Kesimpta

Medicinal product

(Invented) name

Kesimpta

Active substance (s)

Ofatumumabas

Strength

20 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AG12, ofatumumab

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2021-03-26

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

Užpildytame švirkšte (0,4 ml) yra:	0.4 ml
Ofatumumabas	20 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
106234	92335	1092335	užpildytas švirkštas	0,4 ml N1		Receptinis	EU/1/21/1532/001	Netiekiama	-	-	No	-	-
106235	92336	1092336	užpildytas švirkštas	0,4 ml N3 (3x1)		Receptinis	EU/1/21/1532/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-26	Registruotas