Overview

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

Maci : EPAR - Summary for the public

Reference Number: EMA/282918/2013

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slovenščina (SL) (725.6 KB - PDF)

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Suomi (FI) (683.67 KB - PDF)

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svenska (SV) (685.89 KB - PDF)

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Product information

Maci : EPAR - Product Information

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български (BG) (1.56 MB - PDF)

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ελληνικά (EL) (1.51 MB - PDF)

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italiano (IT) (1.18 MB - PDF)

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latviešu valoda (LV) (1.37 MB - PDF)

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lietuvių kalba (LT) (1.16 MB - PDF)

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svenska (SV) (1.09 MB - PDF)

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Latest procedure affecting product information: IAIN/0009

01/07/2018

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Maci : EPAR - All Authorised presentations

English (EN) (836.87 KB - PDF)

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български (BG) (631.91 KB - PDF)

First published: 12/07/2013Last updated: 05/07/2018
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español (ES) (585.31 KB - PDF)

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čeština (CS) (621.71 KB - PDF)

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dansk (DA) (589.06 KB - PDF)

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Deutsch (DE) (584.48 KB - PDF)

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eesti keel (ET) (585.33 KB - PDF)

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ελληνικά (EL) (614.22 KB - PDF)

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français (FR) (587.41 KB - PDF)

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hrvatski (HR) (592.4 KB - PDF)

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íslenska (IS) (584.71 KB - PDF)

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italiano (IT) (585.26 KB - PDF)

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latviešu valoda (LV) (609.45 KB - PDF)

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lietuvių kalba (LT) (599.98 KB - PDF)

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magyar (HU) (601.75 KB - PDF)

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Malti (MT) (608.92 KB - PDF)

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Nederlands (NL) (585.16 KB - PDF)

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norsk (NO) (585.08 KB - PDF)

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polski (PL) (617.16 KB - PDF)

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português (PT) (585.38 KB - PDF)

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română (RO) (597.94 KB - PDF)

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slovenščina (SL) (596.47 KB - PDF)

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Suomi (FI) (589.06 KB - PDF)

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svenska (SV) (585.04 KB - PDF)

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Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II

English (EN) (1.15 MB - PDF)

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български (BG) (641.24 KB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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čeština (CS) (627.29 KB - PDF)

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dansk (DA) (590.87 KB - PDF)

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Deutsch (DE) (590.85 KB - PDF)

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eesti keel (ET) (590.7 KB - PDF)

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ελληνικά (EL) (643.03 KB - PDF)

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français (FR) (590.93 KB - PDF)

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hrvatski (HR) (605.09 KB - PDF)

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italiano (IT) (591.14 KB - PDF)

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latviešu valoda (LV) (629.43 KB - PDF)

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lietuvių kalba (LT) (743.45 KB - PDF)

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português (PT) (590.93 KB - PDF)

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română (RO) (612.28 KB - PDF)

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slovenčina (SK) (618.53 KB - PDF)

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slovenščina (SL) (625.13 KB - PDF)

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Suomi (FI) (590.8 KB - PDF)

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svenska (SV) (591.31 KB - PDF)

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Product details

Name of medicine
Maci
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

Pharmacotherapeutic group

Other drugs for disorders of the musculo-skeletal system

Therapeutic indication

Repair of symptomatic cartilage defects of the knee.

Authorisation details

EMA product number
EMEA/H/C/002522

Advanced therapy

This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.

Marketing authorisation holder
Vericel Denmark ApS

Amaliegade 10,
DK-1256 Copenhagen K
Denmark

Marketing authorisation issued
27/06/2013
Revision
4

Assessment history

Maci : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (856.98 KB - PDF)

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Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I

English (EN) (1.61 MB - PDF)

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български (BG) (1.54 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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español (ES) (1.04 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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čeština (CS) (1.53 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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dansk (DA) (1.49 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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Deutsch (DE) (1.5 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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eesti keel (ET) (1.04 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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ελληνικά (EL) (1.1 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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français (FR) (1.04 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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hrvatski (HR) (1.07 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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italiano (IT) (938.56 KB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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latviešu valoda (LV) (1.08 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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lietuvių kalba (LT) (1.2 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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magyar (HU) (1.07 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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Malti (MT) (1.09 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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Nederlands (NL) (1.04 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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polski (PL) (1.08 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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português (PT) (1.04 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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română (RO) (1.08 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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slovenčina (SK) (1.07 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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slovenščina (SL) (1.08 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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Suomi (FI) (1.04 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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svenska (SV) (1.04 MB - PDF)

First published: 17/12/2014Last updated: 05/07/2018
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Maci : EPAR - Public assessment report : Article-20 procedure

AdoptedReference Number: EMA/671958/2014

English (EN) (1.33 MB - PDF)

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Maci : EPAR - Public assessment report

AdoptedReference Number: EMA/25287/2013

English (EN) (4.71 MB - PDF)

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CHMP summary of positive opinion for Maci

AdoptedReference Number: EMA/54023/2013

English (EN) (810.17 KB - PDF)

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More information on Maci

Public statement on Maci: Expiry of the marketing authorisation in the European Union

Reference Number: EMA/457300/2018

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