MHLW Pharmaceuticals and Medical Devices Safety Information (FY2024)

• Article 1. Revisions of Precautions for pembrolizumab (genetical recombination) (pancreatic exocrine insufficiency)
• Article 2. Important Safety Information
• Article 2.-1 Injectable preparations containing arginine
• Article 3. Revisions of PRECAUTIONS (No.357)
  Article 3.-1
  [1] Twinpal Injection
  [2] Plas-Amino Injection
  [3] Argi-U Injection 20 g (and 4 others)
• Article 4. List of Products Subject to Early Post-marketing Phase Vigilance

• Article 1. Revision of PRECAUTIONS for Oral Antivirals Against COVID-19 (Xocova Tablets 125 mg and Lagevrio Capsules 200 mg)
• Article 2. Important Safety Information
  Article 2.-1
  [1] Ipragliflozin L-proline
  [2] Sitagliptin phosphate hydrate/ipragliflozin L-proline
  [3] Empagliflozin
  [4] Empagliflozin/linagliptin
  [5] Canagliflozin hydrate
  [6] Teneligliptin hydrobromide hydrate/canagliflozin hydrate
  [7] Dapagliflozin propylene glycolate hydrate
  [8] Tofogliflozin hydrate
  [9] Luseogliflozin hydrate
  Article 2.-2 Sorafenib tosilate
  Article 2.-3 Vedolizumab (genetical recombination)
  Article 2.-4 Gemcitabine hydrochloride
• Article 3. Revisions of PRECAUTIONS (No.356)
  Article 3.-1 Esaxerenone (and 17 others)
• Article 4. List of Products Subject to Early Post-marketing Phase Vigilance

• Article 1. Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation With the System
• Article 2. Important Safety Information
  Article 2.-1 Triamcinolone acetonide (ophthalmic injection)
• Article 3. Revisions of PRECAUTIONS (No.355)
  Article 3.-1 Lithium carbonate (and 8 others)
• Article 4. List of Products Subject to Early Post-marketing Phase Vigilance

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• Article 1. Suspected Adverse Reactions to Influenza Vaccines in the 2023 Season
• Article 2. Revision of PRECAUTIONS for Non-steroidal Anti-inflammatory Drugs Regarding Myocardial Infarction and Cerebrovascular Disorder
• Article 3. Revisions of PRECAUTIONS (No. 354)
  Article 3.-1 Aspirin (preparations indicated for antipyresis/analgesia/anti-inflammation) (and 17 others)
• Article 4. List of Products Subject to Early Post-marketing Phase Vigilance

Full text [406 KB]

• Article 1. Revision of PRECAUTIONS for Sodium Valproate
• Article 2. Revision of Precautions for Mirogabalin Besilate
• Article 3. Important Safety Information
  Article 3.-1 Mirogabalin besilate
  Article 3.-2 Pemafibrate
  Article 3.-3 Purified pineapple stem juice
  Article 3.-4 [1]Preparations containing sulfamethoxazole sodium, [2]Preparations containing sulfamethoxazole
• Article 4. Revisions of PRECAUTIONS (No.353)
  Article 4.-1 Sodium valproate (and 9 others)
• Article 5. List of Products Subject to Early Post-marketing Phase Vigilance

Full text [356 KB]

• Article 1. How to Start and Proceed With Improving Polypharmacy Among the Elderly in Regions
• Article 2. Important Safety Information
  Article 2.-1 Epoprostenol sodium
  Article 2.-2 [1] Nivolumab (genetical recombination), [2] Ipilimumab (genetical recombination)
  Article 2.-3 Tirabrutinib hydrochloride
  Article 2.-4 Gadobutrol
• Article 3. Revisions of PRECAUTIONS (No.352)
  Article 3.-1 Freeze-dried smallpox vaccine prepared in cell culture (and 7 others)
• Article 4. List of Products Subject to Early Post-marketing Phase Vigilance

Full text [389 KB]

• 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

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

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)