Maci

RSS

matrix-applied characterised autologous cultured chondrocytes

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Maci has expired following the marketing-authorisation holder’s decision not to pursue the renewal of the marketing authorisation.

This EPAR was last updated on 05/07/2018

Authorisation details

Product details
Name
Maci
Agency product number
EMEA/H/C/002522
Active substance
autologous cultured chondrocytes
International non-proprietary name (INN) or common name
matrix-applied characterised autologous cultured chondrocytes
Therapeutic area (MeSH)
Fractures, Cartilage
Anatomical therapeutic chemical (ATC) code
M09AX02
Publication details
Marketing-authorisation holder
Vericel Denmark ApS
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
27/06/2013
Contact address
Amaliegade 10,
DK-1256 Copenhagen K
Denmark

Product information

01/07/2018 Maci - EMEA/H/C/002522 - IAIN/0009

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Other medicines for disorders of the musculoskeletal system

Therapeutic indication

Repair of symptomatic cartilage defects of the knee.

Assessment history

Changes since initial authorisation of medicine

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