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MHLW Pharmaceuticals and Medical Devices Safety Information (FY2021)

FY 2021 (No.382-)

Japanese version issued on No. Table of contents Posted on PDF
March 8,
2022
390
  1. Revision of Precautions for Aminolevulinic Acid Hydrochloride
  2. Revision of Precautions  (No. 330)
    Aminolevulinic acid hydrochloride (and 1 other)
  3. List of Products Subject to Early Post-marketing Phase Vigilance
Mar 8, 2022 (Full text)
January 18,
2022
389
  1. How to Start and Proceed with Improving Polypharmacy among the Elderly in Hospitals
  2. Important Safety Information
    1. Fingolimod hydrochloride
  3. Revision of Precautions  (No. 329)
    Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection) (and 11 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
Jan 18, 2022 (Full text)
December 14,
2021
388
  1. Suspected Adverse Reactions to Influenza Vaccines in the 2020 Season
  2. Important Safety Information
    1. Atezolizumab (genetical recombination)
  3. Revision of Precautions (No. 328)
    Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection) (and 2 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
Dec 14,
2021
(Full text)
November 9,
2021
387
  1. Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation with the System
  2. Acute coronary syndrome accompanying allergic reaction (Kounis Syndrome)
  3. Important Safety Information
    1. Cefoperazone sodium/sulbactam sodium
  4. Revision of Precautions  (No. 327)
    Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection) (and 5 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
Nov 9,
2021
(Full text)
October 5,
2021
386
  1. Precautions for Shock, Anaphylaxis in Patients Who Received Joyclu 30mg intra-articular injection to Improve Joint Function
  2. Revision of Precautions  (No. 326)
    COVID-19 (SARS-CoV-2) vaccine (recombinant chimpanzee adenovirus vector) (and 2 others)
  3. List of Products Subject to Early Post-marketing Phase Vigilance
Oct 5,
2021
(Full text)
August 20,
2021
385
  1. Revision of Proper Control Procedures for Revlimid/Pomalyst (RevMate)
  2. Important Safety Information
    1. [1] Magnesium sulfate hydrate/glucose [2] Magnesium sulfate hydrate
  3. Revision of Precautions (No. 325)
    Nivolumab (genetical recombination) (and 9 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
Aug 20, 2021 (Full text)
July 13, 2021 384
  1. Blood Monitoring and Rechallenge with Clozapine
  2. Important Safety Information
    1. Pembrolizumab (genetical recombination)
    2. Ixekizumab (genetical recombination)
  3. Revision of Precautions  (No. 324)
    Diclofenac etalhyaluronate sodium (and 3 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
Jul 13,
2021
(Full text)
June 10, 2021 383
  1. MID-NET (Medical Information Database NETwork)
  2. Revision of Precautions  (No. 323)
    Shosaikotokakikyosekko
  3. List of Products Subject to Early Post-marketing Phase Vigilance
Jun 10, 2021 (Full text)
April 27, 2021 382
  1. PI (Package insert)-navi: A Smartphone App Designed for Digitized Package Inserts
  2. Digitization of Reports from Medical Institutions on Adverse Drug Reactions and Post-vaccination Suspected Adverse Reactions
  3. Important Safety Information
    1. Ritodrine hydrochloride (injections)
    2. Durvalumab (genetical recombination)
    3. Onasemnogene abeparvovec
  4. Revision of Precautions  (No. 322)
    Magnesium sulfate hydrate/glucose (preparations indicated for prophylaxis and treatment of eclampsia in severe hypertensive disorders of pregnancy)
    (and 8 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
Apr 27, 2021 (Full text)

 

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