EMEA-001350-PIP02-13-M04

Key facts

Invented name
Zydelig
Active substance
Idelalisib
Therapeutic area
Oncology
Decision number
P/0345/2018
PIP number
EMEA-001350-PIP02-13-M04
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate dispersible tablet
Condition(s) / indication(s)
Treatment of mature B-cell neoplasms
Route(s) of administration
Oral use
Contact for public enquiries
Gilead Sciences International Limited

Tel. +44 (0)1223 897300
E-mail: regulatory.pip@gilead.com

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

Decision

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