Cisplatin Accord

Medicinal product

(Invented) name

Cisplatin Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2010-10-12

Date of renewal

2016-04-04

Documents

2176 Pakuotės lapelis 2024 11 15.docx

2176 Cisplatin Accord II PL 2024 11 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/0749/001

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
32627	35011	1035011	flakonas	10 ml N1		Receptinis	LT/1/10/2176/001	Netiekiama	-	-	No	-	-
43046	56815	1056815	flakonas	25 ml N1		Receptinis	LT/1/10/2176/002	Netiekiama	-	-	No	-	-
43047	56816	1056816	flakonas	50 ml N1		Receptinis	LT/1/10/2176/003	Tiekiama	-	-	No	-	-
47119	60932	1060932	flakonas	100 ml N1		Receptinis	LT/1/10/2176/004	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-04-04	Perregistruotas
2010-10-12	Registruotas