6132 778271
E-mail: paediatrics@boehringer-ingelheim.com

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

Decision

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