Ruxience

Medicinal product

(Invented) name

Ruxience

Active substance (s)

Rituksimabas

Strength

100 mg

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FA01, Rituximab

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2020-04-01

Date of renewal

Documents

Ruxience paciento budrumo lapelis.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	1 ml
Rituksimabas	100 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
103740	89842	1089842	flakonas	10 ml N1		Receptinis	EU/1/20/1431/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-01	Registruotas