FY 2018 (No.352-)
Japanese version issued on |
No. |
Table of contents |
PDF |
March 12,
2019 |
361 |
- Genome Research relating to Drug-induced Muscle Disorders
- Important Safety Information
- Trastuzumab (genetical recombination) and other follow-on biologics
- Nivolumab (genetical recombination)
- Palbociclib
- Pembrolizumab (genetical recombination)
- Revision of Precautions (No. 301)
Eliglustat tartrate (and 5 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [356 KB] |
February 5,
2019 |
360 |
- Package Inserts of Prescription Drugs under the Revised Instructions
- Important Safety Information
- Nusinersen sodium
- Axitinib
- Revision of Precautions (No. 300)
Nusinersen sodium (and 5 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [248 KB] |
December 25,
2018 |
359 |
- Safety of Influenza Antiviral Drugs
- Suspected Adverse Reactions to Influenza vaccines in the 2017 Season
- Important Safety Information
- (1) Aluminum potassium sulfate hydrate/tannic acid (with saline)
(2) Aluminum potassium sulfate hydrate/tannic acid (with analgesic agents)
- Calcitriol (injectable dosage form)
- Freeze-dried live attenuated varicella vaccine
- Revision of Precautions (No. 299)
Aluminum potassium sulfate hydrate/tannic acid (with saline)(and 3 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [208 KB] |
Novmber 20,
2018 |
358 |
- Safety Measures for Influenza Antiviral Drugs
- Results of a Survey Investigating Access, Communication, and Utilization of Drug Safety Information at Hospitals and Pharmacies and Desirable Directions
- Important Safety Information
- Secukinumab (genetical recombination)
- Lamotrigine
- Lenvatinib mesilate
- Revision of Precautions (No. 298)
(1) Atorvastatin calcium hydrate
(2) Ezetimibe/atorvastatin calcium hydrate
(3) Pravastatin sodium
(4) Amlodipine basilate/atorvastatin calcium hydrate (and 11 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [482 KB] |
October 16,
2018 |
357 |
- Initiative of Revision of the Manuals for Management of Various Serious Adverse Drug Reactions (Part 2)
- Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation with the System
- Revision of Precautions (No. 297)
Amantadine hydrochloride (and 13 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [771 KB] |
September 4,
2018 |
356 |
- Guidance on Safe and Secure Radio Wave Utilization in Medical Institutions
- Important Safety Information
- Ceftriaxone sodium hydrate
- Revision of Precautions (No. 296)
(1) Apremilast (and 1 other)
- List of Products Subject to
Early Post-marketing Phase Vigilance
|
Full text [844 KB] |
August 7,
2018 |
355 |
- Review of Contraindications for Immunosuppressants in Pregnant Women, etc.
- List of Products Subject to Early Post-marketing Phase Vigilance
(Reference)
Revision of the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance)
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Full text [624 KB] |
July 3,
2018 |
354 |
- Guidance of Appropriate Medication for Elderly Patients (general)
- Important Safety Information
- Pegfilgrastim (genetical recombination)
- Filgrastim (genetical recombination, follow on biologics)
- Lenograstim (genetical recombination)
- Revision of Precautions (No. 295)
(1) Amiodarone hydrochloride
(and 4 others)
- List of Products Subject to
Early Post-marketing Phase Vigilance
|
Full text [755 KB] |
May 22,
2018 |
353 |
- Initiative for the Compilation of Database-stored Data and Provision of Information concerning Pediatric Drugs
- Important Safety Information
- Pembrolizumab (genetical recombination)
- Revision of Precautions (No. 294)
(1) Omarigliptin
(2) Saxagliptin hydrate
(3) Trelagliptin succinate (and 3 others)
- List of Products Subject to
Early Post-marketing Phase Vigilance
|
Full text [504 KB] |
April 17,
2018 |
352 |
- Introduction of the International Standards (ISO [IEC] 80369 series) Related to Connectors for Prevention of Interconnection
- Switching of small-bore connectors for neuraxial anesthesia -
- Important Safety Information
(1) Tolvaptan
(2) Anagliptin, linagliptin, teneligliptin hydrobromide hydrate, teneligliptin hydrobromide hydrate/canagliflozin hydrate
(3) Anagliptin
(4) Sterile talc
- Revision of Precautions (No. 293)
Tolvaptan (and 5 others)
- List of Products Subject to
Early Post-marketing Phase Vigilance
|
Full text [386 KB] |