MACI

Medicinal product

(Invented) name

MACI

Active substance (s)

Ant matricos perkelti charakterizuoti autologiniai kultivuoti chondrocitai

Strength

500000–1000000 ląstelių/cm²

Pharmaceutical form

implantuojamoji matrica

Route (s) of administration

implantacija

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

M09AX02, Chondrocytes, autologous

Marketing authorisation holder

Vericel Denmark ApS, Danija

Date of authorisation

2013-06-27

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Implantation matrix	1 cm²
Ant matricos perkelti charakterizuoti autologiniai kultivuoti chondrocitai	500000–1000000 ląstelių/cm²

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
56685	70788	1070788	lėkštelė	N1-2		Receptinis	EU/1/13/847/001	Netiekiama	-	-	No	-	-
56686	70789	1070789	lėkštelė	N1-2		Receptinis	EU/1/13/847/001	Netiekiama	-	-	No	-	-

Stadijos