Doksorubicinas Mylan [Doksorubicinas Agila]

Medicinal product

(Invented) name

Doksorubicinas Mylan [Doksorubicinas Agila]

Active substance (s)

Doksorubicinas

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

Mylan S.A.S., Prancūzija

Date of authorisation

2015-06-16

Date of renewal

Documents

3737_1_4 Doksorubicinas Mylan konc RPP 151203.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Doksorubicinas	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
43588	57361	1057361	flakonas	5 ml N1 (10 mg/5 ml)		Receptinis	LT/1/15/3737/001	Netiekiama	-	-	No	-	-
43589	57362	1057362	flakonas	10 ml N1 (20 mg /10 ml)		Receptinis	LT/1/15/3737/002	Netiekiama	-	-	No	-	-
43590	57363	1057363	flakonas	25 ml N1 (50 mg/25 ml)		Receptinis	LT/1/15/3737/003	Netiekiama	-	-	No	-	-
43591	57364	1057364	flakonas	100 ml N1 (200 mg/100 ml)		Receptinis	LT/1/15/3737/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-07-04	Išregistruotas
2015-06-16	Registruotas