Icatibant Teva

Medicinal product

(Invented) name

Icatibant Teva

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

Teva B.V., Nyderlandai

Date of authorisation

2021-09-22

Date of renewal

2025-10-31

Documents

4813_pakuotes lapelis_2025-10-31.docx

4813_Icatibant Teva_perr2025-10-31.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/2064/001/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
107265	93369	1093369	užpildytas švirkštas	3 ml ir adata N1		Receptinis	LT/1/21/4813/001	Netiekiama	2024-12-30	-	No	-	-
107266	93370	1093370	užpildytas švirkštas	3 ml ir adata N3		Receptinis	LT/1/21/4813/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-10-31	Perregistruotas
2021-09-22	Registruotas