Infarmed news in Portugal

Infarmed calls for the reporting of suspected adverse drug reactions

Infarmed warns of the importance for citizens to be aware of potential adverse reactions, advising them to consult the medicine's patient information leaflet.

Tilray Medical wins Portugal approval. Tilray Brands stock is valued at USD 314.2 million

ad-hoc-news.de25 Oct

Epidermolysis bullosa: Manufacturer of Vyjuvek has submitted the funding application for the medication to Infarmed

The request was submitted last Monday

Injectable Nolotil will be discontinued in Portugal from February 2027

The sale of injectable Nolotil will be phased out in Portugal starting in February 2027.

Jornal SOL16 Oct

Weight-loss drugs trigger one suspected adverse reaction report per day

Infarmed has received an average of one notification per day this year regarding suspected adverse reactions to weight-loss and diabetes medications, such as vomiting, diarrhoea, and hair loss, totalling 266 reports as of 21 September.

Portugal receives daily complaints regarding weight-loss medicines

Home News Portugal receives daily complaints regarding weight-loss medicines Portugal receives daily complaints regarding weight-loss medicines Infarmed has recorded a daily average of reports of side effects related to medicines for diabetes and weight loss. By Bruno G.

Infarmed prohibits the export of 52 medicines

The list includes antidepressants, painkillers, antibiotics, and drugs indicated for cancer treatment.

Oncology: Medicines take years to reach patients

Data indicate that between 2020 and 2025, 57 applications for oncology drugs were submitted to Infarmed, with 26 new drugs and 37 early access programmes being approved.

Salofalk batch recall: Infarmed halts distribution but urges patients to continue treatment

The National Authority of Medicines (Infarmed) has ordered the immediate withdrawal of a batch of the drug Salofalk, used for inflammatory bowel diseases, due to a technical non-compliance in packaging serialization. Despite the sales ban and mandatory recall, the regulator warns patients not to stop treatment abruptly, advising them to consult their doctor for an alternative. The recall affects batch L25428A (Mesalazine 3000mg, 60 sachets). The issue is limited to digital verification and serialization, with no reports of chemical quality issues or contamination. Infarmed has also recently suspended sales of Sertraline toLife batches, while other reports highlight oncology patients facing treatment interruptions due to stock shortages.

Notifications of adverse drug reactions rose to 12,349 in 2025

The National Pharmacovigilance System (SNF) received 12,349 reports of suspected adverse drug reactions in 2025, a 9.2% increase from 2024. Infarmed attributes this rise to greater engagement from healthcare professionals and the public. While 59.1% of cases were classified as serious, officials note this is below the European average of 75% and reflects a higher tendency to report impactful events. The data, which includes reports from the RAM Portal, pharmaceutical industry, and scientific literature, shows that general disorders and administration site conditions were the most frequently reported reactions. Infarmed continues to promote awareness to combat under-reporting, with the highest notification rates concentrated in the Lisbon and Porto regions due to population density and healthcare infrastructure.

Supply issues lead Infarmed to halt export of medication used for psychiatric conditions

The regulator anticipates constraints until the end of the year

Infarmed: Generic drug sales increased by 7.7%

Infarmed confirms a rise in sales and expenditure on generics, but their share of the total market has declined. The cause, they state, is the growth of non-generic medications.

How a fake medicinal cannabis network deceived Infarmed

The Judicial Police dismantled a drug trafficking network with a laboratory in Abrantes, suppliers in Malaysia, clients in the Netherlands, and revenues of 40 million euros. Infarmed's oversight was criticised by the Public Prosecutor's Office.

Government strengthens oversight of medicinal cannabis

The revision of the medicinal cannabis decree-law and the strengthening of Infarmed are among the measures announced following the indictment of 24 defendants linked to the sector.

Infarmed suspends burn and sunburn product in Portugal

The Portuguese National Authority of Medicines and Health Products has issued a suspension for a specific product used to treat burns and sunburns.

New in Seixal22 Jun

Infarmed orders the withdrawal of FBeauty cosmetic products from the market

Infarmed has ordered the immediate suspension of sales and the withdrawal from the market of more than 50 FBeauty cosmetic products for failing to meet required legal standards, according to an information circular from the national medicines authority.

Medicinal cannabis trafficking ring used Infarmed loopholes, prosecutors allege

A criminal network allegedly exploited weaknesses in Portugal’s medicinal cannabis licensing system to divert tonnes of cannabis onto the black market, according to prosecutors investigating one of the country’s largest The post Medicinal cannabis trafficking ring used Infarmed loopholes, prosecutors allege appeared first on Portugal Resident.

Infarmed lacked the human resources to inspect tonnes of medicinal cannabis, Public Prosecutor concludes

A medicinal cannabis network exploited weaknesses in the medicines authority, which only performed administrative checks on legal documentation for exports to African countries. Until 2024, there was only one technician and one administrative staff member to carry out this work.

Infarmed orders the withdrawal of FBeauty cosmetic products from the market

Infarmed has ordered the immediate suspension of sales and the withdrawal from the market of more than 50 FBeauty cosmetic products for failing to meet required legal standards, according to an information circular from the national medicines authority. The decision follows a complaint sent to Infarmed which triggered an inspection of the products.

Infarmed orders the withdrawal of over 50 cosmetic products from the market

It also advises consumers who possess any of these products not to use them

Infarmed orders withdrawal of product for relief of burns and skin irritation from the market

Infarmed has ordered the immediate suspension of sales and the withdrawal from the market of Calmidine, indicated for the relief of superficial burns, sunburns, and skin irritations, due to it being improperly classified as a cosmetic product. The National Authority of Medicines and Health Products (Infarmed) concluded, following a market surveillance action and analysis of available information, that the product Calmidine is improperly classified from a regulatory standpoint as a cosmetic. Infarmed explains in an informative circular that the product from the company MedNet GmbH, based in Germany, does not meet the requirements established by the European Parliament and Council regulation on cosmetic products. The authority urges entities and consumers in possession of this product not to distribute or use it.

Infarmed orders the withdrawal of a product for the relief of burns and skin irritation from the market

The national medicines authority warns that Calmidine is on the market improperly classified as a cosmetic product

Tromalyt, for cardiovascular diseases, out of stock

The medication Tromalyt is out of stock due to manufacturing reasons until 31/07/2026, according to Infarmed. Substitution will be temporarily permitted for prescriptions already issued and valid.

Tromalyt medication for cardiovascular disease prevention out of stock

Infarmed has limited the supply to one month of treatment

Cancer. Infarmed refuses innovative treatment for women

An innovative drug would allow for an increase in the life expectancy of women with the most aggressive form of breast cancer. Despite being in a free experimental programme, Infarmed refused it.

Drug submission and approval takes almost 2 years

The average time for submission after European authorisation was 272 days, and the evaluation time by Infarmed was 332 days. On average, the process takes almost two years between submission and completion.