Romazic

Medicinal product

(Invented) name

Romazic

Active substance (s)

Rozuvastatinas

Strength

30 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

2020-04-10

Date of renewal

2024-09-23

Documents

4540-41_Romazic_perr2024-09-23.docx

4540-41_pakuotes lapelis_2024-09-23.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

LV/H/0126/006/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Rozuvastatinas	30 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
103784	89886	1089886	lizdinė plokštelė	N30		Receptinis	LT/1/20/4541/001	Netiekiama	-	-	No	-	-	Download
103785	89887	1089887	lizdinė plokštelė	N60		Receptinis	LT/1/20/4541/002	Netiekiama	-	-	No	-	-
103786	89888	1089888	lizdinė plokštelė	N90		Receptinis	LT/1/20/4541/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-09-23	Perregistruotas
2020-04-10	Registruotas