Panretin

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Withdrawn

This medicine's authorisation has been withdrawn

alitretinoin
MedicineHumanWithdrawn

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 1 January 2021, the European Commission withdrew the marketing authorisation for Panretin (SRD) (alitretinoin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Amdipharm Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Panretin (SRD) was granted marketing authorisation in the EU on 11 October 2000 for treatment of cutaneous lesions in patients with AIDS-related Kaposi’s sarcoma (KS). The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2005. It was then granted unlimited validity in 2010. 

The European Public Assessment Report (EPAR) for Panretin (SRD) is updated to indicate that the marketing authorisation is no longer valid.

Panretin : EPAR - Medicine overview

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Product information

Panretin : EPAR - Product Information

English (EN) (770.77 KB - PDF)

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български (BG) (1.36 MB - PDF)

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eesti (ET) (768.31 KB - PDF)

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ελληνικά (EL) (1.34 MB - PDF)

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Latest procedure affecting product information:IAIN/0045
24/01/2019
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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

English (EN) (620.96 KB - PDF)

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български (BG) (670.87 KB - PDF)

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español (ES) (621.3 KB - PDF)

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čeština (CS) (650.02 KB - PDF)

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dansk (DA) (622.59 KB - PDF)

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Deutsch (DE) (620.46 KB - PDF)

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eesti (ET) (621.29 KB - PDF)

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ελληνικά (EL) (661.55 KB - PDF)

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français (FR) (620.86 KB - PDF)

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italiano (IT) (619.92 KB - PDF)

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magyar (HU) (657.79 KB - PDF)

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Malti (MT) (662.45 KB - PDF)

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Nederlands (NL) (620.27 KB - PDF)

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português (PT) (621.46 KB - PDF)

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română (RO) (637.34 KB - PDF)

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slovenčina (SK) (650.02 KB - PDF)

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slovenščina (SL) (645.35 KB - PDF)

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suomi (FI) (619.4 KB - PDF)

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svenska (SV) (628.43 KB - PDF)

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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

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

English (EN) (634.61 KB - PDF)

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

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

Adopted Reference Number: EMA/254364/2018

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

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Panretin : EPAR - Procedural steps taken before authorisation

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Panretin : EPAR - Scientific Discussion

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