EMEA-001768-PIP02-15-M03 - paediatric investigation plan

rolapitant
PIPHuman

Key facts

Invented name
  • Varuby
  • Varuby
Active Substance
rolapitant
Therapeutic area
Haematology-Hemostaseology
Decision number
P/0194/2020
PIP number
EMEA-001768-PIP02-15-M03
Pharmaceutical form(s)
  • Film-coated tablet
  • Age appropriate oral dosage formulation
Condition(s) / indication(s)
Prevention of nausea and vomiting
Route(s) of administration
Oral use
Contact for public enquiries

Tesaro Bio Netherlands B.V.

Tel. +41 415880618
E-mail: lenerose.x.arfelt@gsk.com

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

Decision

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