Portugal with 'stock' and immediate access to remdesivir medicine

in News · 02-07-2020 18:08:00 · 0 Comments

Infarmed assured on 1 July that Portugal has 'stock' available and reserves for immediate use of the remdesivir drug, which has been used against covid-19, and that the laboratory does not anticipate constraints on its access to Portuguese patients.

"We can inform you that there is 'stock' available of the remdesivir medicine, according to the allocations that have been made to our country, constituting a first reservation that guarantees immediate access to the medicine", said, in a statement, the National Authority of the Medicines and Health Products.

Infarmed also revealed that, after contacting the laboratory that holds the remdesivir drug, it confirmed that "it anticipates that there will be no constraint on access to treatment by Portuguese patients, with the guarantee of joint monitoring of the situation".

The medicine authority in Portugal explains that remdesivir obtained a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), "whose authorisation should be granted soon by the European Commission".

The opinion issued has the therapeutic indication for the treatment of covid-19 in adults and adolescents from 12 years old with pneumonia and who require supplemental oxygen, he adds.

"This authorisation will be conditional because confirmatory results are still awaited", underlines the statement.

The note also emphasises that this medicine "was always available in Portugal, even before having the aforementioned conditional authorization, through requests for Authorisation for Exceptional Use, as soon as the attending physicians understood it".

And it guarantees that "all requests for access to the medicine by national hospitals have been granted".

The European Commission is, in turn, negotiating with the producing company the purchase and reservation of the remdesivir medicine.

“Commissioner Kyriakides (Stella Kyriakides, from the area of Health and Food Safety) has been in multiple conversations with the producer, Gilead, including regarding her production capacity. The Commission is also currently in negotiations with Gilead to reserve doses of Remdesivir. Given the confidentiality of these talks, we cannot share any more details at this time,” Stefan de Keersmaecker, spokesman for the European Commission, responsible for public health, told Lusa.

The information comes in connection with the announcement by the United States that they bought from the company Gilead Sciences practically the entire reserve for three months of the remdesivir drug, the first approved in the country for the treatment of covid-19.

In a statement, the US health department said it "ensured more than 500,000 drug treatment cycles for American hospitals by September", which is equivalent to "100 percent of Gilead's expected production for July (94.200 cycles), 90 percent of production in August (174,900 cycles) and 90 percent of production in September (232,800 cycles), in addition to a budget for clinical trials".


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