Rosuchen

Medicinal product

(Invented) name

Rosuchen

Active substance (s)

Rozuvastatinas

Strength

40 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/0140/004/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Rozuvastatinas	40 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
61776	76132	1076132	lizdinė plokštelė	N30		Receptinis	LT/1/16/3902/010	Netiekiama	-	-	No	-	-
65463	79967	1079967	lizdinė plokštelė	N60		Receptinis	LT/1/16/3902/011	Netiekiama	-	-	No	-	-
65464	79968	1079968	lizdinė plokštelė	N90		Receptinis	LT/1/16/3902/012	Netiekiama	-	-	No	-	-

Stadijos

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