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EMA: No change to product information for breast cancer medicine Tyverb following re-assessment of data

The product information for Tyverb, a breast cancer medicine, will continue to state that no data are available on the effectiveness of Tyverb used together with an aromatase inhibitor compared with trastuzumab used with an aromatase inhibitor in patients previously treated with trastuzumab. In July 2018, results of a study involving women with ‘HR+/HER2+’ breast cancer and [...]

2020-03-31T21:07:09+00:0031.03.2020|Pharmacovigilance, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020

Eight new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its March 2020 meeting. In line with EMA’s measures to limit the spread of COVID-19, the meeting was held virtually. The Committee recommended granting a conditional marketing authorisation for Zolgensma* (onasemnogene abeparvovec), an advanced therapy medicinal product (ATMP) for the treatment of babies and young children [...]

EMA: Restrictions in use of cyproterone due to meningioma risk

On 13 February 2020, EMA’s safety committee (PRAC) recommended that medicines with daily doses of 10 mg or more of cyproterone should only be used for androgen-dependent conditions such as hirsutism (excessive hair growth), alopecia (hair loss), acne and seborrhoea (excessively oily skin) once other treatment options, including treatment with lower doses, have failed. Once higher [...]

2020-03-30T17:56:57+00:0030.03.2020|Pharmacovigilance|

EMA: No change is needed in use of direct oral anticoagulants following EMA-funded study

No change to the conditions of use of the direct oral anticoagulants Eliquis (apixaban), Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban) is needed following a review of the results of a European study of real-world data for these medicines. The study, commissioned by EMA and using real-world data from Denmark, France, Germany, Spain, the Netherlands and [...]

2020-03-30T17:54:07+00:0030.03.2020|Pharmacovigilance|

EMA: Recommendations to restrict use of fosfomycin antibiotics

EMA has recommended that fosfomycin medicines given by infusion (drip) into a vein should only be used to treat serious infections when other antibiotic treatments are not suitable. Fosfomycin medicines given by mouth can continue to be used to treat uncomplicated bladder infections in women and adolescent girls. They can also be used to prevent [...]

2020-03-30T17:49:39+00:0030.03.2020|Pharmacovigilance|

EMA: Benefits of medicines containing combination of methocarbamol and paracetamol continue to outweigh risks

EMA has concluded that the benefits of medicines containing methocarbamol and paracetamol continue to outweigh their risks in the short-term treatment of painful muscle spasms. EMA’s review was started because recent publications1,2,had raised questions about the effectiveness of the combination of these substances at treating conditions such as low back pain in the doses at [...]

2020-03-29T21:10:32+00:0029.03.2020|Pharmacovigilance|

(Cas) La AEMPS recuerda los riesgos de comprar medicamentos falsificados para el tratamiento del COVID-19 a través de webs ilegales

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. Únicamente deben comprarse medicamentos sin prescripción médica en oficinas de farmacia autorizadas, que estén registradas para la venta online. No existe [...]

2020-03-27T20:14:57+00:0027.03.2020|Pharmacovigilance|

EMA – COVID-19: Beware of falsified medicines from unregistered websites

EMA is urging the general public not to buy medicines from unauthorised websites and other vendors aiming to exploit fears and concerns during the ongoing pandemic of coronavirus disease (COVID-19). Vendors may claim that their products can treat or prevent COVID-19 or may appear to provide easy access to legitimate medicines that are otherwise not readily [...]

2020-03-26T20:24:35+00:0026.03.2020|Pharmacovigilance, Regulatory Affairs|

UK MHRA: Ibuprofen use and Coronavirus (COVID-19)

There is currently no strong evidence that ibuprofen can make coronavirus (COVID-19) worse. Until we have more information, take paracetamol to treat the symptoms of coronavirus, unless your doctor has told you paracetamol is not suitable for you. We are aware there has been concern spreading about the use of ibuprofen and other non-steroidal anti-inflammatory [...]

2020-03-24T18:15:55+00:0024.03.2020|Pharmacovigilance|

Infarmed: Nova edição do Boletim de Farmacovigilância, Volume 24, n.º1, de janeiro de 2020

Já está disponível o Boletim de Farmacovigilância, Volume 24, n.º1, de janeiro de 2020. Pode aceder a esta e a outras edições na área Publicações. Publicação com informação sobre efeitos adversos de medicamentos autorizados, quer a nível nacional quer europeu. Encontra-se também, nesta publicação, informação detalhada sobre os Alertas de Segurança emitidos pelo Infarmed. Posted on the [...]

2020-03-24T18:08:18+00:0024.03.2020|Pharmacovigilance|

Infarmed: Fluorouracilo, capecitabina, tegafur e flucitosina – novas recomendações de segurança

A Agência Europeia do Medicamento (EMA na sigla inglesa) e o Infarmed recomendam que, antes de iniciar o tratamento com medicamentos contendo fluorouracilo, capecitabina e tegafur, seja efetuado o rastreio da deficiência da enzima dihidropirimidina desidrogenase (DPD), através de análise sanguínea ou genética, para evitar o aparecimento de efeitos indesejáveis graves e potencialmente fatais. Os [...]

2020-03-22T20:30:17+00:0022.03.2020|Pharmacovigilance|

WHO Pharmaceuticals Newsletter (No.1, 2020)

The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicines and legal actions taken by regulatory authorities around the world. It also provides signals based on information derived from Individual Case Safety Reports (ICSRs) available in the WHO Global ICSR database, VigiBase®. This edition of the Newsletter includes updates on [...]

Infarmed: EMA confirma informação divulgada pelo Infarmed Ibuprofeno / COVID-19

Ciente das dúvidas que circulam nos órgãos de comunicação social e na opinião pública, a Agência Europeia de Medicamentos (EMA na sigla inglesa) divulgou hoje um comunicado de imprensa onde refere que, presentemente, não existe evidência científica que permita estabelecer uma relação entre a administração de ibuprofeno e o agravamento da infeção por COVID-19. Comunicado de Imprensa [...]

2020-03-21T10:15:42+00:0021.03.2020|Pharmacovigilance|

ANSM: Produits de contraste et risques de réactions d’hypersensibilité immédiate: l’ANSM rappelle les précautions à prendre

L’ANSM est régulièrement informée de la survenue de réactions d’hypersensibilité immédiate (HSI) avec les produits de contraste à visée diagnostique. Ces réactions d’HSI, bien que rares, peuvent engager le pronostic vital et parfois être d’issue fatale. Afin de réduire le risque de réaction d’HSI, l’ANSM rappelle aux professionnels de santé qui réalisent des examens d’imagerie [...]

2020-03-21T10:07:07+00:0021.03.2020|Pharmacovigilance|

EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19

EMA is aware of reports, especially on social media, which raise questions about whether non-steroidal anti-inflammatory medicines (NSAIDs) such as ibuprofen could worsen coronavirus disease (COVID-19). There is currently no scientific evidence establishing a link between ibuprofen and worsening of COVID‑19. EMA is monitoring the situation closely and will review any new information that becomes available [...]

2020-03-20T15:57:59+00:0020.03.2020|Pharmacovigilance|

UK MHRA: Drug Safety Update (March 2020)

Esmya (ulipristal acetate): suspension of the licence due to risk of serious liver injury Contact patients currently taking Esmya for uterine fibroids as soon as possible and advise them to stop their treatment. Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections Caution should be used in patients [...]

2020-03-19T20:58:59+00:0020.03.2020|Pharmacovigilance|

L’ANSM prend des mesures pour favoriser le bon usage du paracétamol – COVID-19

Dans le contexte du COVID-19, l’ANSM rappelle aux patients et aux professionnels de santé qu’en cas de douleur et/ou fièvre, l’utilisation du paracétamol est à privilégier en respectant les règles de bon usage. L’ANSM alerte sur la nécessité de ne pas prescrire, ni délivrer, ni stocker inutilement les médicaments à base de paracétamol. Afin de garantir [...]

2020-03-19T20:53:45+00:0020.03.2020|Pharmacovigilance|

(Cas) AEMPS: Medicamentos antihipertensivos que actúan sobre el sistema renina angiotensina e infección por COVID-19

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. Ante la aparición de algunas publicaciones sugiriendo que el tratamiento con antihipertensivos del tipo IECA y/o ARAII podría ser un factor [...]

2020-03-18T20:47:27+00:0018.03.2020|Pharmacovigilance|

Infarmed: Ausência de evidência entre o agravamento da infeção por COVID-19 e o ibuprofeno

O INFARMED, Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.  informa que não existem, atualmente, dados científicos que confirmem um possível agravamento da infeção por COVID-19 com a administração de ibuprofeno ou outros anti-inflamatórios não esteroides. Neste sentido, não há motivo para os doentes que se encontrem em tratamento com os referidos medicamentos o [...]

2020-03-18T18:18:24+00:0018.03.2020|Pharmacovigilance|