Trogarzo

Medicinal product

(Invented) name

Trogarzo

Active substance (s)

Ibalizumabas

Strength

200 mg

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)

J05AX23, ibalizumab

Marketing authorisation holder

Theratechnologies International Limited, Airija

Date of authorisation

2019-09-26

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	1 vnt.
Ibalizumabas	200 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
102459	88560	1088560	flakonas	N2		Receptinis	EU/1/19/1359/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-01-01	Išregistruotas
2019-09-26	Registruotas