Panretin
Withdrawn
This medicine's authorisation has been withdrawn
alitretinoin
MedicineHumanWithdrawn
- 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European Public Assessment Report (EPAR) for Panretin (SRD) is updated to indicate that the marketing authorisation is no longer valid.
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).
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 agentsTherapeutic 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.
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