Roselia

Medicinal product

(Invented) name

Roselia

Active substance (s)

Rozuvastatinas/Ezetimibas

Strength

20 mg/10 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)

C10BA06, Rosuvastatin and ezetimibe

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2023-01-31

Date of renewal

Documents

5111_5112 Roselia II PL 2024 02 16.docx

5111_5112 Pakuotės lapelis 2024 02 16.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

HU/H/0753/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Rozuvastatinas	20 mg
Ezetimibas	10 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
110283	96394	1096394	lizdinė plokštelė	N30		Receptinis	LT/1/23/5112/001	Netiekiama	-	-	No	-	-
110284	96395	1096395	lizdinė plokštelė	N90		Receptinis	LT/1/23/5112/002	Netiekiama	-	-	No	-	-
110285	96396	1096396	dalomoji lizdinė plokštelė	N30×1		Receptinis	LT/1/23/5112/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-01-31	Registruotas