MHRA-102249-PIP01-25-M01 (update)

Key Facts

Active Substance
  • ESTETROL MONOHYDRATE
  • DROSPIRENONE
Invented Name
  • Drovelis
  • Nextstellis
  • Lydisilka
  • Nextstellis
  • Drovelis, Lydisilka
PIP Number MHRA-102249-PIP01-25-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Prevention of pregnancy
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-102249-PIP01-25-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ESTETROL MONOHYDRATEDROSPIRENONE.pdf
Published Date 16/07/2026