Rosuchen

Medicinal product

(Invented) name

Rosuchen

Active substance (s)

Rozuvastatinas

Strength

5 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

Antibiotice S.A, Rumunija

Date of authorisation

2016-04-06

Date of renewal

Documents

3902_1-12 Rosuchen_DP.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

RO/H/0140/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Rozuvastatinas	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
61773	76129	1076129	lizdinė plokštelė	N30		Receptinis	LT/1/16/3902/001	Netiekiama	-	-	No	-	-
65457	79961	1079961	lizdinė plokštelė	N60		Receptinis	LT/1/16/3902/002	Netiekiama	-	-	No	-	-
65458	79962	1079962	lizdinė plokštelė	N90		Receptinis	LT/1/16/3902/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-22	Išregistruotas
2016-04-06	Registruotas