- 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Public Assessment Report (EPAR) for MACI is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.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
English (EN) (688.83 KB - PDF)
български (BG) (1.21 MB - PDF)
español (ES) (693.05 KB - PDF)
čeština (CS) (738.22 KB - PDF)
dansk (DA) (684.96 KB - PDF)
Deutsch (DE) (690.55 KB - PDF)
eesti keel (ET) (731.14 KB - PDF)
ελληνικά (EL) (777.6 KB - PDF)
français (FR) (687.93 KB - PDF)
hrvatski (HR) (716.96 KB - PDF)
italiano (IT) (686.93 KB - PDF)
latviešu valoda (LV) (750.1 KB - PDF)
lietuvių kalba (LT) (761.85 KB - PDF)
magyar (HU) (732.61 KB - PDF)
Malti (MT) (744.46 KB - PDF)
Nederlands (NL) (686.55 KB - PDF)
polski (PL) (734.36 KB - PDF)
português (PT) (687.62 KB - PDF)
română (RO) (719.63 KB - PDF)
slovenčina (SK) (741.32 KB - PDF)
slovenščina (SL) (725.6 KB - PDF)
Suomi (FI) (683.67 KB - PDF)
svenska (SV) (685.89 KB - PDF)
Product information
Maci : EPAR - Product Information
English (EN) (1.61 MB - PDF)
български (BG) (1.56 MB - PDF)
español (ES) (1.16 MB - PDF)
čeština (CS) (1.3 MB - PDF)
dansk (DA) (1.18 MB - PDF)
Deutsch (DE) (1.19 MB - PDF)
eesti keel (ET) (1.23 MB - PDF)
ελληνικά (EL) (1.51 MB - PDF)
français (FR) (1.22 MB - PDF)
hrvatski (HR) (1.26 MB - PDF)
íslenska (IS) (1.09 MB - PDF)
italiano (IT) (1.18 MB - PDF)
latviešu valoda (LV) (1.37 MB - PDF)
lietuvių kalba (LT) (1.16 MB - PDF)
magyar (HU) (1.32 MB - PDF)
Malti (MT) (1.52 MB - PDF)
Nederlands (NL) (1.19 MB - PDF)
norsk (NO) (1.18 MB - PDF)
polski (PL) (1.31 MB - PDF)
português (PT) (1.04 MB - PDF)
română (RO) (1.19 MB - PDF)
slovenčina (SK) (1.38 MB - PDF)
slovenščina (SL) (1.27 MB - PDF)
Suomi (FI) (1.18 MB - PDF)
svenska (SV) (1.09 MB - PDF)
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)
български (BG) (631.91 KB - PDF)
español (ES) (585.31 KB - PDF)
čeština (CS) (621.71 KB - PDF)
dansk (DA) (589.06 KB - PDF)
Deutsch (DE) (584.48 KB - PDF)
eesti keel (ET) (585.33 KB - PDF)
ελληνικά (EL) (614.22 KB - PDF)
français (FR) (587.41 KB - PDF)
hrvatski (HR) (592.4 KB - PDF)
íslenska (IS) (584.71 KB - PDF)
italiano (IT) (585.26 KB - PDF)
latviešu valoda (LV) (609.45 KB - PDF)
lietuvių kalba (LT) (599.98 KB - PDF)
magyar (HU) (601.75 KB - PDF)
Malti (MT) (608.92 KB - PDF)
Nederlands (NL) (585.16 KB - PDF)
norsk (NO) (585.08 KB - PDF)
polski (PL) (617.16 KB - PDF)
português (PT) (585.38 KB - PDF)
română (RO) (597.94 KB - PDF)
slovenčina (SK) (604.84 KB - PDF)
slovenščina (SL) (596.47 KB - PDF)
Suomi (FI) (589.06 KB - PDF)
svenska (SV) (585.04 KB - PDF)
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II
English (EN) (1.15 MB - PDF)
български (BG) (641.24 KB - PDF)
español (ES) (590.83 KB - PDF)
čeština (CS) (627.29 KB - PDF)
dansk (DA) (590.87 KB - PDF)
Deutsch (DE) (590.85 KB - PDF)
eesti keel (ET) (590.7 KB - PDF)
ελληνικά (EL) (643.03 KB - PDF)
français (FR) (590.93 KB - PDF)
hrvatski (HR) (605.09 KB - PDF)
italiano (IT) (591.14 KB - PDF)
latviešu valoda (LV) (629.43 KB - PDF)
lietuvių kalba (LT) (743.45 KB - PDF)
magyar (HU) (614.21 KB - PDF)
Malti (MT) (628.72 KB - PDF)
Nederlands (NL) (590.95 KB - PDF)
polski (PL) (626.71 KB - PDF)
português (PT) (590.93 KB - PDF)
română (RO) (612.28 KB - PDF)
slovenčina (SK) (618.53 KB - PDF)
slovenščina (SL) (625.13 KB - PDF)
Suomi (FI) (590.8 KB - PDF)
svenska (SV) (591.31 KB - PDF)
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)
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I
English (EN) (1.61 MB - PDF)
български (BG) (1.54 MB - PDF)
español (ES) (1.04 MB - PDF)
čeština (CS) (1.53 MB - PDF)
dansk (DA) (1.49 MB - PDF)
Deutsch (DE) (1.5 MB - PDF)
eesti keel (ET) (1.04 MB - PDF)
ελληνικά (EL) (1.1 MB - PDF)
français (FR) (1.04 MB - PDF)
hrvatski (HR) (1.07 MB - PDF)
italiano (IT) (938.56 KB - PDF)
latviešu valoda (LV) (1.08 MB - PDF)
lietuvių kalba (LT) (1.2 MB - PDF)
magyar (HU) (1.07 MB - PDF)
Malti (MT) (1.09 MB - PDF)
Nederlands (NL) (1.04 MB - PDF)
polski (PL) (1.08 MB - PDF)
português (PT) (1.04 MB - PDF)
română (RO) (1.08 MB - PDF)
slovenčina (SK) (1.07 MB - PDF)
slovenščina (SL) (1.08 MB - PDF)
Suomi (FI) (1.04 MB - PDF)
svenska (SV) (1.04 MB - PDF)
Maci : EPAR - Public assessment report : Article-20 procedure
English (EN) (1.33 MB - PDF)
Maci : EPAR - Public assessment report
English (EN) (4.71 MB - PDF)
CHMP summary of positive opinion for Maci
English (EN) (810.17 KB - PDF)