Macugen
Withdrawn
This medicine's authorisation has been withdrawn
pegaptanib
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 17 December 2018, the European Commission withdrew the marketing authorisation for Macugen (pegaptanib sodium) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, PharmaSwiss Ceska Republika s.r.o, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Macugen was granted marketing authorisation in the EU on 31 January 2006 for the treatment of neovascular (wet) macular degeneration (AMD).
The marketing authorisation was initially valid for a 5- year period. It was renewed for an additional 5-year period in 2010 and granted unlimited validity in 2015. The product had not been marketed in the EU since 1 January 2019.
The European Public Assessment Report (EPAR) for Macugen is updated to indicate that the marketing authorisation is no longer valid.
Macugen : EPAR - Summary for the public
English (EN) (520.99 KB - PDF)
First published: Last updated:
български (BG) (663.47 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
español (ES) (596.59 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
čeština (CS) (637.04 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
dansk (DA) (596.95 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
Deutsch (DE) (597.88 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
eesti keel (ET) (596.17 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
ελληνικά (EL) (682.05 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
français (FR) (599.24 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
italiano (IT) (649.91 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
latviešu valoda (LV) (648.04 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
lietuvių kalba (LT) (602.49 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
magyar (HU) (636.13 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
Malti (MT) (647.6 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
Nederlands (NL) (595.16 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
polski (PL) (635.92 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
português (PT) (597.31 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
română (RO) (602.5 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
slovenčina (SK) (590.75 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
slovenščina (SL) (620.21 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
Suomi (FI) (583.77 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
svenska (SV) (595.25 KB - PDF)
First published: 31/05/2007Last updated: 27/06/2019
Product information
Macugen : EPAR - Product Information
English (EN) (832.53 KB - PDF)
First published: Last updated:
български (BG) (1.47 MB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
español (ES) (801.14 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
čeština (CS) (1.25 MB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
dansk (DA) (793.88 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
Deutsch (DE) (790.46 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
eesti keel (ET) (767.96 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
ελληνικά (EL) (1.61 MB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
français (FR) (793.99 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
hrvatski (HR) (826.96 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
íslenska (IS) (779.73 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
italiano (IT) (772.63 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
latviešu valoda (LV) (1.4 MB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
lietuvių kalba (LT) (976.35 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
magyar (HU) (1.23 MB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
Malti (MT) (1.42 MB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
Nederlands (NL) (872.52 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
norsk (NO) (793.02 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
polski (PL) (1.35 MB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
português (PT) (765.25 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
română (RO) (1000.2 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
slovenčina (SK) (1.24 MB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
slovenščina (SL) (1.39 MB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
Suomi (FI) (821.74 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
svenska (SV) (774.71 KB - PDF)
First published: 03/08/2009Last updated: 27/06/2019
Latest procedure affecting product information:
IB/0065
20/07/2016
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).
Macugen : EPAR - All Authorised presentations
English (EN) (457.96 KB - PDF)
First published: Last updated:
български (BG) (538.8 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
español (ES) (458.33 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
čeština (CS) (540.02 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
dansk (DA) (460.05 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
Deutsch (DE) (458.67 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
eesti keel (ET) (460.41 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
ελληνικά (EL) (519.4 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
français (FR) (458.25 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
italiano (IT) (458.12 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
latviešu valoda (LV) (539.76 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
lietuvių kalba (LT) (533.6 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
magyar (HU) (536.46 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
Malti (MT) (537.49 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
Nederlands (NL) (457.9 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
polski (PL) (541.48 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
português (PT) (458.34 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
română (RO) (523 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
slovenčina (SK) (535.63 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
slovenščina (SL) (461.58 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
Suomi (FI) (459.56 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
svenska (SV) (458.3 KB - PDF)
First published: 05/02/2008Last updated: 27/06/2019
Macugen : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
English (EN) (477.37 KB - PDF)
First published: Last updated:
български (BG) (579.31 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
español (ES) (477.76 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
čeština (CS) (568.25 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
dansk (DA) (476.73 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
Deutsch (DE) (478.44 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
eesti keel (ET) (473.23 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
ελληνικά (EL) (571.1 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
français (FR) (484.43 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
italiano (IT) (476.75 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
latviešu valoda (LV) (576.29 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
lietuvių kalba (LT) (543.73 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
magyar (HU) (533.53 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
Malti (MT) (1.03 MB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
Nederlands (NL) (477.91 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
polski (PL) (573.21 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
português (PT) (477.16 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
română (RO) (546.55 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
slovenčina (SK) (569.93 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
slovenščina (SL) (561.68 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
Suomi (FI) (476.99 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
svenska (SV) (477.99 KB - PDF)
First published: 13/07/2007Last updated: 27/06/2019
Product details
- Name of medicine
- Macugen
- Active substance
- pegaptanib
- International non-proprietary name (INN) or common name
- pegaptanib
- Therapeutic area (MeSH)
- Wet Macular Degeneration
- Anatomical therapeutic chemical (ATC) code
- S01LA03
Pharmacotherapeutic group
OphthalmologicalsTherapeutic indication
Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).
Authorisation details
- EMA product number
- EMEA/H/C/000620
- Marketing authorisation holder
- PharmaSwiss Ceska Republika s.r.o
Jankovcova 1569/2c
Lighthouse
17000 Prague 7
Czech Republic - Marketing authorisation issued
- 31/01/2006
- Revision
- 15
Assessment history
Macugen : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (688.92 KB - PDF)
First published: Last updated:
More information on Macugen
Topics
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