Abraxane

Medicinal product

(Invented) name

Abraxane

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

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2008-01-11

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 dispersion for infusion	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
29576	32063	1032063	flakonas	100 mg N1		Receptinis	EU/1/07/428/001	Tiekiama	-	-	No	-	-
58601	72784	1072784	flakonas	250 mg N1		Receptinis	EU/1/07/428/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-01-11	Registruotas