Icatibant Fresenius

Medicinal product

(Invented) name

Icatibant Fresenius

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

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2022-01-28

Date of renewal

Documents

4887 Icatibant Fresenius PCS PL 2024 04 15.docx

4887 Pakuotės lapelis 2024 04 15.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3184/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Užpildytame švirkšte (3 ml tirpalo) yra:	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
107974	94079	1094079	užpildytas švirkštas	3 ml ir adata N1		Receptinis	LT/1/22/4887/001	Tiekiama	-	-	No	-	-	Download
107975	94080	1094080	užpildytas švirkštas	3 ml ir adata N3		Receptinis	LT/1/22/4887/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-01-28	Registruotas