Ocrevus

Medicinal product

(Invented) name

Ocrevus

Active substance (s)

Okrelizumabas

Strength

920 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

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

Flakone yra:	23 ml
Okrelizumabas	920 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
114003	100119	1100119	flakonas	23 ml N1		Receptinis	EU/1/17/1231/003	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-01-08	Registruotas