MHLW Pharmaceuticals and Medical Devices Safety Information (FY2024)

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• Article 1. Revisions of PRECAUTIONS for Preparations Containing Brimonidine Tartrate
• Article 2. Recent Efforts on MID-NET
• Article 3. Important Safety Information

Article 3.-1
[1] Brimonidine tartrate
[2] Brimonidine tartrate/timolol maleate
[3] Brimonidine tartrate/brinzolamide
[4] Ripasudil hydrochloride hydrate/brimonidine tartrate

• Article 4. Revisions of PRECAUTIONS (No.351)

Article 4.-1 Pembrolizumab (genetical recombination) (and 6 others)

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

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• 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

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• 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)