Zinbryta

Medicinal product

(Invented) name

Zinbryta

Active substance (s)

Daklizumabas

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)

L04AC01, Daclizumab

Marketing authorisation holder

Biogen Idec Ltd., Jungtinė Karalystė

Date of authorisation

2016-07-01

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled pen	1 ml
Daklizumabas	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
66238	80761	1080761	užpildytas švirkštiklis	N1		Receptinis	EU/1/16/1107/003	Netiekiama	-	-	No	-	-
66239	80762	1080762	užpildytas švirkštiklis	N3 (3x1) (sudėtinė)		Receptinis	EU/1/16/1107/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-03-29	Išregistruotas
2018-03-08	Sustabdytas
2016-07-01	Registruotas