EMEA-001332-PIP01-12-M04

Table of contents

Key facts

Active substance
  • Estetrol
  • drospirenone
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/0478/2020
PIP number
EMEA-001332-PIP01-12-M04
Pharmaceutical form(s)
Film-coated tablet
Condition(s) / indication(s)
Prevention of pregnancy
Route(s) of administration
Oral use
Contact for public enquiries
Estetra SPRL

Tel. +32 (0)4 349 28 22
Email: estetra.regulatory@mithra.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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