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Anvisa Authorizes Multidose Mounjaro Pen for Brazil

Pharmacy availability hinges on Eli Lilly's pricing decisions, with rollout timing to be set by the company.

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Overview

  • Anvisa approved registration via Resolução-RE nº 1.041, granting Eli Lilly do Brasil permission to commercialize Mounjaro Multidose.
  • The new presentation enables multiple injections from a single pen, replacing the traditional single-use device.
  • The authorization covers six subcutaneous strengths—4.17, 8.33, 12.5, 16.7, 20.8 and 25 mg/mL—under a 24-month registration.
  • Tirzepatide acts on hormones that regulate glucose and appetite, supporting treatment of type 2 diabetes and contributing to weight reduction.
  • Pharmacy rollout depends on company steps such as price setting and launch strategy, and dispensing remains restricted to medical prescription.