EMEA-002428-PIP02-18

Adopted

First published: 21/11/2019
EMA/444283/2019

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