Praxbind

Medicinal product

(Invented) name

Praxbind

Active substance (s)

Idarucizumabas

Strength

2,5 g/50 ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V03AB37, Idarucizumab

Marketing authorisation holder

Boehringer Ingelheim International GmbH, Vokietija

Date of authorisation

2015-11-20

Date of renewal

Documents

Search in EMA Europe

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/infusion	50 ml
Idarucizumabas	2,5 g

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
64613	79097	1079097	flakonas	50 ml N2		Receptinis	EU/1/15/1056/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-20	Registruotas