EMEA-002292-PIP01-17 - paediatric investigation plan

Rovalpituzumab tesirine

Key facts

• Active Substance:
  Rovalpituzumab tesirine
• Therapeutic area:
  Oncology
• Decision number:
  P/0116/2018
• PIP number:
  EMEA-002292-PIP01-17
• Pharmaceutical form(s):
  Powder and solvent for concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of lung carcinoma (small cell and non-small cell carcinoma)
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  11/04/2018

Decision

P/0116/2018: EMA decision of 11 April 2018 on the granting of a product specific waiver for rovalpituzumab tesirine (EMEA-002292-PIP01-17)

AdoptedReference Number: EMA/197915/2018