Tezulix

Medicinal product

(Invented) name

Tezulix

Active substance (s)

Ranolazinas

Strength

375 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01EB18, Ranolazine

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2023-02-22

Date of renewal

Documents

5123-5125 pakuotes lapelis_2023-02-22.docx

5123_5125 Tezulix PCS 2023 11 27.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

HR/H/0224/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Ranolazinas	375 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
110428	96538	1096538	lizdinė plokštelė	N30		Receptinis	LT/1/23/5123/001	Netiekiama	-	-	No	-	-
110429	96539	1096539	lizdinė plokštelė	N60		Receptinis	LT/1/23/5123/002	Netiekiama	-	-	No	-	-
110430	96540	1096540	lizdinė plokštelė	N100		Receptinis	LT/1/23/5123/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-02-22	Registruotas