MHLW Pharmaceuticals and Medical Devices Safety Information (FY2020)

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**FY 2020 (No.372-)**
Japanese version issued on	No.	Table of contents	PDF
March 23, 2021	381	Digitization of Package Inserts Safety in Co-administration of Sildenafil (indicated for pulmonary arterial hypertension) and Amiodarone (oral dosage form) Important Safety Information Salbutamol sulfate Revision of Precautions (No. 321) Aspirin (preparations indicated for antipyresis, analgesia, anti-inflammation, prevention of thrombus/embolus formation, Kawasaki disease) (and 22 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [935 KB]
February 24, 2021	380	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 Important Safety Information Pomalidomide Revision of Precautions (No. 320) Alemtuzumab (genetical recombination) (1 other) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [265 KB]
January 7, 2021	379	Revision of PMDA Medical Safety Information for Ensuring Use of Insulin Syringes Revision of Precautions (No. 319) Clopidogrel sulfate (and 4 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [583 KB]
December 1, 2020	378	Utilization of Risk Management Plan (RMP) of Drugs and Request for Participation in a Survey Investigating Utilization of Safety Information through PMDA Medi-navi Important Safety Information Nivolumab (genetical recombination) Revision of Precautions (No. 318) Glatiramer acetate (1 other) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [311 KB]
November 4, 2020	377	Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation with the System Revision of Dosing Intervals between Different Vaccines Important Safety Information Vonoprazan fumarate Revision of Precautions (No. 317) Vonoprazan fumarate (and 3 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [531 KB]
October 6, 2020	376	Suspected Adverse Reactions to Influenza vaccines in the 2019 Season Important Safety Information Relugolix Revision of Precautions (No. 316) Relugolix and 1 other List of Products Subject to Early Post-marketing Phase Vigilance	Full text [187 KB]
August 21, 2020	375	Revisions of Precautions in Package Inserts concerning the Dosing Intervals between Different Vaccines Review of Contraindications including “patients with serious renal disorder” of Parenteral Nutrition Preparations and Amino Acid Preparations for Renal Failure Important Safety Information Iopamidol Revision of Precautions (No. 315) Iodixanol Iohexol (preparations with indications of cerebral angiography) (and 5 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [203 KB]
July 14, 2020	374	Revision of Package Inserts regarding Insulin Vial Preparations Initiatives to Ensure Safety of Homecare Medical Devices against Radio Waves Emitted by Mobile Phones, etc. Important Safety Information Memantine hydrochloride Bevacizumab (genetical recombination) including the biosimilars Revision of Precautions (No. 314) Memantine hydrochloride and 1 other List of Products Subject to Early Post-marketing Phase Vigilance	Full text [2.1 MB]
June 16, 2020	373	Recent Trends in Cybersecurity Assurance of Medical Devices Important Safety Information Apalutamide Revision of Precautions (No. 313) Insulin human (genetical recombination) (vial preparations) Insulin aspart (genetical recombination) (vial preparations without description for continuous subcutaneous insulin infusion (CSII) therapy in the Dosage and Administration section) Insulin glargine (genetical recombination) (vial preparations) (and 7 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [327 KB]
April 28, 2020	372	Genome Research on Drug-related Severe Cutaneous Adverse Reactions Important Safety Information Pembrolizumab (genetical recombination) Revision of Precautions (No. 312) Spiperone Timiperone Pipamperone hydrochloride (and 12 others) List of Products Subject to Early Post-marketing Phase Vigilance	Full text [552 KB]