Kyntheum

Medicinal product

(Invented) name

Kyntheum

Active substance (s)

Brodalumabas

Strength

210 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)

L04AC12, Brodalumab

Marketing authorisation holder

LEO Pharma A/S, Danija

Date of authorisation

2017-07-17

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 syringe	1.5 ml
Brodalumabas	210 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
68820	83403	1083403	užpildytas švirkštas	1,5 ml N2		Receptinis	EU/1/16/1155/001	Netiekiama	-	-	No	-	-
98477	84580	1084580	užpildytas švirkštas	1,5 ml N6 (3x2) (sudėtinė)		Receptinis	EU/1/16/1155/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-07-17	Registruotas