MHLW Pharmaceuticals and Medical Devices Safety Information (FY2018)

1. Initiative of Revision of the Manuals for Management of Various Serious Adverse Drug Reactions (Part 2)
2. Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation with the System
3. Revision of Precautions (No. 297)
   Amantadine hydrochloride (and 13 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance

1. Guidance on Safe and Secure Radio Wave Utilization in Medical Institutions
2. Important Safety Information

1. Ceftriaxone sodium hydrate

3. Revision of Precautions (No. 296)

(1) Apremilast (and 1 other)

4. List of Products Subject to
   Early Post-marketing Phase Vigilance

1. Review of Contraindications for Immunosuppressants in Pregnant Women, etc.
2. List of Products Subject to Early Post-marketing Phase Vigilance

Revision of the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance)

1. Guidance of Appropriate Medication for Elderly Patients (general)
2. Important Safety Information

1. Pegfilgrastim (genetical recombination)
2. Filgrastim (genetical recombination, follow on biologics)
3. Lenograstim (genetical recombination)

3. Revision of Precautions (No. 295)
   (1) Amiodarone hydrochloride
   (and 4 others)
4. List of Products Subject to
   Early Post-marketing Phase Vigilance

1. Initiative for the Compilation of Database-stored Data and Provision of Information concerning Pediatric Drugs
2. Important Safety Information

1. Pembrolizumab (genetical recombination)

3. Revision of Precautions (No. 294)

(1) Omarigliptin
(2) Saxagliptin hydrate
(3) Trelagliptin succinate (and 3 others)

4. List of Products Subject to
   Early Post-marketing Phase Vigilance

1. Introduction of the International Standards (ISO [IEC] 80369 series) Related to Connectors for Prevention of Interconnection
   - Switching of small-bore connectors for neuraxial anesthesia -
2. Important Safety Information

(1) Tolvaptan
(2) Anagliptin, linagliptin, teneligliptin hydrobromide hydrate, teneligliptin hydrobromide hydrate/canagliflozin hydrate
(3) Anagliptin
(4) Sterile talc

3. Revision of Precautions (No. 293)

Tolvaptan (and 5 others)

4. List of Products Subject to
   Early Post-marketing Phase Vigilance