Macugen

RSS
Withdrawn

This medicine's authorisation has been withdrawn

pegaptanib
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Macugen has been withdrawn at the request of the marketing-authorisation holder.

Macugen : EPAR - Summary for the public

English (EN) (520.99 KB - PDF)

First published: Last updated:
View

български (BG) (663.47 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

español (ES) (596.59 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

čeština (CS) (637.04 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

dansk (DA) (596.95 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

Deutsch (DE) (597.88 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

eesti keel (ET) (596.17 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

ελληνικά (EL) (682.05 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

français (FR) (599.24 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

italiano (IT) (649.91 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

latviešu valoda (LV) (648.04 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

lietuvių kalba (LT) (602.49 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

magyar (HU) (636.13 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

Malti (MT) (647.6 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

Nederlands (NL) (595.16 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

polski (PL) (635.92 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

português (PT) (597.31 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

română (RO) (602.5 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

slovenčina (SK) (590.75 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

slovenščina (SL) (620.21 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

Suomi (FI) (583.77 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

svenska (SV) (595.25 KB - PDF)

First published: 31/05/2007Last updated: 27/06/2019
View

Product information

Macugen : EPAR - Product Information

English (EN) (832.53 KB - PDF)

First published: Last updated:
View

български (BG) (1.47 MB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

español (ES) (801.14 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

čeština (CS) (1.25 MB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

dansk (DA) (793.88 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

Deutsch (DE) (790.46 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

eesti keel (ET) (767.96 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

ελληνικά (EL) (1.61 MB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

français (FR) (793.99 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

hrvatski (HR) (826.96 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

íslenska (IS) (779.73 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

italiano (IT) (772.63 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

latviešu valoda (LV) (1.4 MB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

lietuvių kalba (LT) (976.35 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

magyar (HU) (1.23 MB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

Malti (MT) (1.42 MB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

Nederlands (NL) (872.52 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

norsk (NO) (793.02 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

polski (PL) (1.35 MB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

português (PT) (765.25 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

română (RO) (1000.2 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

slovenčina (SK) (1.24 MB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

slovenščina (SL) (1.39 MB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

Suomi (FI) (821.74 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View

svenska (SV) (774.71 KB - PDF)

First published: 03/08/2009Last updated: 27/06/2019
View
Latest procedure affecting product information: IB/0065
20/07/2016
icon globe

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:
View

български (BG) (538.8 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

español (ES) (458.33 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

čeština (CS) (540.02 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

dansk (DA) (460.05 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

Deutsch (DE) (458.67 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

eesti keel (ET) (460.41 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

ελληνικά (EL) (519.4 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

français (FR) (458.25 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

italiano (IT) (458.12 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

latviešu valoda (LV) (539.76 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

lietuvių kalba (LT) (533.6 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

magyar (HU) (536.46 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

Malti (MT) (537.49 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

Nederlands (NL) (457.9 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

polski (PL) (541.48 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

português (PT) (458.34 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

română (RO) (523 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

slovenčina (SK) (535.63 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

slovenščina (SL) (461.58 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

Suomi (FI) (459.56 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

svenska (SV) (458.3 KB - PDF)

First published: 05/02/2008Last updated: 27/06/2019
View

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

English (EN) (477.37 KB - PDF)

First published: Last updated:
View

български (BG) (579.31 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

español (ES) (477.76 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

čeština (CS) (568.25 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

dansk (DA) (476.73 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

Deutsch (DE) (478.44 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

eesti keel (ET) (473.23 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

ελληνικά (EL) (571.1 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

français (FR) (484.43 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

italiano (IT) (476.75 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

latviešu valoda (LV) (576.29 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

lietuvių kalba (LT) (543.73 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

magyar (HU) (533.53 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

Malti (MT) (1.03 MB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

Nederlands (NL) (477.91 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

polski (PL) (573.21 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

português (PT) (477.16 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

română (RO) (546.55 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

slovenčina (SK) (569.93 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

slovenščina (SL) (561.68 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

Suomi (FI) (476.99 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

svenska (SV) (477.99 KB - PDF)

First published: 13/07/2007Last updated: 27/06/2019
View

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)

First published: Last updated:
View

Macugen : EPAR - Procedural steps taken before authorisation

English (EN) (482.92 KB - PDF)

First published: Last updated:
View

Macugen : EPAR - Scientific Discussion

English (EN) (984.11 KB - PDF)

First published: Last updated:
View

More information on Macugen

Public statement on Macugen : Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/335559/2019

English (EN) (112.9 KB - PDF)

First published:
View
This page was last updated on

Share this page

Back to top