Is Porfimer approved by the US FDA?

Drugs@FDA lists 2 application product lines for Porfimer, including PHOTOFRIN (Prescription); PHOTOFRIN (Prescription).

Is Porfimer authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Porfimer.

Are there safety signals or safety updates for Porfimer?

US FDA: 2 entries (latest 2020-01-01).

Active substance

Porfimer

US FDA 2
EMA 1
Safety 2

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
PHOTOFRIN	75MG/VIAL	injectable · injection	PINNACLE BIOLGS	Prescription	27 Dec 1995
PHOTOFRIN	75MG/VIAL	injectable · injection	AXCAN SCANDIPHARM	Prescription	1 Aug 2003

EMA European Union — centrally authorised medicines

PhotoBarr Pinnacle Biologics B.V. · Withdrawn · authorised 25 Mar 2004 · ATC L01XD01

Therapeutic indication (EMA)

Photodynamic therapy (PDT) with PhotoBarr is indicated for: Ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO)

Safety signals and safety-related labeling changes

US FDA 1 Jan 2020 PHOTOFRIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
US FDA 1 Jan 2020 PHOTOFRIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations

All safety entries for porfimer →

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.