MHLW Pharmaceuticals and Medical Devices Safety Information (FY2024)

Full text [1,009 KB]

• Article 1. Utilization of Risk Management Plan (RMP) in Clinical Settings
• Article 2. Revisions of PRECAUTIONS for Carvedilol and Bisoprolol
• Article 3. Important Safety Information

Article 3.-1 Andexanet alfa (genetical recombination)

• Article 4. Revisions of PRECAUTIONS (No.349)

Article 4.-1 Andexanet alfa (genetical recombination) (and 4 others)

• Article 5. List of Products Subject to Early Post-marketing Phase Vigilance

• (Reference) Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)