Carboplatin Actavis

Medicinal product

(Invented) name

Carboplatin Actavis

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2010-04-16

Date of renewal

2018-09-10

Documents

1950_1-5 Carboplatin Actavis_perr2018-09-10.docx

1950_1-5 Pakuotes lapelis_2018-09-10.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2808/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato infuziniam tirpalui 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
29086	31594	1031594	flakonas	5 ml N1		Receptinis	LT/1/10/1950/001	Netiekiama	-	-	No	-	-
29087	31595	1031595	flakonas	15 ml N1		Receptinis	LT/1/10/1950/002	Netiekiama	-	-	No	-	-
29088	31596	1031596	flakonas	45 ml N1		Receptinis	LT/1/10/1950/003	Netiekiama	-	-	No	-	-
29089	31597	1031597	flakonas	60 ml N1		Receptinis	LT/1/10/1950/004	Netiekiama	-	-	No	-	-
42120	55884	1055884	flakonas	5 ml, N5		Receptinis	LT/1/10/1950/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-09-11	Išregistruotas
2018-09-10	Perregistruotas
2010-04-16	Registruotas