Firazyr

Medicinal product

(Invented) name

Firazyr

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)

ATC code (s)

B06AC02, Icatibant

Marketing authorisation holder

Takeda Pharmaceuticals International AG Ireland Branch, Airija

Date of authorisation

2008-07-11

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

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
31220	33654	1033654	užpildytas švirkštas	3 ml ir adata N1		Receptinis	EU/1/08/461/001	Tiekiama	-	-	No	-	-
49882	63755	1063755	užpildytas švirkštas	3 ml ir adata N3 (3×1)		Receptinis	EU/1/08/461/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-07-11	Registruotas