Cablivi

Medicinal product

(Invented) name

Cablivi

Active substance (s)

Kaplacizumabas

Strength

10 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B01AX07, Caplacizumab

Marketing authorisation holder

Ablynx NV, Belgija

Date of authorisation

2018-08-31

Date of renewal

Documents

Cablivi paciento ispejamoji 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

Powder and solvent for solution for injection	1 vnt.
Kaplacizumabas	10 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
100091	86199	1086199	flakonas	milteliai, tirpiklio užpildytas švirkštas, flakono adapteris, adata ir 2 alkoholiu suvilgyti tamponai N1		Receptinis	EU/1/18/1305/001	Netiekiama	-	-	No	-	-
100645	86755	1086755	flakonas	milteliai, tirpiklio užpildytas švirkštas, flakono adapteris, adata ir 2 alkoholiu suvilgyti tamponai N7		Receptinis	EU/1/18/1305/002	Netiekiama	-	-	No	-	-
101254	87361	1087361	flakonas	milteliai, tirpiklio užpildyti švirkštai, flakono adapteriai, adatos ir tamponai N7 (7x1)		Receptinis	EU/1/18/1305/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-08-31	Registruotas