Market Announcement. Labeling Update.
Moksha8 Brasil Indústria e Comércio de Medicamentos Ltda. (“M8”) hereby announces an
update to the labeling of product packaging sold in Brazil.
This change is being made in compliance with the new guidelines established by the National Health Surveillance Agency
(Anvisa), in accordance with the update to the regulatory framework for drug labeling published
in December 2022, for which the regulatory compliance deadline was December 2025.
Consequently, future batches imported and marketed in the country will feature visual changes
to their packaging and labeling materials, without any changes to the formulation,
quality, efficacy, safety, or origin of the products.
M8 further clarifies that these changes are official, regulatory, and mandatory, and are in no way
related to product counterfeiting or irregularities. Products with the previous labeling
remain fully valid for sale and use, and there is no need
for a recall, replacement, or discontinuation of use, since the change made is
exclusively regulatory and related to an update in labeling.
If you have any questions about the authenticity of our products or labeling updates, customers
can contact:
- Moksha8 Customer Service: 0800 601 9392 | Email: br.sac@arceralifesciences.com
Finally, M8 reaffirms its commitment to the safety, quality, regulatory compliance, and
traceability of its products, and thanks all partners and professionals in the
industry for their understanding.