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MHLW Pharmaceuticals and Medical Devices Safety Information (FY2019)

FY 2019 (No.362-)

Japanese version issued on No. Table of contents Posted on PDF
March 24, 2020 371
  1. For the Promotion of Pediatric Clinical Development (development and safety measures) through Active Use of Medical Information Database
    (Part 2) Assessment of Adverse Events with Use of the Pediatric Medical Data Collecting System and Efforts Focused on Future Utilization of the System
  2. Handling of Relative Contraindications associated with Revision of Instructions for Package Inserts of Prescription Drugs
  3. Important Safety Information
    1. Rotigotine
    2. Aminolevulinic acid hydrochloride
  4. Revision of Precautions  (No. 311)
       Rotigotine (and 8 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
Mar 24,
2020
(Full text)
February 18, 2020 370
  1. For the Promotion of Pediatric Clinical Development (development and safety measures) through Active Use of Medical Information Database (Part 1)

    Maintaining the Pediatric Medical Data Collecting System and Examples of a Survey on the Drug Use in Children through Active Use of the System
  2. Post-Marketing Information Collection and Malfunctions Report from Medical Institutions for Medical Devices
  3. Important Safety Information
    1. Ipragliflozin L-Proline
    2. Olmesartan medoxomil
    3. Secukinumab (genetical recombination)
  4. Revision of Precautions (No. 310)
    1. Levodopa
    2. Levodopa/carbidopa hydrate
    3. Levodopa/benserazide hydrochloride (and 6 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
Feb 18,
2020
(Full text)
January 9, 2020 369
  1. Safety of Influenza Antiviral Drugs
  2. Suspected Adverse Reactions to Influenza vaccines in the 2018 Season
  3. Important Safety Information
    1. Atezolizumab (genetical recombination)
    2. Osimertinib mesilate
    3. Bilastine
  4. Revision of Precautions  (No. 309)
    Mecasermin (genetical recombination) (and 3 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
Jan 9,
2020
(Full text)
November 26, 2019 368
  1. Initiative of Revision of the Manuals for Management of Various Serious Adverse Drug Reactions (Part 3)
  2. Important Safety Information
    1. Vonoprazan fumarate
  3. Revision of Precautions  (No. 308)
    Vonoprazan fumarate (and 3 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
Nov 26, 2019 (Full text)
October 23, 2019 367
  1. Publication of Risk Management Plan (RMP) Materials on the PMDA website
  2. Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation with the System
  3. Important Safety Information
    1. Baricitinib
    2. Osimertinib mesilate
  4. Revision of Precautions (No. 307)
    Baricitinib (and 14 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
Oct 23, 2019 (Full text)
September 17, 2019 366
  1. Introduction of the International Standards (ISO [IEC] 80369 series) Related to Connectors for Prevention of Interconnection
    -Switching of small-bore connectors for enteral application
  2. Important Safety Information
    1. Freeze-dried BCG vaccine
  3. Revision of Precautions (No. 306)
    Apomorphine hydrochloride hydrate (and 9 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
Sep 17, 2019 (Full text)
August 6, 2019 365
  1. Review of Contraindications of Metformin including “renal impairment”
    Note) Correction
    English version PDF p.6 “Use in patients with renal impairment” in Table 2. “Major differences in the package inserts in Japan at the time of the Subcommittee on Drug Safety”

    [Original]   Low-dose preparation: Contraindicated to patients with moderate or more severe renal impairment
    High-dose preparation: Contraindicated to patients with mild to severe renal impairment
    [Revised] Low-dose preparation: Contraindicated to patients with mild to severe renal impairment
    High-dose preparation: Contraindicated to patients with moderate or more severe renal impairment
  2. Safety Measures for Febuxostat
  3. Guidance of Appropriate Medication for Elderly Patients  [particular (by recuperation environment)]
  4. Proper Use of Over-the-Counter (OTC) Drugs that May Lead to Abuse
  5. Important Safety Information
    1. Nivolumab (genetical recombination)
    2. Palbociclib
  6. Revision of Precautions (No. 305)
    Epoprostenol sodium (and 10 others)
  7. List of Products Subject to Early Post-marketing Phase Vigilance
Aug 6, 2019 (Full text)
July 2, 2019 364
  1. Interstitial lung disease by abemaciclib
  2. Review of “glaucoma” as a contraindication for anticholinergic drugs
  3. Important Safety Information
    1. Abemaciclib
    2. Nivolumab (genetical recombination)
    3. Baloxavir marboxil
  4. Revision of Precautions (No. 304)
    1. Eletriptan hydrobromide
    2. Zolmitriptan
    3. Naratriptan hydrochloride
    4. Rizatriptan benzoate (and 6 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
July 2, 2019 (Full text)
June 4, 2019 363
  1. Direct Patient Reporting System for Adverse Drug Reactions
  2. Research Project on Development of Educational Programs for Healthcare Professionals who Engage in Interviews with Patients about Sensitive Matters
  3. Important Safety Information
    1. Dulaglutide (genetical recombination)
    2. Empagliflozin
    3. Nivolumab (genetical recombination)
    4. Lenvatinib mesilate
    5. Influenza HA vaccine
  4. Revision of Precautions (No. 303)
    Dulaglutide (genetical recombination) (and 11 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
June 4, 2019 (Full text)
April 16, 2019 362
  1. Guidelines for Prescription Drug Marketing Information Provision
  2. Revision of Package Inserts of Intravenous Injection Products Containing Sorbitol or Fructose as Excipient for Use in Patients with Hereditary Fructose Intolerance
  3. Important Safety Information
    1. Baloxavir marboxil
    2. Quetiapine fumarate
    3. (1) Vonoprazan fumarate
      (2) Vonoprazan fumarate/amoxicillin hydrate/clarithromycin
      (3) Vonoprazan fumarate/amoxicillin hydrate/metronidazole
  4. Revision of Precautions (No. 302)

    Oseltamivir phosphate (and 7 others)

  5. List of Products Subject to Early Post-marketing Phase Vigilance
Apr 16, 2019 (Full text)

 

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