FY 2017 (No.342-351)
Japanese
version
issued
on |
No. |
Table of contents |
PDF |
March 13,
2018 |
351 |
- Medical Information Database MID-NET (Medical Information Database NETwork)
- Important Safety Information
(1) Gardenia fruit
- Revision of Precautions (No. 292)
Gardenia fruit (and 6 others)
- List of Products Subject to
Early Post-marketing Phase Vigilance
|
Full text [777 KB] |
February 6,
2018 |
350 |
- An Incident of Distribution of Counterfeit HARVONI Combination Tablets and Government Measures Against Counterfeit Drugs
- Important Safety Information
(1)[1] Teriparatide (genetical recombination), [2] Teriparatide acetate (subcutaneous injection)
(2) Edoxaban tosilate hydrate
(3) Lenvatinib mesilate
- Revision of Precautions (No. 291)
(1) Aripiprazole
(2) Aripiprazole hydrate (and 5 others)
- List of Products Subject to
Early Post-marketing Phase Vigilance
|
Full text [1.8 MB] |
December 26,
2017 |
349 |
- Safety of Influenza Antiviral Drugs
- Suspected Adverse Reactions to Influenza Vaccines in the 2016 Season
- Important Safety Information
(1) Clozapine
- Revision of Precautions (No. 290)
Clozapine (and 2 others)
- List of Products Subject to
Early Post-marketing Phase Vigilance
|
Full text [402 KB] |
November 14,
2017 |
348 |
- Initiative of Revision of the Manuals for Management of Individual Serious Adverse Drug Reactions
- Prevention of Accidents with Electric Massagers for Household Use
- Important Safety Information
(1) Levetiracetam
(2) Linagliptin
- Revision of Precautions (No. 289)
Levetiracetam (and 8 others)
- List of Products Subject to
Early Post-marketing Phase Vigilance
|
Full text [920 KB] |
October 10,
2017 |
347 |
- Summary of the Relief System for Adverse Drug Reaction and Request of Cooperation for the System
- Important Safety Information
(1) Dabigatran etexilate methanesulfonate
- Revision of Precautions (No. 288)
Dabigatran etexilate methanesulfonate
(and 2 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
|
Full text [259 KB] |
September 5,
2017 |
346 |
- The Expert Committee on Quality of Generic Drug Products
- Introduction of the “My Drug List for Safety Updates” service
- Revision of Precautions (No. 287)
Riociguat (and 4 others)
- List of Products Subject to
Early Post-marketing Phase Vigilance
|
Full text [1.4 MB] |
August 1,
2017 |
345 |
- Summary of Guidance for Adverse Drug Reaction Reporting by Medical and Pharmaceutical Providers
- Important Safety Information
(1) Loxoprofen sodium hydrate (dermatologic preparation)
(2) Fluconazole, Fosfluconazole
(3) Nivolumab (genetical recombination)
- Revision of Precautions (No. 286)
Loxoprofen sodium hydrate
(dermatologic preparation)(and 16 others)
- List of Products Subject to
Early Post-marketing Phase Vigilance
|
Full text [650 KB] |
June 27,
2017 |
344 |
- Revision of Instructions for Package Inserts of Prescription Drugs
- Precautions Concerning Recurrent and Similar Medical Accidents
- Important Safety Information
(1) Treprostinil
(2) Bosutinib
- Revision of Precautions (No. 285)
Treprostinil (and 3 others)
- List of Products Subject to
Early Post-marketing Phase Vigilance
|
Full text [533 KB] |
May 23,
2017 |
343 |
- Project of the Japan Drug Information Institute in Pregnancy
- Revision of Precautions (No. 284)
Denosumab (and 2 others)
- List of Products Subject to
Early Post-marketing Phase Vigilance
|
Full text [312 KB] |
April 18,
2017 |
342 |
- Precautions for Dependence Associated with Hypnotics-Sedatives, Anxiolytics, and Antiepileptics
- Optimal Clinical Use Guidelines
- Important Safety Information
(1) Aluminum potassium sulfate hydrate/Tannic acid
- Revision of Precautions (No. 283)
Lamotrigine (and 37 others)
- List of Products Subject to
Early Post-marketing Phase Vigilance
|
Full text [528 KB] |
