ellaOne

Medicinal product

(Invented) name

ellaOne

Active substance (s)

Ulipristalio acetatas

Strength

30 mg

Pharmaceutical form

tabletė

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03AD02, Ulipristal

Marketing authorisation holder

Laboratoire HRA Pharma, Prancūzija

Date of authorisation

2009-05-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

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	30 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
35550	37883	1037883	lizdinė plokštelė	N1 (PVC/PE/PVDC/Alu)		Nereceptinis	EU/1/09/522/001	Tiekiama	-	-	No	-	-
97620	83714	1083714	lizdinė plokštelė	N1 (PVC/PVDC/alu)		Nereceptinis	EU/1/09/522/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-05-15	Registruotas