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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
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
 October 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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