ZALTRAP

Medicinal product

(Invented) name

ZALTRAP

Active substance (s)

Afliberceptas

Strength

25 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)

L01XX44, Aflibercept

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2013-02-01

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

Concentrate for solution for infusion	1 ml
Afliberceptas	25 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
55205	69238	1069238	flakonas	N1 (100 mg/4 ml)		Receptinis	EU/1/12/814/001	Netiekiama	2025-10-20	2026-02-02	No	-	-
55206	69239	1069239	flakonas	N3 (100 mg/4 ml)		Receptinis	EU/1/12/814/002	Netiekiama	-	-	No	-	-
55207	69240	1069240	flakonas	N1 (200 mg/8 ml)		Receptinis	EU/1/12/814/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-02-01	Registruotas