Idanuz [Idisan]

Medicinal product

(Invented) name

Idanuz [Idisan]

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

UAB Norameda, Lietuva

Date of authorisation

2024-08-09

Date of renewal

Documents

5537 Idanuz RPP 2024 12 12.docx

5537 Pakuotės lapelis 2024 12 12.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3201/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Užpildytame švirkšte (3 ml) 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
114640	100745	1100745	užpildytas švirkštas	3 ml tirpalo ir 25 G adata N1		Receptinis	LT/1/24/5537/001	Netiekiama	-	-	No	-	-
114641	100746	1100746	užpildytas švirkštas	3 ml tirpalo ir 25 G adata N3		Receptinis	LT/1/24/5537/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-09	Registruotas