Key facts

Invented name
  • Vargatef; Ofev
    • Vargatef
    • Ofev
Active Substance
nintedanib
Therapeutic area
Oncology
Decision number
P/0124/2017
PIP number
EMEA-001006-PIP03-16
Pharmaceutical form(s)
Capsule (soft)
Condition(s) / indication(s)
  • Treatment of lung carcinoma (small cell and non-small cell carcinoma)
  • Treatment of mesothelioma
Route(s) of administration
Oral use
Contact for public enquiries

Boehringer Ingelheim International GmbH

Tel. +49 6132 778271
Email: Paediatrics@boehringer-ingelheim.com

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

Decision

P/0124/2017: EMA decision of 5 May 2017 on the granting of a product-specific waiver for nintedanib (Vargatef, Ofev), (EMEA-001006-PIP03-16)

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