Riboirino

Medicinal product

(Invented) name

Riboirino

Active substance (s)

Irinotekano hidrochloridas trihidratas

Strength

20 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XX09, Miltefosine

Marketing authorisation holder

UAB Edupharma, Lietuva

Date of authorisation

2019-04-17

Date of renewal

Documents

0873_Riboirino_PZPL_2019-04-17.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Irinotekano hidrochloridas trihidratas	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
101467	87570	1087570	flakonas	2 ml N1	ASPĮ	Receptinis	LT/L/19/0873/001	Netiekiama	-	-	No	-	-	Download
101468	87571	1087571	flakonas	25 ml N1	ASPĮ	Receptinis	LT/L/19/0873/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-02-21	Išregistruotas
2019-04-17	Registruotas