Tofidence

Medicinal product

(Invented) name

Tofidence

Active substance (s)

Tocilizumabas

Strength

20 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AC07, Tocilizumab

Marketing authorisation holder

Biogen Netherlands B.V., Nyderlandai

Date of authorisation

2024-06-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Kiekviename ml koncentrato yra	1 ml
Tocilizumabas	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
114004	100120	1100120	flakonas	4 ml N1		Receptinis	EU/1/24/1825/001	Netiekiama	-	-	No	-	-
114005	100121	1100121	flakonas	4 ml N4		Receptinis	EU/1/24/1825/002	Netiekiama	-	-	No	-	-
114006	100122	1100122	flakonas	10 ml N1		Receptinis	EU/1/24/1825/003	Netiekiama	-	-	No	-	-
114007	100123	1100123	flakonas	10 ml N4		Receptinis	EU/1/24/1825/004	Netiekiama	-	-	No	-	-
114008	100124	1100124	flakonas	20 ml N1		Receptinis	EU/1/24/1825/005	Netiekiama	-	-	No	-	-
114009	100125	1100125	flakonas	20 ml N4		Receptinis	EU/1/24/1825/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-06-20	Registruotas