Hemlibra

Medicinal product

(Invented) name

Hemlibra

Active substance (s)

Emicizumabas

Strength

150 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B02BX06, Emicizumab

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2018-02-23

Date of renewal

Documents

Hemlibra mokomoji medziaga laboratorines medicinos specialistams.pdf

Hemlibra mokomoji medziaga pacientams.pdf

Hemlibra mokomoji medziaga sveikatos prieziuros specialistams.pdf

Hemlibra paciento kortele.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	1 ml
Emicizumabas	150 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
99117	85223	1085223	flakonas	0,4 ml N1		Receptinis	EU/1/18/1271/002	Tiekiama	-	-	No	-	-
99118	85224	1085224	flakonas	0,7 ml N1		Receptinis	EU/1/18/1271/003	Tiekiama	-	-	No	-	-
99119	85225	1085225	flakonas	1 ml N1		Receptinis	EU/1/18/1271/004	Tiekiama	-	-	No	-	-
110979	97090	1097090	flakonas	2 ml N1		Receptinis	EU/1/18/1271/005	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-02-23	Registruotas