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Infarmed replaces cancer drug in shortage. Here, thousands arrived
Infarmed clarified today that it managed, through the importation with foreign-language labeling, to replace the drug Fluorouracil, used in cancer and whose rupture was notified by the laboratories, with 3,000 packages having already arrived in Portugal.
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País Medicamentos
In response to the Lusa agency, the National Authority of Medicines and Health Products explained that both holders of the Marketing Authorization (AIM) in Portugal -- the Accord and Hikma laboratories -- have been out of stock since mid-April due to increased demand and that there are constraints "in most European countries".
Infarmed's response comes after a news item published today by Jornal de Notícias, according to which the medicine was being "distributed in a limited way, as a mitigation measure, because it was out of stock".
The hospital also clarified that there are patients undergoing alternative therapeutic regimens, since there are other drugs on the market that can be used.
Infarmed told Lusa that, to mitigate the impact of the shortages of this medicine (Fluorouracil 50 mg/ml injectable solution), which has a monthly consumption of approximately 5,000 packages, it asked distributors specialized in importing these medicines to submit requests for Exceptional Use Authorization (AUE) with foreign language labeling.
Through this mechanism, since April 12, 11 AUEs have been granted for this medicine, according to Infarmed, which adds that around 3,000 packages have already arrived in Portugal, with another 6,100 units yet to arrive.
Infarmed guarantees that hospitals are being supplied and should "coordinate with their distributors".
In the information sent to Lusa, the medicines authority also states that the Accord laboratory presentation will be reinstated on June 11, 2024 and the Hikma presentation on July 1, 2024.
However, it adds, "it is possible that these dates may be brought forward by the holders".
Regarding therapeutic adjustments, Infarmed recalls that "they are another possible tool in the event of difficulty in accessing a certain medicine", emphasizing that, in these situations, "the attending physicians are the ones who can best make this adjustment, according to the needs and specificities of their patients".
Read Also: IPO do Porto promotes international summit on oncology and innovation (Portuguese version)
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