Cisplatin Mylan

Medicinal product

(Invented) name

Cisplatin Mylan

Active substance (s)

Cisplatina

Strength

1 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

Mylan S.A.S., Prancūzija

Date of authorisation

2012-07-19

Date of renewal

Documents

3014_1_2 Cisplatin Mylan II PL 160530.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2083/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Cisplatina	1 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
42573	56340	1056340	flakonas	50 ml N1		Receptinis	LT/1/12/3014/001	Netiekiama	-	-	No	-	-
42574	56341	1056341	flakonas	100 ml N1		Receptinis	LT/1/12/3014/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-06-06	Išregistruotas
2012-07-19	Registruotas