Carboplatin Accord

Medicinal product

(Invented) name

Carboplatin Accord

Active substance (s)

Karboplatina

Strength

10 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)

L01XA02, Carboplatin

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2009-12-23

Date of renewal

2021-08-16

Documents

1811 Pakuotės lapelis 2025 02 12.docx

1811 Carboplatin Accord II PL 2025 02 12.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1908/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Karboplatina	10 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
22378	5461	1005461	buteliukas	5 ml N1		Receptinis	LT/1/09/1811/001	Netiekiama	-	-	No	-	-
23293	5465	1005465	buteliukas	15 ml N1		Receptinis	LT/1/09/1811/002	Tiekiama	-	-	No	-	-
38502	52184	1052184	buteliukas	45 ml N1		Receptinis	LT/1/09/1811/003	Tiekiama	-	-	No	-	-
48124	61949	1061949	buteliukas	60 ml N1		Receptinis	LT/1/09/1811/004	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-08-16	Perregistruotas
2009-12-23	Registruotas