Doxorubicin Accord

Medicinal product

(Invented) name

Doxorubicin Accord

Active substance (s)

Doksorubicino hidrochloridas

Strength

2 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną, vartoti į šlapimo pūslę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01DB01, Doxorubicin

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2010-08-13

Date of renewal

2017-11-23

Documents

2139 Doxorubicin Accord II PL 2025 10 28.docx

2139 Pakuotės lapelis 2025 10 28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/4562/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml koncentrato yra	1 ml
Doksorubicino hidrochloridas	2 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
31156	33601	1033601	flakonas	5 ml N1		Receptinis	LT/1/10/2139/001	Netiekiama	-	-	No	-	-
31157	33602	1033602	flakonas	25 ml N1		Receptinis	LT/1/10/2139/002	Netiekiama	2026-01-01	2026-06-30	Yes	2026-01-01	2026-06-30
31158	33603	1033603	flakonas	100 ml N1		Receptinis	LT/1/10/2139/003	Netiekiama	-	-	No	-	-
55140	69173	1069173	flakonas	10 ml N1		Receptinis	LT/1/10/2139/004	Netiekiama	-	-	No	-	-
59007	73228	1073228	flakonas	50 ml N1		Receptinis	LT/1/10/2139/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-11-23	Perregistruotas
2010-08-13	Registruotas