EMEA-001971-PIP03-18

Key facts

Invented name
Vitrakvi
Active substance
Larotrectinib
Therapeutic area
Oncology
Decision number
P/0401/2019
PIP number
EMEA-001971-PIP03-18
Pharmaceutical form(s)
  • Capsule, hard
  • Oral solution
Condition(s) / indication(s)
Treatment of malignant neoplasms of the central nervous system
Route(s) of administration
  • Oral use
  • Nasogastric use
Contact for public enquiries
Bayer AG

Tel. +49 3046815333
E-mail: pediatrics.medical-affairs-europe@bayer.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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