MYLOTARG

Medicinal product

(Invented) name

MYLOTARG

Active substance (s)

Gemtuzumabas ozogamicinas

Strength

5 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FX02, Gemtuzumab ozogamicin

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2018-04-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder for concentrate for solution for infusion	1 vnt.
Gemtuzumabas ozogamicinas	5 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
99437	85544	1085544	flakonas	N1		Receptinis	EU/1/18/1277/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-04-19	Registruotas