Roswera

Medicinal product

(Invented) name

Roswera

Active substance (s)

Rozuvastatinas

Strength

15 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)

C10AA07, Rosuvastatin

Marketing authorisation holder

UAB Lex ano, Lietuva

Date of authorisation

2021-02-01

Date of renewal

Documents

1478-001-003_Roswera_15 mg_2021-02-01.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Rozuvastatinas	15 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
105689	91789	1091789	lizdinė plokštelė	N28		Receptinis	LT/L/21/1478/001	Netiekiama	-	-	No	-	-	Download
105690	91790	1091790	lizdinė plokštelė	N56		Receptinis	LT/L/21/1478/002	Netiekiama	-	-	No	-	-
105691	91791	1091791	lizdinė plokštelė	N90		Receptinis	LT/L/21/1478/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-01	Registruotas