Doksorubicinas Mylan [Doksorubicinas Agila]

Medicinal product

(Invented) name

Doksorubicinas Mylan [Doksorubicinas Agila]

Active substance (s)

Doksorubicinas

Strength

2 mg/ml

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

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_5_6 Doksorubicinas Mylan milt RPP 151203.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename paruošto tirpalo mililitre 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
43592	57365	1057365	flakonas	10 mg N1		Receptinis	LT/1/15/3737/005	Netiekiama	-	-	No	-	-
43593	57366	1057366	flakonas	50 mg N1		Receptinis	LT/1/15/3737/006	Netiekiama	-	-	No	-	-

Stadijos

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