Cisplatin EBEWE

Medicinal product

(Invented) name

Cisplatin EBEWE

Active substance (s)

Cisplatina

Strength

0,5 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)

L01XA01, Cisplatin

Marketing authorisation holder

Ebewe Pharma Ges.m.b.H. Nfg. KG, Austrija

Date of authorisation

1995-10-04

Date of renewal

2007-05-09

Documents

0729_1_3 Cisplatin Ebewe konc RPP 160217.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Cisplatina	0,5 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
22645	476	1000476	flakonas	flakonas (20 ml), N1		Receptinis	LT/1/95/0729/001	Netiekiama	-	-	No	-	-	Download
22646	25406	1025406	flakonas	flakonas (50 ml), N1		Receptinis	LT/1/95/0729/002	Netiekiama	-	-	No	-	-
1859	478	1000478	flakonas	flakonas (100 ml), N1		Receptinis	LT/1/95/0729/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-05-05	Išregistruotas
2007-05-09	Perregistruotas
1995-10-04	Registruotas