Edrocont

Medicinal product

(Invented) name

Edrocont

Active substance (s)

Drospirenonas/Etinilestradiolis

Strength

3000 µg/30 µg

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)

G03AA12, Drospirenone and ethinylestradiol

Marketing authorisation holder

Heaton k.s., Čekija

Date of authorisation

2024-09-25

Date of renewal

Documents

LT_216 Edrocont_SD+Summ+LT apzvalga.pdf

5587 Edrocont RPP 2025 06 05.docx

5587 Pakuotės lapelis 2025 06 05.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0216/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Drospirenonas	3000 µg
Etinilestradiolis	30 µg

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
115170	101279	1101279	lizdinė plokštelė	N1×21		Receptinis	LT/1/24/5587/001	Netiekiama	-	-	No	-	-
115171	101280	1101280	lizdinė plokštelė	N3×21		Receptinis	LT/1/24/5587/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-25	Registruotas