Ocrevus

Medicinal product

(Invented) name

Ocrevus

Active substance (s)

Okrelizumabas

Strength

300 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)

L04AG08, Ocrelizumab

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2018-01-08

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

Concentrate for solution for infusion	10 ml
Okrelizumabas	300 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
98685	84789	1084789	flakonas	10 ml N1		Receptinis	EU/1/17/1231/001	Tiekiama	-	-	No	-	-
98686	84790	1084790	flakonas	10 ml N2		Receptinis	EU/1/17/1231/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-01-08	Registruotas