Cosentyx

Medicinal product

(Invented) name

Cosentyx

Active substance (s)

Sekukinumabas

Strength

150 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)

L04AC10, Secukinumab

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2015-01-15

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	1 ml
Sekukinumabas	150 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
61142	75456	1075456	užpildytas švirkštiklis	N1 (SensoReady)		Receptinis	EU/1/14/980/004	Tiekiama	-	-	No	-	-
61143	75457	1075457	užpildytas švirkštiklis	N2 (SensoReady)		Receptinis	EU/1/14/980/005	Netiekiama	-	-	No	-	-
62260	76651	1076651	užpildytas švirkštiklis	N6 (3x2) (SensoReady, sudėtinė)		Receptinis	EU/1/14/980/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-01-15	Registruotas