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MHLW Pharmaceuticals and Medical Devices Safety Information (FY2022)

FY 2022 (No.391-)

Japanese version issued on No. Table of contents Posted on PDF
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 1 other)
  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)

 

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