Panretin

Withdrawn

This medicine's authorisation has been withdrawn

alitretinoin

Overview

The marketing authorisation for Panretin has been withdrawn at the request of the marketing-authorisation holder.

Panretin : EPAR - Medicine overview

Product information

Panretin : EPAR - Product Information

Latest procedure affecting product information: IAIN/0045

24/01/2019

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).

Panretin : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Panretin
• Active substance:
  alitretinoin
• International non-proprietary name (INN) or common name:
  alitretinoin
• Therapeutic area (MeSH):
  Sarcoma, Kaposi
• Anatomical therapeutic chemical (ATC) code:
  L01XX22

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000279
• Marketing authorisation holder:
  Eisai GmbH

  Eisai GmbH; Edmund-Rumpler-Strasse 3; 60549 Frankfurt am Main; Germany

• Marketing authorisation issued:
  11/10/2000
• Revision:
  17

Assessment history

Changes since initial authorisation of medicine

Panretin : EPAR - Procedural steps taken and scientific information after authorisation

Panretin : EPAR - Divergent position(s) - Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data

Panretin-H-A-31-1446-C-000279-0037 : EPAR - Assessment Report

AdoptedReference Number: EMA/254364/2018

Panretin : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Panretin : EPAR - Procedural steps taken before authorisation

Panretin : EPAR - Scientific Discussion