Panretin

RSS

alitretinoin

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

Overview

An overview of Panretin and why it is authorised in the EU

Panretin is a medicine used to treat the skin lesions seen in AIDS patients with Kaposi’s sarcoma (a type of skin cancer). Panretin is used when:

  • the skin is not broken and the lesions are not swollen,
  • the lesions have not responded to HIV treatment,
  • other treatments (radiotherapy or chemotherapy) are not suitable, and
  • treatment for visceral (internal) Kaposi’s sarcoma is not needed.
This EPAR was last updated on 02/07/2018

Authorisation details

Product details
Name
Panretin
Agency product number
EMEA/H/C/000279
Active substance
alitretinoin
International non-proprietary name (INN) or common name
alitretinoin
Therapeutic area (MeSH)
Sarcoma, Kaposi
Anatomical therapeutic chemical (ATC) code
L01XX22
Publication details
Marketing-authorisation holder
Eisai Ltd
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
11/10/2000
Contact address
European Knowledge Centre
Mosquito Way
Hatfield
Hertfordshire
AL10 9SN
United Kingdom

Product information

21/06/2018 Panretin - EMEA/H/C/000279 - A31/0037

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

Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with acquired-immune-deficiency-syndrome (AIDS)-related Kaposi's sarcoma (KS) when:

  • lesions are not ulcerated or lymphoedematous, and;
  • treatment of visceral KS is not required, and;
  • lesions are not responding to systemic antiretroviral therapy, and;
  • radiotherapy or chemotherapy are not appropriate.

Assessment history

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