Apealea

Medicinal product

(Invented) name

Apealea

Active substance (s)

Paklitakselis

Strength

60 mg

Pharmaceutical form

milteliai infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01CD01, Paclitaxel

Marketing authorisation holder

Inceptua AB, Švedija

Date of authorisation

2018-11-20

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder for solution for infusion	1 vnt.
Paklitakselis	60 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
100513	86622	1086622	flakonas	N1		Receptinis	EU/1/18/1292/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-09	Išregistruotas
2018-11-20	Registruotas