EMEA-000411-PIP01-08

Adopted

First published: 22/10/2009
Last updated: 22/10/2009
EMEA/492918/2009

Active substance	mifepristone misoprostol
Therapeutic area	Endocrinology-Gynaecology-Fertility-Metabolism
Decision number	P/156/2009
PIP number	EMEA-000411-PIP01-08
Pharmaceutical form(s)	Tablet
Condition(s) / indication(s)	Medical Abortion
Route(s) of administration	Oral use Vaginal use
Contact for public enquiries	Sun Pharmaceutical Industries Europe B.V. E-mail: secretary.netherlands@sunpharma-europe.com Country: Netherlands Phone: +31 235685501 Fax: +31 235685505
Decision type	W: decision granting a waiver in all age groups for all conditions or indications