Rosuvastatin Atb

Medicinal product

(Invented) name

Rosuvastatin Atb

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

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/0117/001/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
54885	68909	1068909	lizdinė plokštelė	N30		Receptinis	LT/1/14/3616/001	Netiekiama	-	-	No	-	-
60116	74387	1074387	lizdinė plokštelė	N60		Receptinis	LT/1/14/3616/002	Netiekiama	-	-	No	-	-
60117	74388	1074388	lizdinė plokštelė	N90		Receptinis	LT/1/14/3616/003	Netiekiama	-	-	No	-	-

Stadijos

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