Teizeild

Medicinal product

(Invented) name

Teizeild

Active substance (s)

Teplizumabas

Strength

1 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)

A10XX01, teplizumab

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2026-01-08

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

1 ml infuzinio tirpalo yra:	1 ml
Teplizumabas	1 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
119583	105689	1105689	flakonas	2 ml N1		Receptinis	EU/1/25/1998/001	Netiekiama	-	-	No	-	-
119584	105690	1105690	flakonas	2 ml N10		Receptinis	EU/1/25/1998/002	Netiekiama	-	-	No	-	-
119585	105691	1105691	flakonas	2 ml N14		Receptinis	EU/1/25/1998/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-01-08	Registruotas