The National Health Surveillance Agency (Anvisa) determined this Wednesday (4) the seizure, ban on the distribution and marketing and use of counterfeit units of the drug Humira AC 40 mg (adalimumab), indicated for arthritis.
The batch in question is the 1146607 (fab 05/2021, date 01/2023). The measure was made public through the Resolution-RE 1,413/2022.
The decision came after a statement from the company that owns the registration – AbbVie Farmacêutica Ltda., which notified Anvisa about the falsification of a Humira AC filled syringe. The case remains under investigation by the agency.
Anvisa asks the health services that, if they receive units of the mentioned drug, before using them, they make a careful check of the packaging and the label of the product.
In case of counterfeit units, do not use the product and report the fact immediately to the Agency, preferably through the system news.
How to identify counterfeit lots
When purchasing a package, it is necessary to observe the following differences in relation to the original drug:
- Difference in closing the blister;
- Difference in color of safety marking;
- Differences in color and font size on the blister;
- Different dimensions of packages; and
- Absence of Braille marking on secondary packaging.
syringe color
product packaging
blister closure
about the medicine
According to AbbVie, Humira AC is indicated to reduce signs and symptoms, induce a clinical response and greater clinical remission, inhibit the progression of structural damage, and improve physical capacity in adult patients with rheumatoid arthritis moderate-to-severe active, who had an inadequate response to one or more disease-modifying antirheumatic drugs.
Source: CNN Brasil
