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Direct Healthcare Professional Communication (DHPC) - Finasteride, dutasteride – New measures to minimise the risk of suicidal ideation Highlights News

Finasteride, dutasteride – New measures to minimise the risk of suicidal ideation.

Tue Sep 16 00:00:00 CEST 2025 Safety of medicinal products

Direct Healthcare Professional Communication (DHPC) - Clozapine and risk of neutropenia and agranulocytosis: PRAC updates recommendations for blood count monitoring Highlights News

The PRAC has updated recommendations for blood monitoring in patients treated with clozapine. This medicine, indicated for treatment-resistant schizophrenia and psychotic disorders in Parkinson's disease, may increase the risk of neutropenia (reduction in neutrophils) and agranulocytosis.

Mon Sep 08 00:00:00 CEST 2025 Safety of medicinal products

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 September 2025 Highlights News

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 September 2025.

Fri Sep 05 00:00:00 CEST 2025 Safety of medicinal products

Direct communication with healthcare professionals on risperidone-containing medicines Highlights News

Risperidone-containing medicines 1 mg/mL in oral solution formulation: medication error associated with accidental overdose in children and adolescents.

Wed Jul 16 00:00:00 CEST 2025 Safety of medicinal products

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 July 2025 Highlights News

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 July 2025.

Fri Jul 11 00:00:00 CEST 2025 Safety of medicinal products

Important update from the PRAC about Ozempic, Rybelsus and Wegovy (semaglutide) Highlights News

NAION (non-arteritic anterior ischemic optic neuropathy), a serious ocular condition that may cause loss of vision or rapidly worsening eyesight, is a very rare side effect of these medicines.

Fri Jun 06 00:00:00 CEST 2025 Safety of medicinal products

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 june 2025 Highlights News

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 june 2025.

Fri Jun 06 00:00:00 CEST 2025 Safety of medicinal products

Direct communication with healthcare professionals on Mysimba (naltrexone/bupropione) Highlights News

AIFA, in agreement with the European Medicines Agency and the Marketing Authorisation Holder, informs the Healthcare Professionals on the new recommendations for use of the medicinal product Mysimba, indicated for the management of weight adult patients with obesity or in the presence of weight-related comorbidities.

Thu May 29 00:00:00 CEST 2025 Safety of medicinal products

Direct communication with healthcare professionals on Kisqali (ribociclib) Highlights News

The Italian Medicines Agency (AIFA), in collaboration with the European Medicines Agency (EMA), communicates a change in the storage conditions and the validity period of the medicine Kisqali (ribociclib).

Mon May 12 00:00:00 CEST 2025 Safety of medicinal products

EMA starts review of Ixchiq (live attenuated chikungunya vaccine)

MA’s safety committee (PRAC) has started a review of Ixchiq (a live attenuated chikungunya vaccine) following reports of serious adverse events in elderly people. 

Thu May 08 00:00:00 CEST 2025 Safety of medicinal products

Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines Highlights News

Following an EU-wide review of available data on finasteride and dutasteride medicines, EMA’s safety committee, PRAC, has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1 and 5 mg tablets.

Thu May 08 00:00:00 CEST 2025 Safety of medicinal products

Communication on the national management of Follow-UP questionnaires Highlights News

Following the publication by the European Medicines Agency (EMA) of the ‘Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)’, effective from 1 February 2025, the Italian Medicines Agency (AIFA) would like to provide clarification on the nature and management of the Specific AR FUQs.

Wed Apr 02 00:00:00 CEST 2025 Safety of medicinal products

EMA concludes review of weight management medicine Mysimba Highlights News

EMA’s human medicines committee (CHMP) has finalised its review of Mysimba (naltrexone / bupropion), a medicine used for weight management in adults, concerning the potential long-term cardiovascular risk.

Fri Mar 28 00:00:00 CET 2025 Safety of medicinal products

Unregulated advanced therapy medicinal products pose serious risks to health Highlights News

EMA and the Heads of Medicines Agencies (HMA) are warning the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) offered to patients in the European Union.

Thu Mar 13 00:00:00 CET 2025 Safety of medicinal products

Meeting highlights from the PRAC 13-16 January 2025 Highlights News

Meeting highlights from the PRAC 13-16 January 2025.

Fri Jan 17 00:00:00 CET 2025 Safety of medicinal products

Chiarimenti sulla gestione delle segnalazioni di sospetta reazione avversa (ADR) da Radiofarmaci Highlights News

L'Agenzia Italiana del Farmaco (AIFA) pubblica il documento che fornisce chiarimenti sulla gestione, dal punto di vista regolatorio, delle segnalazioni di sospette reazioni avverse conseguenti l’utilizzo di Radiofarmaci, in funzione delle diverse situazioni di uso e/o autorizzazione di tali medicinali. 

Tue Jan 14 00:00:00 CET 2025 Safety of medicinal products

Direct communication with healthcare professionals on Veoza (fezolinetant) Highlights News

Veoza (fezolinetant): risk of drug-induced liver injury and new recommendations on monitoring of liver function before and during treatment.

Mon Jan 13 00:00:00 CET 2025 Safety of medicinal products

Direct communication with healthcare professionals on Alofisel (darvadstrocel) Highlights News

Alofisel (darvadstrocel): Withdrawal from the EU market as its clinical benefit is no longer demonstrated to justify its continued use.

Thu Dec 19 00:00:00 CET 2024 Safety of medicinal products

Direct communication with healthcare professionals on Metamizole-containing medicines Highlights News

Metamizole-containing medicines: important measures to minimise the serious outcomes of known risk of agranulocytosis.

Mon Dec 09 00:00:00 CET 2024 Safety of medicinal products

Meeting highlights from the PRAC 25-28 November 2024 Highlights News

Meeting highlights from the PRAC 25-28 November 2024.

Fri Nov 29 00:00:00 CET 2024 Safety of medicinal products

Updated advice to minimise risks of interaction between weight loss medicine Mysimba and opioids Highlights News

After re-examining its initial opinion, EMA recommends updating the advice aimed at minimising the risks of interaction between the weight loss medicine Mysimba (naltrexone/bupropion) and opioid-containing medicines.

Fri Nov 15 00:00:00 CET 2024 Safety of medicinal products

Direct communication with healthcare professionals on Thiocolchicoside-containing medicines for systemic use Highlights News

The contraindications of use for thiocolchicoside-containing medicines for systemic use have been updated, and the contraceptive measures for female and male patients have been extended.

Mon Oct 28 00:00:00 CET 2024 Safety of medicinal products

Direct communication with healthcare professionals on medicines containing 5-fluorouracil Highlights News

Medicines containing 5-fluorouracil (i.v.): In patients with moderate or severe renal impairment, phenotyping for dihydropyrimidine dehydrogenase (DPD) deficiency by measuring blood uracil levels should be interpreted with caution

Thu Oct 24 00:00:00 CEST 2024 Safety of medicinal products

Direct communication with healthcare professionals on Medrossiprogesterone acetato Highlights News

Medroxyprogesterone acetate: Risk of meningioma and measures to minimise this risk.

Thu Oct 10 00:00:00 CEST 2024 Safety of medicinal products

Direct communication with healthcare professionals on Oxbryta (voxelotor) Highlights News

Oxbryta (voxelotor): Suspension of EU marketing authorisation.

Mon Oct 07 00:00:00 CEST 2024 Safety of medicinal products

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