Apexelsin

Medicinal product

(Invented) name

Apexelsin

Active substance (s)

Paklitakselis

Strength

5 mg/ml

Pharmaceutical form

milteliai dispersinei infuzijai

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

WhiteOak Pharmaceutical B.V., Nyderlandai

Date of authorisation

2024-07-24

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

1 ml paruoštos dispersijos mililitre yra:	1 ml
Paklitakselis	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
114661	100768	1100768	flakonas	N1		Receptinis	EU/1/24/1835/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-24	Registruotas