Foscan

RSS

temoporfin

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Foscan. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Foscan.

This EPAR was last updated on 18/04/2016

Authorisation details

Product details
Name
Foscan
Agency product number
EMEA/H/C/000318
Active substance
temoporfin
International non-proprietary name (INN) or common name
temoporfin
Therapeutic area (MeSH)
  • Head and Neck Neoplasms
  • Carcinoma, Squamous Cell
Anatomical therapeutic chemical (ATC) code
L01XD05
Publication details
Marketing-authorisation holder
Biolitec Pharma Ltd
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
23/10/2001
Contact address
Otto-Schott-Str. 15
07745 Jena
Germany

Product information

28/03/2016 Foscan - EMEA/H/C/000318 - IB/0041/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy.

Assessment history

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