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Post-marketing Safety Measures

MHLW Pharmaceuticals and Medical Devices Safety Information (FY2024)

FY 2024 (No.409-)

Issue No. Table of contents
June 2024 410

Full text [241 KB]

  • Article 1. Drug-induced Enterocolitis Syndrome
  • Article 2. Revisions of PRECAUTIONS (No. 350)

Article 2.-1 Rivaroxaban (and 4 others)

  • Article 3. List of Products Subject to Early Post-marketing Phase Vigilance
April 2024 409

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)