Regulatory PathRegulatory requirements compared

Active substance

Pegaptanib

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
MACUGENEQ 0.3MG ACID/0.09MLinjectable · intravitrealBAUSCH AND LOMB INCDiscontinued17 Sep 2004

EMA European Union — centrally authorised medicines

Macugen PharmaSwiss Ceska Republika s.r.o · Withdrawn · authorised 31 Jan 2006 · ATC S01LA03

Therapeutic indication (EMA)

Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Safety signals and safety-related labeling changes

All safety entries for pegaptanib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.