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Post-marketing Safety Measures

MHLW Pharmaceuticals and Medical Devices Safety Information (FY2020)

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FY 2020 (No.372-)
Japanese version issued on No. Table of contents Posted on PDF
March 23, 2021 381
  1. Digitization of Package Inserts
  2. Safety in Co-administration of Sildenafil (indicated for pulmonary arterial hypertension) and Amiodarone (oral dosage form)
  3. Important Safety Information
    1. Salbutamol sulfate
  4. Revision of Precautions (No. 321)
    Aspirin (preparations indicated for antipyresis, analgesia, anti-inflammation, prevention of thrombus/embolus formation, Kawasaki disease) (and 22 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
 Mar 23,
2021		 (Full text)
February 24, 2021 380
  1. Revision of Precautions for Lidocaine Hydrochloride/Adrenaline Injections concerning Patients for Whom Anaesthesia Is Intended for Ears or Digits as Contraindication in Conduction or Infiltration Anaesthesia
  2. Important Safety Information
    1. Pomalidomide
  3. Revision of Precautions (No. 320)
    Alemtuzumab (genetical recombination) (1 other)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
 Feb 24,
2021		 (Full text)
January 7, 2021 379
  1. Revision of PMDA Medical Safety Information for Ensuring Use of Insulin Syringes
  2. Revision of Precautions (No. 319)
    Clopidogrel sulfate (and 4 others)
  3. List of Products Subject to Early Post-marketing Phase Vigilance
 Jan 7,
2021		 (Full text)
December 1, 2020 378
  1. Utilization of Risk Management Plan (RMP) of Drugs and Request for Participation in a Survey Investigating Utilization of Safety Information through PMDA Medi-navi
  2. Important Safety Information
    1. Nivolumab (genetical recombination)
  3. Revision of Precautions (No. 318)
    Glatiramer acetate (1 other)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
 Dec 1,
2020		 (Full text)
November 4, 2020 377
  1. Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation with the System
  2. Revision of Dosing Intervals between Different Vaccines
  3. Important Safety Information
    1. Vonoprazan fumarate
  4. Revision of Precautions (No. 317)
    Vonoprazan fumarate (and 3 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
 Nov 4, 2020 (Full text)
October 6, 2020 376
  1. Suspected Adverse Reactions to Influenza vaccines in the 2019 Season
  2. Important Safety Information
    1. Relugolix
  3. Revision of Precautions (No. 316)
    Relugolix and 1 other
  4. List of Products Subject to Early Post-marketing Phase Vigilance
 Oct 6, 2020 (Full text)
August 21, 2020 375
  1. Revisions of Precautions in Package Inserts concerning the Dosing Intervals between Different Vaccines
  2. Review of Contraindications including “patients with serious renal disorder” of Parenteral Nutrition Preparations and Amino Acid Preparations for Renal Failure
  3. Important Safety Information
    1. Iopamidol
  4. Revision of Precautions (No. 315)
    1. Iodixanol
    2. Iohexol (preparations with indications of cerebral angiography) (and 5 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
 Aug 21, 2020 (Full text)
July 14, 2020 374
  1. Revision of Package Inserts regarding Insulin Vial Preparations
  2. Initiatives to Ensure Safety of Homecare Medical Devices against Radio Waves Emitted by Mobile Phones, etc.
  3. Important Safety Information
    1. Memantine hydrochloride
    2. Bevacizumab (genetical recombination) including the biosimilars
  4. Revision of Precautions (No. 314)
    Memantine hydrochloride and 1 other
  5. List of Products Subject to Early Post-marketing Phase Vigilance
 Jul 14,
2020		 (Full text)
June 16, 2020 373
  1. Recent Trends in Cybersecurity Assurance of Medical Devices
  2. Important Safety Information
    1. Apalutamide
  3. Revision of Precautions (No. 313)
    1. Insulin human (genetical recombination) (vial preparations)
    2. Insulin aspart (genetical recombination) (vial preparations without description for continuous subcutaneous insulin infusion (CSII) therapy in the Dosage and Administration section)
    3. Insulin glargine (genetical recombination) (vial preparations)
      (and 7 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
 Jun 16, 2020 (Full text)
April 28, 2020 372
  1. Genome Research on Drug-related Severe Cutaneous Adverse Reactions
  2. Important Safety Information
    1. Pembrolizumab (genetical recombination)
  3. Revision of Precautions (No. 312)
    1. Spiperone
    2. Timiperone
    3. Pipamperone hydrochloride (and 12 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
 Apr 28, 2020 (Full text)