Dupixent

Medicinal product

(Invented) name

Dupixent

Active substance (s)

Dupilumabas

Strength

300 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

Registruotas

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 syringe	2 ml
Dupilumabas	300 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
98070	84168	1084168	užpildytas švirkštas	N1		Receptinis	EU/1/17/1229/005	Netiekiama	-	-	No	-	-
98071	84169	1084169	užpildytas švirkštas	N2		Receptinis	EU/1/17/1229/006	Netiekiama	-	-	No	-	-
98073	84171	1084171	užpildytas švirkštas	N6 (3x2)		Receptinis	EU/1/17/1229/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-26	Registruotas