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European Public Assessment Report (EPAR) for Panretin (SRD) is updated to indicate that the marketing authorisation is no longer valid.
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.
Therapeutic Area (MeSH)
ATC Code
L01XX22
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Panretin
Medicine Name
Panretin
Aliases
N/ANo risk management plan link.
