Dupixent

Medicinal product

(Invented) name

Dupixent

Active substance (s)

Dupilumabas

Strength

100 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D11AH05, Dupilumab

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2017-09-26

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

Solution for injection in pre-filled pen	0.67 ml
Dupilumabas	100 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
108405	94509	1094509	užpildytas švirkštas	N2 (su adatos apsauga)		Receptinis	EU/1/17/1229/021	Netiekiama	-	-	No	-	-
108406	94510	1094510	užpildytas švirkštas	N6 (3×2) (su adatos apsauga)		Receptinis	EU/1/17/1229/022	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-28	Išregistruotas
2017-09-26	Registruotas