Notice of Registration Cancellation for the Drug Ultraproct LDO (fluocortolone pivalate, lidocaine hydrochloride)
In accordance with Resolution RDC No. 18/2014, issued by Anvisa (the Brazilian Health Regulatory Agency), Moksha8 Brasil Indústria e Comércio de Medicamentos Ltda, headquartered at Avenida Ibirapuera, 2332, Tower I, 13th floor, Indianópolis, São Paulo/SP, registered with the CNPJ under No. 07.591.326/0001-80, hereby informs that on October 21, 2025, it requested from the Health Authority, to cancel the registration, via file 1401189/25-3, of the drug ULTRAPROCT LDO (fluocortolone pivalate, lidocaine hydrochloride).
The product was undergoing a change in the manufacturing site for the finished product, with the manufacturer being replaced from LEO Pharma Manufacturing Italy S.R.L. to Temmler Italia S.r.L. However, considering the time required to approve these changes, the company determined that it would not be possible to obtain approval and implement the changes before a potential shortage of the product in the Brazilian market beginning in October 2025 and, therefore, decided to request the cancellation of the product’s registration. With a focus on the well-being of Brazilian patients, it is important to note that, despite the cancellation of ULTRAPROCT LDO’s registration, there are therapeutic alternatives available on the domestic market with the same indication and therapeutic class. Thus, patients will not be left without care.
If you have any questions or need additional information, our team is available to assist you by phone at 0800 601 9392 or by email at br.sac@arceralifesciences.com.