MHLW Pharmaceuticals and Medical Devices Safety Information (FY2015)

1. “Children and Medicines” Data Collecting Network Development Project
2. Important Safety Information

(1)Eribulin mesilate

3. Revision of Precautions (No. 272)

Methylphenidate hydrochloride (and 2 others)

4. List of Products Subject to Early Post-marketing Phase Vigilance (as of February 2016)

1. Preventative Measures for Accidental Ingestion of Pharmaceuticals by Children
2. Important Safety Information

(1)Amlodipine besilate

(2)Itraconazole

3. Revision of Precautions (No. 271)

Azilsartan(and 12 others)

4. List of Products Subject toEarly Post-marketing Phase Vigilance (as of December 2015)

1. Adverse Reaction to Influenza Vaccine in the 2014 Season
2. Safety of Influenza Antiviral Drugs
3. Important Safety Information

(1)Lenvatinib mesilate

4. Revision of Precautions (No. 270)

Fomepizole (and 3 others)

5. List of Products Subject to Early Post-marketing Phase Vigilance (as of November 2015)

Precautions Regarding Handling of Fire during Long-Term Oxygen Therapy (LOT)

1. Hypermagnesaemia caused by magnesium oxide
2. Summary of the Relief System for Sufferers from Adverse Drug Reaction and Cases of Non-payment of Relief Benefits Due to Improper Use of Drugs
3. The Japan Drug Information Institute in Pregnancy
4. Important Safety Information

(1)asunaprevir and daclatasvir hydrochloride

5. Revision of Precautions (No. 269)

6. List of Products Subject to Early Post-marketing Phase Vigilance (as of October 2015)

1. Utilization of Blood Glucose Meters, etc. that Use Enzymatic Electrodes
2. Precautions Concerning Recurrent and Similar Incidents of Medical Accidents
3. Important Safety Information

(1)asunaprevir and daclatasvir hydrochloride

(2)amantadine hydrochloride

(3)nivolumab (genetical recombination)

(4)sodium-glucose co-transporter 2 (SGLT2) inhibitors

4. Revision of Precautions (No. 268)

5. List of Products Subject to Early Post-marketing Phase Vigilance (as of September 2015)

1. Epidemiological Survey on Vaccination and Sudden Death of Infants
2. Important Safety Information

(1)sterile talc

(2)panitumumab (genetical recombination)

3. Revision of Precautions (No. 267)

4. List of Products Subject to Early Post-marketing Phase Vigilance (as of August 2015)

1. Surveillance on Access to, Dissemination, and Utilization of Drug Safety Information in Medical Institutions
2. Important Safety Information

(1)asunaprevir and daclatasvir hydrochloride

(2)abiraterone acetate

(3)indapamide

(4)influenza HA vaccine

(5)interferon beta-1a (genetical recombination)

3. Revision of Precautions (No. 266)

4. List of Products Subject to Early Post-marketing Phase Vigilance (as of June 2015)

1. Risk Management Plan
2. Important Safety Information

(1)crizotinib
(2)technetium (^99mTc) hydroxymethylenediphosphonate injection, kit for the preparation of technetium (^99mTc) hydroxymethylenediphosphonate injection

3. List of Products Subject to Early Post-marketing Phase Vigilance (as of May 31, 2015)

1. Utilization of New Bar Code Labeling and Termination of JAN/ITF Code Labeling on Prescription Drugs
2. Important Safety Information

(1)asunaprevir and daclatasvir hydrochloride

3. Revision of Precautions (No. 265)

4. List of Products Subject to Early Post-marketing Phase Vigilance (as of April 30,2015)

1. Adherence to the Cleaning and Disinfection Method to Prevent Transmission of Multidrug-resistant Bacteria by Duodenoscope
2. Important Safety Information

(1)cyclophosphamide hydrate

(2)sitagliptin phosphate hydrate

(3)triamcinolone acetonide (intramuscular, intra-articular, and intradermal)

(4)pazopanib hydrochloride

(5)panitumumab (genetical recombination)

3. Revision of Precautions (No. 264)

4. List of Products Subject to Early Post-marketing Phase Vigilance (as of April 2015)

Precautions Concerning Recurrence and Similar Incidents of Medical Accidents