Roxiper

Medicinal product

(Invented) name

Roxiper

Active substance (s)

Rozuvastatinas/tert-butilamino perindoprilis/Indapamidas

Strength

10 mg/8 mg/2,5 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)

C10BX13, Rosuvastatin, perindopril and indapamide

Marketing authorisation holder

UAB Limedika, Lietuva

Date of authorisation

2020-02-11

Date of renewal

Documents

1197_Roxiper 10mg+8mg+2.5mg_pl_deng_tab_PZPL_2020-02-11.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

tabletėje yra	1 vnt.
Rozuvastatinas	10 mg
tert-butilamino perindoprilis	8 mg
Indapamidas	2,5 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
103297	89399	1089399	lizdinė plokštelė	N30		Receptinis	LT/L/20/1197/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2020-02-11	Registruotas