Romazic

Medicinal product

(Invented) name

Romazic

Active substance (s)

Rozuvastatinas

Strength

20 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

Pharmaceutical Works POLPHARMA S.A., Lenkija

Date of authorisation

2011-11-09

Date of renewal

2016-09-09

Documents

2690 Romazic 5,10,20,40 PCS 2023 11 15.docx

2690 Pakuotės lapelis 2023 05 24.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0126/003

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Rozuvastatinas	20 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
41024	54768	1054768	lizdinė plokštelė	N30		Receptinis	LT/1/11/2690/003	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2016-09-09	Perregistruotas
2011-11-09	Registruotas