Rosuvastatin Atb

Medicinal product

(Invented) name

Rosuvastatin Atb

Active substance (s)

Rozuvastatinas

Strength

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)

C10AA07, Rosuvastatin

Marketing authorisation holder

Antibiotice S.A, Rumunija

Date of authorisation

2014-09-04

Date of renewal

Documents

3616_1_12 Rosuvastatin Atb PCS PL 160620.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

RO/H/0117/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Rozuvastatinas	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
54886	68910	1068910	lizdinė plokštelė	N30		Receptinis	LT/1/14/3616/004	Netiekiama	-	-	No	-	-
60118	74389	1074389	lizdinė plokštelė	N60		Receptinis	LT/1/14/3616/005	Netiekiama	-	-	No	-	-
60119	74390	1074390	lizdinė plokštelė	N90		Receptinis	LT/1/14/3616/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-09	Išregistruotas
2014-09-04	Registruotas