Ulipristal Acetate Gedeon Richter

Medicinal product

(Invented) name

Ulipristal Acetate Gedeon Richter

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)

G03XB02, Ulipristal

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2018-08-27

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10c

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
100094	86202	1086202	lizdinė plokštelė	N28 (alu/PVC/PE/PVDC)		Receptinis	EU/1/18/1309/001	Netiekiama	-	-	No	-	-
100095	86203	1086203	lizdinė plokštelė	N84 (alu/PVC/PE/PVDC)		Receptinis	EU/1/18/1309/002	Netiekiama	-	-	No	-	-
100096	86204	1086204	lizdinė plokštelė	N30 (alu/PVC/PE/PVDC)		Receptinis	EU/1/18/1309/003	Netiekiama	-	-	No	-	-
100097	86205	1086205	lizdinė plokštelė	N28 (alu/PVC/PVDC)		Receptinis	EU/1/18/1309/004	Netiekiama	-	-	No	-	-
100098	86206	1086206	lizdinė plokštelė	N84 (alu/PVC/PVDC)		Receptinis	EU/1/18/1309/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-07-02	Išregistruotas
2018-08-27	Registruotas