Saturday, February 8, 2025

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AIFA

Important Notice for Healthcare Professionals Regarding Infanrix Hexa Needle Soft Packs

Key TakeawaysA packaging issue affecting the sterility of needle soft packs included with Infanrix Hexa pediatric vaccines has been identified. The defect involves...

EMA Launches Safety Review of Finasteride and Dutasteride for Links to Suicidal Ideation

Key TakeawaysThe European Medicines Agency (EMA) has initiated a safety review of medicines containing finasteride and dutasteride due to concerns over potential links...

New 5% Pay-Back Platform Launch for 2024: Pharmaceutical Companies to Start Procedure on October 11 in Italy

Key TakeawaysThe 5% pay-back program allows pharmaceutical companies to suspend a 5% price reduction by making payments to regional authorities, with a deadline...

Medroxyprogesterone Acetate: FDA Issues Advisory on Meningioma Risk and New Safety Guidelines

Key TakeawaysHigh doses of medroxyprogesterone acetate, especially after prolonged use, increase the risk of meningioma. For non-oncological uses, medroxyprogesterone is now contraindicated in...

AIFA Updates Managed Entry Agreement Procedures to Enhance Patient Access and Data Quality

The Italian Medicines Agency (AIFA) has announced an update to the procedure for tracking reimbursements under Managed Entry Agreements (MEAs). This initiative is aimed...

Pricing and Evaluation Reforms Mark the Launch of Italy’s New Scientific-Economic Pharmaceutical Commission

The Italian Medicines Agency (AIFA) has officially announced the establishment of its new Scientific-Economic Pharmaceutical Commission (CSE), a pivotal move designed to enhance the...

Italian Medicines Agency Undergoes Major Organizational Restructuring

The Italian Ministry of Health has enacted significant reforms in the structure of the Italian Medicines Agency (AIFA) through Decree 3/2024, published in the...

Exploring the Impact of AIFA Reforms on Market Access in Italy

A webinar is being organized by Global Whispers on 12th October at 1.00 pm (BST)/2.00 pm (CEST)/8.00 am (EDT). The session will be led...

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