Zoely

Medicinal product

(Invented) name

Zoely

Active substance (s)

Nomegestrolio acetatas/Estradiolis

Strength

2,5 mg/1,5 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)

G03AA14, Nomegestrol and estradiol

Marketing authorisation holder

Theramex Ireland Limited, Airija

Date of authorisation

2011-07-27

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Nomegestrolio acetatas	2,5 mg
Estradiolis	1,5 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
47814	61636	1061636	lizdinė plokštelė	N28 (24+4 placebo)		Receptinis	EU/1/11/690/001	Tiekiama	-	-	No	-	-
47815	61637	1061637	lizdinė plokštelė	N3x28 (24+4 placebo)		Receptinis	EU/1/11/690/002	Netiekiama	-	-	No	-	-
54579	68576	1068576	lizdinė plokštelė	N168 (144+24 placebo)		Receptinis	EU/1/11/690/003	Netiekiama	-	-	No	-	-
54580	68577	1068577	lizdinė plokštelė	N364 (312+52 placebo)		Receptinis	EU/1/11/690/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-07-27	Registruotas