MHLW Pharmaceuticals and Medical Devices Safety Information (FY2018)

1. Genome Research relating to Drug-induced Muscle Disorders
2. Important Safety Information

1. Trastuzumab (genetical recombination) and other follow-on biologics
2. Nivolumab (genetical recombination)
3. Palbociclib
4. Pembrolizumab (genetical recombination)

3. Revision of Precautions (No. 301)

   Eliglustat tartrate (and 5 others)

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

1. Package Inserts of Prescription Drugs under the Revised Instructions
2. Important Safety Information

1. Nusinersen sodium
2. Axitinib

3. Revision of Precautions (No. 300)
   Nusinersen sodium (and 5 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance

1. Safety of Influenza Antiviral Drugs
2. Suspected Adverse Reactions to Influenza vaccines in the 2017 Season
3. Important Safety Information

1. (1) Aluminum potassium sulfate hydrate/tannic acid (with saline)
    (2) Aluminum potassium sulfate hydrate/tannic acid (with analgesic agents)
2. Calcitriol (injectable dosage form)
3. Freeze-dried live attenuated varicella vaccine

4. Revision of Precautions (No. 299)
   Aluminum potassium sulfate hydrate/tannic acid (with saline)(and 3 others)
5. List of Products Subject to Early Post-marketing Phase Vigilance

1. Safety Measures for Influenza Antiviral Drugs
2. Results of a Survey Investigating Access, Communication, and Utilization of Drug Safety Information at Hospitals and Pharmacies and Desirable Directions
3. Important Safety Information

1. Secukinumab (genetical recombination)
2. Lamotrigine
3. Lenvatinib mesilate

4. 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)

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

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