Macugen
Withdrawn
This medicine's authorisation has been withdrawn
pegaptanib
MedicineHumanWithdrawn
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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The European Public Assessment Report (EPAR) for Macugen is updated to indicate that the marketing authorisation is no longer valid.
Product information
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).
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).
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