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Post-marketing Safety Measures

MHLW Pharmaceuticals and Medical Devices Safety Information (FY2022)

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FY 2022 (No.391-399)

Japanese version issued on No. Table of contents Posted on PDF
March 14,
2023		 399
  1. Safety Control Measures for Generic Lenalidomide Preparations
  2. Important Safety Information
    1. Preparations containing GLP-1 receptor agonists and tirzepatide
      [1] Liraglutide (genetical recombination), [2] Exenatide, [3] Lixisenatide, [4] Dulaglutide (genetical recombination), [5] Semaglutide (genetical recombination), [6] Insulin degludec (genetical　recombination)/liraglutide (genetical recombination), [7] Insulin glargine (genetical recombination)/lixisenatide, [8] Tirzepatide
    2. Tazobactam/piperacillin hydrate
  3. Revision of Precautions (No. 339)
    Exenatide, semaglutide (genetical recombination), dulaglutide (genetical recombination), lixisenatide, liraglutide (genetical recombination), insulin glargine (genetical recombination)/lixisenatide, insulin degludec (genetical recombination)/liraglutide (genetical recombination) (and 2 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
 Mar 14, 2023 (Full text)
February 14,
2023		 398
  1. Revisions of Precautions for 2 Calcium Channel Blockers (Amlodipine Besilate and Nifedipine)
  2. Revision of Precautions for Hydroxyethylated Starch
  3. Revision of the Package Insert for Hypothyroidism and Request for Adverse Drug Reaction Reports, etc.
  4. Important Safety Information
    1. Preparations containing acetaminophen
    2. Preparations containing clopidogrel sulfate
    3. Oral live attenuated human rotavirus vaccine
  5. Revision of Precautions (No. 338)
    Amlodipine besilate (and 16 others)
  6. List of Products Subject to Early Post-marketing Phase Vigilance
 Feb 14, 2023 (Full text)
December 14,
2022		 397
  1. Suspected Adverse Reactions to Influenza Vaccines in the 2021 Season
  2. Important Safety Information
    1. Roxadustat
    2. Preparations containing hydrochlorothiazide
    3. Imatinib mesilate
  3. Revision of Precautions  (No. 337)
    Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
     (Comirnaty RTU intramuscular injection (Bivalent: Original/Omicron BA.1), Comirnaty RTU intramuscular injection (Bivalent: Original/Omicron BA.4-5),
    Spikevax Intramuscular Injection (Bivalent: Original/Omicron BA.1)) (and 12 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
 Dec 14, 2022 (Full text)
November 9,
2022		 396
  1. Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation with the System
  2. Revisions of Precautions for Pemafibrate
  3. Important Safety Information
    1. Methotrexate
  4. Revision of Precautions (No. 336)
    Loxoprofen sodium hydrate (oral dosage form) (and 9 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
 Nov 11, 2022 (Full text)
September 27,
2022		 395
  1. Revision of Precautions regarding the Co-administration of Riociguat with HIV Protease Inhibitors
  2. Important Safety Information
    1. Ramucirumab (genetical recombination)
  3. Revision of Precautions  (No. 335)
    Hydroxychloroquine Sulfate (and 5 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
 Sep 27, 2022 (Full text)
August 23,
2022		 394
  1. Genome Research on Drug-induced Interstitial Lung Disease
  2. Revision of Precautions for Zolpidem Tartrate, Zopiclone, Eszopiclone, Triazolam
  3. Important Safety Information
    1. Durvalumab (genetical recombination)
    2. Avelumab (genetical recombination)
  4. Revision of Precautions  (No. 334)
    Recombinant COVID-19 (SARS-CoV-2) vaccine (Nuvaxovid Intramuscular Injection) (and 9 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
 Aug 23,
2022		 (Full text)
July 12,
2022		 393
  1. The Manuals for Management of Various Serious Adverse Drug Reactions
  2. Important Safety Information
    1. Cetuximab sarotalocan sodium (genetical recombination)
    2. Nirmatrelvir/ritonavir
    3. Molnupiravir
  3. Revision of Precautions  (No. 333)
    Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
     (Comirnaty intramuscular injection, Comirnaty intramuscular injection for 5 to 11 years old, Spikevax Intramuscular Injection) (and 7 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
 Jul 12,
2022		 (Full text)
June 10,
2022		 392
  1. Revision of Precautions for Somatropin (genetical recombination)
  2. Revisions of Precautions for Interferon Beta-1a (genetical recombination) and Interferon Beta-1b (genetical recombination)
  3. New Project Development of the “Japan Drug Information Institute in Pregnancy”
  4. Important Safety Information
    1. [1] Dexamethasone (oral dosage form) (preparations indicated for pituitary suppression tests) (and 9 others)
  5. Revision of Precautions  (No. 332)
    Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection) (and 15 others)
  6. List of Products Subject to Early Post-marketing Phase Vigilance
 Jun 10, 2022 (Full text)
April 12,
2022		 391
  1. Revision of Precautions of Levonorgestrel (indicated for emergency contraception)
  2. Digitization of Reports from Medical Professionals on Adverse Reactions/Infections/Malfunctions and Suspected Adverse Reactions [Information on the Report Reception Site]
  3. Important Safety Information
    1. Nintedanib ethanesulfonate
  4. Revision of Precautions (No. 331)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
 Apr 12, 2022 (Full text)