Icatibant Accord

Medicinal product

(Invented) name

Icatibant Accord

Active substance (s)

Ikatibantas

Strength

30 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)

B06AC02, Icatibant

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2021-07-16

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled syringe	3 ml
Ikatibantas	30 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
106944	93047	1093047	užpildytas švirkštas	N1 (ir adata)		Receptinis	EU/1/21/1567/001	Netiekiama	-	-	No	-	-
106945	93048	1093048	užpildytas švirkštas	N3 (ir adata)		Receptinis	EU/1/21/1567/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-07-16	Registruotas