EMEA-002428-PIP02-18

Key facts

Active substance
  • Relugolix
  • estradiol
  • norethisterone acetate
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/0278/2019
PIP number
EMEA-002428-PIP02-18
Pharmaceutical form(s)
Tablet
Condition(s) / indication(s)
Treatment of endometriosis
Route(s) of administration
Oral use
Contact for public enquiries
Myovant Sciences Ireland Limited

Tel.+1 6502380250
E-mail: PIPrelugolix@myovant.com

Decision type
RP: decision refers to a refusal on a proposed Paediatric Investigation Plan

Decision

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