Esmya

Medicinal product

(Invented) name

Esmya

Active substance (s)

Ulipristalio acetatas

Strength

5 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03AD02, Ulipristal

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2012-02-23

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tablet	1 vnt.
Ulipristalio acetatas	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
51311	65205	1065205	lizdinė plokštelė	N28 (Al/PVC/PE/PVDC)		Receptinis	EU/1/12/750/001	Netiekiama	-	-	No	-	-
54706	68705	1068705	lizdinė plokštelė	N84 (Al/PVC/PE/PVDC)		Receptinis	EU/1/12/750/002	Netiekiama	-	-	No	-	-
60882	75188	1075188	lizdinė plokštelė	N30 (Al/PVC/PE/PVDC)		Receptinis	EU/1/12/750/003	Netiekiama	-	-	No	-	-
60883	75189	1075189	lizdinė plokštelė	N28 (Al/PVC/PVDC)		Receptinis	EU/1/12/750/004	Netiekiama	-	-	No	-	-
60884	75190	1075190	lizdinė plokštelė	N84 (Al/PVC/PVDC)		Receptinis	EU/1/12/750/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-30	Išregistruotas
2012-02-23	Registruotas