- 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The marketing authorisation for Macugen has been withdrawn at the request of the marketing-authorisation holder.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)
български (BG) (663.47 KB - PDF)
español (ES) (596.59 KB - PDF)
čeština (CS) (637.04 KB - PDF)
dansk (DA) (596.95 KB - PDF)
Deutsch (DE) (597.88 KB - PDF)
eesti keel (ET) (596.17 KB - PDF)
ελληνικά (EL) (682.05 KB - PDF)
français (FR) (599.24 KB - PDF)
italiano (IT) (649.91 KB - PDF)
latviešu valoda (LV) (648.04 KB - PDF)
lietuvių kalba (LT) (602.49 KB - PDF)
magyar (HU) (636.13 KB - PDF)
Malti (MT) (647.6 KB - PDF)
Nederlands (NL) (595.16 KB - PDF)
polski (PL) (635.92 KB - PDF)
português (PT) (597.31 KB - PDF)
română (RO) (602.5 KB - PDF)
slovenčina (SK) (590.75 KB - PDF)
slovenščina (SL) (620.21 KB - PDF)
Suomi (FI) (583.77 KB - PDF)
svenska (SV) (595.25 KB - PDF)
Product information
Macugen : EPAR - Product Information
English (EN) (832.53 KB - PDF)
български (BG) (1.47 MB - PDF)
español (ES) (801.14 KB - PDF)
čeština (CS) (1.25 MB - PDF)
dansk (DA) (793.88 KB - PDF)
Deutsch (DE) (790.46 KB - PDF)
eesti keel (ET) (767.96 KB - PDF)
ελληνικά (EL) (1.61 MB - PDF)
français (FR) (793.99 KB - PDF)
hrvatski (HR) (826.96 KB - PDF)
íslenska (IS) (779.73 KB - PDF)
italiano (IT) (772.63 KB - PDF)
latviešu valoda (LV) (1.4 MB - PDF)
lietuvių kalba (LT) (976.35 KB - PDF)
magyar (HU) (1.23 MB - PDF)
Malti (MT) (1.42 MB - PDF)
Nederlands (NL) (872.52 KB - PDF)
norsk (NO) (793.02 KB - PDF)
polski (PL) (1.35 MB - PDF)
português (PT) (765.25 KB - PDF)
română (RO) (1000.2 KB - PDF)
slovenčina (SK) (1.24 MB - PDF)
slovenščina (SL) (1.39 MB - PDF)
Suomi (FI) (821.74 KB - PDF)
svenska (SV) (774.71 KB - 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).
Macugen : EPAR - All Authorised presentations
English (EN) (457.96 KB - PDF)
български (BG) (538.8 KB - PDF)
español (ES) (458.33 KB - PDF)
čeština (CS) (540.02 KB - PDF)
dansk (DA) (460.05 KB - PDF)
Deutsch (DE) (458.67 KB - PDF)
eesti keel (ET) (460.41 KB - PDF)
ελληνικά (EL) (519.4 KB - PDF)
français (FR) (458.25 KB - PDF)
italiano (IT) (458.12 KB - PDF)
latviešu valoda (LV) (539.76 KB - PDF)
lietuvių kalba (LT) (533.6 KB - PDF)
magyar (HU) (536.46 KB - PDF)
Malti (MT) (537.49 KB - PDF)
Nederlands (NL) (457.9 KB - PDF)
polski (PL) (541.48 KB - PDF)
português (PT) (458.34 KB - PDF)
română (RO) (523 KB - PDF)
slovenčina (SK) (535.63 KB - PDF)
slovenščina (SL) (461.58 KB - PDF)
Suomi (FI) (459.56 KB - PDF)
svenska (SV) (458.3 KB - PDF)
Macugen : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
English (EN) (477.37 KB - PDF)
български (BG) (579.31 KB - PDF)
español (ES) (477.76 KB - PDF)
čeština (CS) (568.25 KB - PDF)
dansk (DA) (476.73 KB - PDF)
Deutsch (DE) (478.44 KB - PDF)
eesti keel (ET) (473.23 KB - PDF)
ελληνικά (EL) (571.1 KB - PDF)
français (FR) (484.43 KB - PDF)
italiano (IT) (476.75 KB - PDF)
latviešu valoda (LV) (576.29 KB - PDF)
lietuvių kalba (LT) (543.73 KB - PDF)
magyar (HU) (533.53 KB - PDF)
Malti (MT) (1.03 MB - PDF)
Nederlands (NL) (477.91 KB - PDF)
polski (PL) (573.21 KB - PDF)
português (PT) (477.16 KB - PDF)
română (RO) (546.55 KB - PDF)
slovenčina (SK) (569.93 KB - PDF)
slovenščina (SL) (561.68 KB - PDF)
Suomi (FI) (476.99 KB - PDF)
svenska (SV) (477.99 KB - PDF)
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)
More information on Macugen
Public statement on Macugen : Withdrawal of the marketing authorisation in the European Union
English (EN) (112.9 KB - PDF)