TEPEZZA

Medicinal product

(Invented) name

TEPEZZA

Active substance (s)

Teprotumumabas

Strength

500 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AG13, teprotumumab

Marketing authorisation holder

Amgen Europe B.V., Nyderlandai

Date of authorisation

2025-06-19

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

Flakone yra	1 vnt.
Teprotumumabas	500 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
117890	103995	1103995	flakonas	N1		Receptinis	EU/1/25/1941/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-19	Registruotas