Macugen

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Withdrawn

This medicine's authorisation has been withdrawn

pegaptanib
MedicineHumanWithdrawn

Romanian is available via eTranslation, the European Commission's machine translation service.

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  • 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The European Public Assessment Report (EPAR) for Macugen is updated to indicate that the marketing authorisation is no longer valid.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)

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български (BG) (663.47 KB - PDF)

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español (ES) (596.59 KB - PDF)

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čeština (CS) (637.04 KB - PDF)

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dansk (DA) (596.95 KB - PDF)

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Deutsch (DE) (597.88 KB - PDF)

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eesti (ET) (596.17 KB - PDF)

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ελληνικά (EL) (682.05 KB - PDF)

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français (FR) (599.24 KB - PDF)

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italiano (IT) (649.91 KB - PDF)

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latviešu (LV) (648.04 KB - PDF)

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lietuvių (LT) (602.49 KB - PDF)

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magyar (HU) (636.13 KB - PDF)

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Malti (MT) (647.6 KB - PDF)

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Nederlands (NL) (595.16 KB - PDF)

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polski (PL) (635.92 KB - PDF)

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português (PT) (597.31 KB - PDF)

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română (RO) (602.5 KB - PDF)

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slovenčina (SK) (590.75 KB - PDF)

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slovenščina (SL) (620.21 KB - PDF)

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suomi (FI) (583.77 KB - PDF)

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svenska (SV) (595.25 KB - PDF)

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Product information

Macugen : EPAR - Product Information

English (EN) (832.53 KB - PDF)

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български (BG) (1.47 MB - PDF)

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español (ES) (801.14 KB - PDF)

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čeština (CS) (1.25 MB - PDF)

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dansk (DA) (793.88 KB - PDF)

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Deutsch (DE) (790.46 KB - PDF)

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eesti (ET) (767.96 KB - PDF)

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ελληνικά (EL) (1.61 MB - PDF)

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français (FR) (793.99 KB - PDF)

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hrvatski (HR) (826.96 KB - PDF)

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italiano (IT) (772.63 KB - PDF)

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latviešu (LV) (1.4 MB - PDF)

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lietuvių (LT) (976.35 KB - PDF)

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magyar (HU) (1.23 MB - PDF)

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Malti (MT) (1.42 MB - PDF)

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Nederlands (NL) (872.52 KB - PDF)

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polski (PL) (1.35 MB - PDF)

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português (PT) (765.25 KB - PDF)

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română (RO) (1000.2 KB - PDF)

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slovenčina (SK) (1.24 MB - PDF)

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slovenščina (SL) (1.39 MB - PDF)

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suomi (FI) (821.74 KB - PDF)

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svenska (SV) (774.71 KB - PDF)

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Íslenska (IS) (779.73 KB - PDF)

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norsk (NO) (793.02 KB - PDF)

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Latest procedure affecting product information:IB/0065
20/07/2016
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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).

Macugen : EPAR - All Authorised presentations

English (EN) (457.96 KB - PDF)

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български (BG) (538.8 KB - PDF)

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español (ES) (458.33 KB - PDF)

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čeština (CS) (540.02 KB - PDF)

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dansk (DA) (460.05 KB - PDF)

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Deutsch (DE) (458.67 KB - PDF)

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eesti (ET) (460.41 KB - PDF)

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ελληνικά (EL) (519.4 KB - PDF)

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français (FR) (458.25 KB - PDF)

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italiano (IT) (458.12 KB - PDF)

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latviešu (LV) (539.76 KB - PDF)

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lietuvių (LT) (533.6 KB - PDF)

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magyar (HU) (536.46 KB - PDF)

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Malti (MT) (537.49 KB - PDF)

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Nederlands (NL) (457.9 KB - PDF)

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polski (PL) (541.48 KB - PDF)

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português (PT) (458.34 KB - PDF)

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română (RO) (523 KB - PDF)

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slovenčina (SK) (535.63 KB - PDF)

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slovenščina (SL) (461.58 KB - PDF)

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suomi (FI) (459.56 KB - PDF)

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svenska (SV) (458.3 KB - PDF)

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Macugen : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

English (EN) (477.37 KB - PDF)

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български (BG) (579.31 KB - PDF)

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español (ES) (477.76 KB - PDF)

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čeština (CS) (568.25 KB - PDF)

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dansk (DA) (476.73 KB - PDF)

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Deutsch (DE) (478.44 KB - PDF)

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eesti (ET) (473.23 KB - PDF)

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ελληνικά (EL) (571.1 KB - PDF)

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français (FR) (484.43 KB - PDF)

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italiano (IT) (476.75 KB - PDF)

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latviešu (LV) (576.29 KB - PDF)

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lietuvių (LT) (543.73 KB - PDF)

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magyar (HU) (533.53 KB - PDF)

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Malti (MT) (1.03 MB - PDF)

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Nederlands (NL) (477.91 KB - PDF)

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polski (PL) (573.21 KB - PDF)

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português (PT) (477.16 KB - PDF)

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română (RO) (546.55 KB - PDF)

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slovenčina (SK) (569.93 KB - PDF)

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slovenščina (SL) (561.68 KB - PDF)

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suomi (FI) (476.99 KB - PDF)

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svenska (SV) (477.99 KB - PDF)

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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

Ophthalmologicals

Therapeutic 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)

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Macugen : EPAR - Procedural steps taken before authorisation

English (EN) (482.92 KB - PDF)

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Macugen : EPAR - Scientific Discussion

English (EN) (984.11 KB - PDF)

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