TAKHZYRO

Medicinal product

(Invented) name

TAKHZYRO

Active substance (s)

Lanadelumabas

Strength

300 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)

B06AC05, Lanadelumab

Marketing authorisation holder

Takeda Pharmaceuticals International AG Ireland Branch, Airija

Date of authorisation

2018-11-22

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	2 ml
Lanadelumabas	300 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
105675	91775	1091775	užpildytas švirkštas	2 ml N1	Receptinis	EU/1/18/1340/004	Tiekiama	-	-	No	-	-
105676	91776	1091776	užpildytas švirkštas	2 ml N2	Receptinis	EU/1/18/1340/005	Netiekiama	-	-	No	-	-
105677	91777	1091777	užpildytas švirkštas	2 ml N6 (3x2)	Receptinis	EU/1/18/1340/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-11-22	Registruotas