Maci
Expired
This medicine's authorisation has expired
matrix-applied characterised autologous cultured chondrocytes
MedicineHumanExpired
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for MACI (matrix applied characterised autologous cultured chondrocytes) expired on 1 July 2018 following the decision of the marketing authorisation holder, Vericel Denmark ApS, not to pursue the renewal of the marketing authorisation.
MACI was granted marketing authorisation in the European Union (EU) on 27 June 2013 as an implant used to repair cartilage defects in the knee joint. The marketing authorisation for MACI had been suspended since 19 November 2014 due to the absence of an authorised manufacturing site for the finished product, active substance and batch release. The suspension had not been lifted prior to the expiry of the marketing authorisation.
The European Public Assessment Report (EPAR) for MACI is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Maci : EPAR - Summary for the public
Reference Number: EMA/282918/2013
English (EN) (688.83 KB - PDF)
First published: Last updated:
български (BG) (1.21 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
español (ES) (693.05 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
čeština (CS) (738.22 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
dansk (DA) (684.96 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Deutsch (DE) (690.55 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
eesti keel (ET) (731.14 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
ελληνικά (EL) (777.6 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
français (FR) (687.93 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
hrvatski (HR) (716.96 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
italiano (IT) (686.93 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
latviešu valoda (LV) (750.1 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
lietuvių kalba (LT) (761.85 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
magyar (HU) (732.61 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Malti (MT) (744.46 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Nederlands (NL) (686.55 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
polski (PL) (734.36 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
português (PT) (687.62 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
română (RO) (719.63 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
slovenčina (SK) (741.32 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
slovenščina (SL) (725.6 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Suomi (FI) (683.67 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
svenska (SV) (685.89 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Product information
Maci : EPAR - Product Information
English (EN) (1.61 MB - PDF)
First published: Last updated:
български (BG) (1.56 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
español (ES) (1.16 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
čeština (CS) (1.3 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
dansk (DA) (1.18 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Deutsch (DE) (1.19 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
eesti keel (ET) (1.23 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
ελληνικά (EL) (1.51 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
français (FR) (1.22 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
hrvatski (HR) (1.26 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
íslenska (IS) (1.09 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
italiano (IT) (1.18 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
latviešu valoda (LV) (1.37 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
lietuvių kalba (LT) (1.16 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
magyar (HU) (1.32 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Malti (MT) (1.52 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Nederlands (NL) (1.19 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
norsk (NO) (1.18 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
polski (PL) (1.31 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
português (PT) (1.04 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
română (RO) (1.19 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
slovenčina (SK) (1.38 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
slovenščina (SL) (1.27 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Suomi (FI) (1.18 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
svenska (SV) (1.09 MB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Latest procedure affecting product information:
IAIN/0009
01/07/2018
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)
First published: Last updated:
български (BG) (631.91 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
español (ES) (585.31 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
čeština (CS) (621.71 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
dansk (DA) (589.06 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Deutsch (DE) (584.48 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
eesti keel (ET) (585.33 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
ελληνικά (EL) (614.22 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
français (FR) (587.41 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
hrvatski (HR) (592.4 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
íslenska (IS) (584.71 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
italiano (IT) (585.26 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
latviešu valoda (LV) (609.45 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
lietuvių kalba (LT) (599.98 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
magyar (HU) (601.75 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Malti (MT) (608.92 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Nederlands (NL) (585.16 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
norsk (NO) (585.08 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
polski (PL) (617.16 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
português (PT) (585.38 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
română (RO) (597.94 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
slovenčina (SK) (604.84 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
slovenščina (SL) (596.47 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Suomi (FI) (589.06 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
svenska (SV) (585.04 KB - PDF)
First published: 12/07/2013Last updated: 05/07/2018
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II
English (EN) (1.15 MB - PDF)
First published: Last updated:
български (BG) (641.24 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
español (ES) (590.83 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
čeština (CS) (627.29 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
dansk (DA) (590.87 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
Deutsch (DE) (590.85 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
eesti keel (ET) (590.7 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
ελληνικά (EL) (643.03 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
français (FR) (590.93 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
hrvatski (HR) (605.09 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
italiano (IT) (591.14 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
latviešu valoda (LV) (629.43 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
lietuvių kalba (LT) (743.45 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
magyar (HU) (614.21 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
Malti (MT) (628.72 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
Nederlands (NL) (590.95 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
polski (PL) (626.71 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
português (PT) (590.93 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
română (RO) (612.28 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
slovenčina (SK) (618.53 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
slovenščina (SL) (625.13 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
Suomi (FI) (590.8 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
svenska (SV) (591.31 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
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 systemTherapeutic 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
- Expiry of marketing authorisation
- 01/07/2018
- Revision
- 4
Assessment history
Maci : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (856.98 KB - PDF)
First published: Last updated:
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I
English (EN) (1.61 MB - PDF)
First published: Last updated:
български (BG) (1.54 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
español (ES) (1.04 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
čeština (CS) (1.53 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
dansk (DA) (1.49 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
Deutsch (DE) (1.5 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
eesti keel (ET) (1.04 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
ελληνικά (EL) (1.1 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
français (FR) (1.04 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
hrvatski (HR) (1.07 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
italiano (IT) (938.56 KB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
latviešu valoda (LV) (1.08 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
lietuvių kalba (LT) (1.2 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
magyar (HU) (1.07 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
Malti (MT) (1.09 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
Nederlands (NL) (1.04 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
polski (PL) (1.08 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
português (PT) (1.04 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
română (RO) (1.08 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
slovenčina (SK) (1.07 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
slovenščina (SL) (1.08 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
Suomi (FI) (1.04 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
svenska (SV) (1.04 MB - PDF)
First published: 17/12/2014Last updated: 05/07/2018
Maci : EPAR - Public assessment report : Article-20 procedure
AdoptedReference Number: EMA/671958/2014
English (EN) (1.33 MB - PDF)
First published: Last updated:
Maci : EPAR - Public assessment report
AdoptedReference Number: EMA/25287/2013
English (EN) (4.71 MB - PDF)
First published: Last updated:
CHMP summary of positive opinion for Maci
AdoptedReference Number: EMA/54023/2013
English (EN) (810.17 KB - PDF)
First published: Last updated:
News on Maci
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