ZINPLAVA

Medicinal product

(Invented) name

ZINPLAVA

Active substance (s)

Bezlotoksumabas

Strength

25 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J06BC03, Bezlotoxumab

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2017-01-18

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

Concentrate for solution for infusion	1 ml
Bezlotoksumabas	25 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
67419	81971	1081971	flakonas	40 ml N1		Receptinis	EU/1/16/1156/001	Netiekiama	-	-	No	-	-
111293	97406	1097406	flakonas	25 ml N1		Receptinis	EU/1/16/1156/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-01-18	Registruotas