FY 2014 (No.312-321)
Japanese
version
issued
on |
No. |
Table of contents |
PDF |
| March 30, 2015 |
321 |
- Lamotrigine and Serious Skin Disorders
- Abiraterone Acetate and Hypokalaemia
- The MIHARI Project
- Important Safety Information
(1)abiraterone acetate
(2)lamotrigine
(3)apixaban
(4)memantine hydrochloride
- Revision of Precautions (No. 263)
Montelukast sodium and telaprevir
- List of Products Subject to Early Post-marketing Phase Vigilance (as of March 2015)
(Reference)
The Drug and Medical Devices Safety Information Reporting System
– Reporting via e-Gov was closed |
Full text [364 KB] |
January
29, 2015 |
320 |
- Cabazitaxel Acetonate and Severe Febrile Neutropenia
- Use of Capsule Endoscopy for Small Intestine Screening in Pediatrics and Geriatrics
- Important Safety Information
(1)cabazitaxel acetonate
(2)sodium-glucose co-transporter 2 inhibitors
(3)freeze-dried live attenuated mumps virus vaccine
(4)levetiracetam
- Revision of Precautions (No. 262)
Linagliptin (and 2 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of January 2015)
|
Full text [329 KB] |
December
24, 2014 |
319 |
- Summary of the Relief System for Sufferers from Adverse Drug Reactions and the Cases of Non-payment of Relief Benefits Due to Improper Use of Drugs
- Revision of Precautions (No. 261)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of December 2014)
(Reference)
Handling of Fire during Long-term Oxygen Therapy
|
Full text [583 KB] |
| November 25, 2014 |
318 |
- Simeprevir Sodium and Hyperbilirubinaemia
- Surveillance on Access to, Dissemination, and Utilization of Drug Safety Information in Medical Institutions and Pharmacies
- Adverse Reactions to Influenza Vaccine in the 2013 Season
- Important Safety Information
(1)Enzalutamide
(2)Teneligliptin hydrobromide hydrate
(3)Vancomycin hydrochloride (for injection)
(4)Simeprevir sodium
- Revision of Precautions (No. 260)
Acetaminophen and vancomycin hydrochloride (oral dosage form)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of November 2014)
|
Full text [1.2 MB] |
October
28, 2014 |
317 |
- Guidelines for Use of Mobile Phones and Other Devices in Hospitals
- Change in the Submission Place of Reports in the Safety Information Reporting System
- Important Safety Information
(1)Imatinib mesilate
(2)Pregabalin
- List of Products Subject to Early Post-marketing Phase Vigilance (as of October 2014)
|
Full text [394 KB] |
| September 30, 2014 |
316 |
- Project of Japan Drug Information Institute in Pregnancy
- Effects of Angiotensin II Receptor Blockers and Angiotensin Converting Enzyme Inhibitors on Pregnant Women and Foetuses
- Revision of Precautions (No. 259)
Paroxetine Hydrochloride Hydrate (and 9 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of September 2014)
|
Full text [524 KB] |
| August 26, 2014 |
315 |
- Safety Measures of New Drugs during the Early Post-marketing Phase
- Important Safety Information
(1)Inchinkoto
(2)Simeprevir Sodium
(3)Teriparatide (Genetical Recombination)
(4)Loratadine
- Revision of Precautions (No. 258)
Paroxetine Hydrochloride Hydrate (and 3 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of August 2014)
|
Full text [315 KB] |
July 29,
2014 |
314 |
- Revision of Report Form in Drugs and Medical Devices Safety Information Reporting System
- Revision of Precautions (No. 257)
(1)Azilsartan (and 7 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of July 2014)
|
Full text [199 KB] |
May 27,
2014 |
313 |
- Fatal cases with XEPLION® Aqueous Suspension for IM injection
- Important Safety Information
(1)Paliperidone Palmitate
- Revision of Precautions (No. 256)
(1)Pentamidine Isetionate
- List of Products Subject to Early Post-marketing Phase Vigilance (as of May 2014)
|
Full text [186 KB] |
April 30,
2014 |
312 |
- Use of Topical Ketoprofen during Pregnancy
- Important Safety Information
(1)Ketoprofen (tapes)
(2)Paclitaxel (excluding paclitaxel protein-bound particles for injectable suspension)
(3)Levetiracetam
- Revision of Precautions (No. 255)
(1)Ketoprofen (injectable dosage form, suppository) (and 7 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of April 2014)
|
Full text [324 KB] |
