Kesimpta

Medicinal product

(Invented) name

Kesimpta

Active substance (s)

Ofatumumabas

Strength

20 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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

Solution for injection in pre-filled pen	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
106236	92337	1092337	užpildytas švirkštiklis	0,4 ml N1 (Sensoready Pen)		Receptinis	EU/1/21/1532/003	Tiekiama	-	-	No	-	-
106237	92338	1092338	užpildytas švirkštiklis	0,4 ml N3 (3x1) (Sensoready Pen)		Receptinis	EU/1/21/1532/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-26	Registruotas