MIDIANA

Medicinal product

(Invented) name

MIDIANA

Active substance (s)

Drospirenonas/Etinilestradiolis

Strength

3 mg/0,03 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)

G03AA12, Drospirenone and ethinylestradiol

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2010-04-16

Date of renewal

2015-06-16

Documents

1957 Pakuotės lapelis 2023 01 30.docx

1957 MIDIANA PCS PL 2023 01 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HU/H/0233/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Drospirenonas	3 mg
Etinilestradiolis	0,03 mg

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
34059	36416	1036416	lizdinė plokštelė	N1x21		Receptinis	LT/1/10/1957/001	Tiekiama	-	-	No	-	-	Download
40621	54358	1054358	lizdinė plokštelė	N3x21		Receptinis	LT/1/10/1957/002	Netiekiama	-	-	No	-	-
40622	54359	1054359	lizdinė plokštelė	N6x21		Receptinis	LT/1/10/1957/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-06-16	Perregistruotas
2010-04-16	Registruotas