Ulipristal acetate Sandoz

Medicinal product

(Invented) name

Ulipristal acetate Sandoz

Active substance (s)

Ulipristalio acetatas

Strength

30 mg

Pharmaceutical form

plėvele dengta 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

Sandoz d.d., Slovėnija

Date of authorisation

2019-10-01

Date of renewal

Documents

4446 Pakuotės lapelis 2022 06 30.docx

4446 Ulipristal acetate Sandoz PCS PL 2022 06 30.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0862/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	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
102458	88559	1088559	lizdinė plokštelė	N1		Nereceptinis	LT/1/19/4446/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-05-31	Išregistruotas
2019-10-01	Registruotas