Market Announcement. NABOTA® Packaging Update.
Moksha8 Brasil Indústria e Comércio de Medicamentos Ltda. (“M8”), responsible for the exclusive importation and commercialization of NABOTA® (botulinum toxin type A), registered before the Brazilian Health Regulatory Agency under registration number 1.6425.0006, hereby informs the market about the labeling update of NABOTA® packaging commercialized in Brazil.
This update is being implemented in compliance with the new guidelines established by the Brazilian Health Regulatory Agency (Anvisa), following the update of the pharmaceutical labeling regulatory framework published in 2022, whose regulatory deadline for compliance ended in December 2025. Therefore, NABOTA® 100U products from batch X25109 onwards and NABOTA® 200U products from batch X25080F onwards, commercialized by M8 to Rennova as of April 2026, will present visual changes in their packaging and labeling materials, with no changes whatsoever to the product’s formulation, quality, efficacy, safety or origin.
M8 further clarifies that such changes are official, regulatory and mandatory, with no relation whatsoever to product counterfeiting or irregularities. Products with the previous labeling remain fully valid for commercialization and use, with no need for recall, replacement or interruption of use, since the implemented change is exclusively regulatory and related to labeling updates.
In order to preserve the safety of patients and healthcare professionals, we reinforce that NABOTA® products must be acquired exclusively from Innovapharma (Rennova), a sub-distributor accredited and qualified by M8 for the promotion and commercialization of NABOTA® in Brazil for aesthetic purposes, or from other qualified and trusted sub-distributors.
M8 emphasizes that acquiring products through unauthorized channels may compromise product traceability, integrity and safety, in addition to preventing proper technical support and proof of origin.
To assist with the visual identification of the regulatory update, comparative images of the previous and current versions of the NABOTA® packaging are provided below.
We reinforce that both presentations correspond to the original product duly registered before Anvisa, with the changes being limited to packaging and labeling elements.
In case of questions regarding product authenticity or labeling updates, customers may contact:
• Moksha8 Customer Service: 0800 601 9392 | E-mail: br.sac@arceralifesciences.com
• Rennova Customer Service: 0800 642 5858 | E-mail: sac@innovapharma.com
Lastly, M8 reinforces its commitment to the safety, quality, regulatory compliance and traceability of its products, and thanks all partners and healthcare professionals for their understanding.