Drovelis

Medicinal product

(Invented) name

Drovelis

Active substance (s)

Drospirenonas/Estetrolis

Strength

3 mg/14,2 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03AA18, drospirenone and estetrol

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2021-05-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Drospirenonas	3 mg
Estetrolis	14,2 mg
White tablet (placebo)	1 vnt.

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
106568	92670	1092670	lizdinė plokštelė	N28 (1x28)		Receptinis	EU/1/21/1547/001	Tiekiama	-	-	No	-	-
106569	92671	1092671	lizdinė plokštelė	N84 (3×28)		Receptinis	EU/1/21/1547/002	Netiekiama	-	-	No	-	-
106570	92672	1092672	lizdinė plokštelė	N168 (6×28)		Receptinis	EU/1/21/1547/003	Netiekiama	-	-	No	-	-
106571	92673	1092673	lizdinė plokštelė	N364 (13×28)		Receptinis	EU/1/21/1547/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-05-19	Registruotas