Regulatory PathRegulatory requirements compared

Active substance

Alitretinoin

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
PANRETINEQ 0.1% BASEgel · topicalADVANZ PHARMAPrescription2 Feb 1999

EMA European Union — centrally authorised medicines

Panretin Eisai GmbH · Withdrawn · authorised 11 Oct 2000 · ATC L01XX22

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
HANZEMA0247743210 MGCAPSULE · ORALDR. REDDY'S LABORATORIES INC
HANZEMA0247744030 MGCAPSULE · ORALDR. REDDY'S LABORATORIES INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffAlitretinoin 10mg capsules£493.7230 capsule1 Oct 2026
NHS Drug TariffAlitretinoin 30mg capsules£493.7230 capsule1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 17 Nov 2025 PANRETIN — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for alitretinoin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.