FY 2013 (No.301-311)
Japanese
version
issued
on |
No. |
Table of contents |
PDF |
| March 26, 2014 |
311 |
- Revised Adverse Reaction Reporting System for Quasi-drugs and Cosmetics
- Important Safety Information
(1)Salazosulfapyridine
(2)Sulfamethoxazole/Trimethoprim
(3)Felbinac (for ethical use)
(4)Regorafenib Hydrate
- Revision of Precautions (No. 254)
(1)Mianserin Hydrochloride (and 5 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of March 2014)
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Full text [291 KB] |
| February 27, 2014 |
310 |
- Thrombosis with YAZ Combination Tablets for Dysmenorrhea
- Rivaroxaban and Interstitial Pneumonia
- Direct Patient Reporting System for Adverse Drug Reactions
- Important Safety Information
(1)Atazanavir Sulfate
(2)Crizotinib
(3)Clopidogrel Sulfate-containing Products
(4)Sodium Valproate
(5)Drospirenone/Ethinylestradiol Betadex
(6)Rivaroxaban
- Revision of Precautions (No. 253)
(1)Rufinamide (and 8 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of February 2014)
|
Full text [647 KB] |
| January 29, 2014 |
309 |
- Precautions for Use of Puncture Site Closure Devices
- List of Products Subject to Early Post-marketing Phase Vigilance (as of January 2014)
(Reference)
Drugs and Medical Devices Safety Information Reporting System |
Full text [322 KB] |
| December 26, 2013 |
308 |
- Review of Driving Precautions in Package Inserts of Ethical Drugs
- Important Safety Information
(1)Bosentan Hydrate
- Revision of Precautions (No. 252)
(1)Donepezil Hydrochloride (and 5 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of December 2013)
(Reference)
Handling of Fire during Long-term Oxygen Therapy |
Full text [355 KB] |
| November 28, 2013 |
307 |
- 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
- Important Safety Information
(1)Axitinib
(2)Bevacizumab (Genetical Recombination)
- Revision of Precautions (No. 251)
(1)Clobazam (and 9 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of November 2013)
|
Full text [606 KB] |
| October 30, 2013 |
306 |
- Adverse Reactions to Influenza Vaccine in the 2012 Season
- Important Safety Information
(1)Propylthiouracil
(2)Bortezomib
(3)Minocycline Hydrochloride (oral dosage form, injectable dosage form)
(4)Losartan Potassium
- Revision of Precautions (No. 250)
(1)Celecoxib (and 4 others)
(2)Tracheostomy Masks
- List of Products Subject to Early Post-marketing Phase Vigilance (as of October 2013)
|
Full text [407 KB] |
| September 25, 2013 |
305 |
- Hydroxyethyl Starch-containing Solutions and Renal Impairment
- Project of Japan Drug Information Institute in Pregnancy
- Important Safety Information
(1)Alogliptin Benzoate-containing products
(2)Valsartan-containing products
(3)Vildagliptin
(4)Orengedokuto, Kamishoyosan and Shin' iseihaito
- Revision of Precautions (No. 249)
Isoflurane (and 13 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of September 2013)
|
Full text [662 KB] |
| August 28, 2013 |
304 |
- Surveillance on Availability, Dissemination, and Utilization of Drug Safety Information in Medical Institutions and Pharmacies
- Important Safety Information
(1)Golimumab (Genetical Recombination)
- Revision of Precautions (No. 248)
Paliperidone (and 5 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of August 2013)
|
Full text [687 KB] |
| July 31, 2013 |
303 |
- Tolvaptan and Hepatic Dysfunction
- Revision of Precautions for Magnetic Resonance Imaging System
- Important Safety Information
(1)Interferon beta (Products for administration in combination with ribavirin) and Ribavirin (Capsules)
(2)Carboplatin
(3)Tegafur / Gimeracil / Oteracil Potassium
(4)Tolvaptan
(5)Paroxetine Hydrochloride Hydrate
(6)Levetiracetam
- Revision of Precautions (No. 247)
Loxoprophen sodium hydrate (oral dosage form) (and 4 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of July 2013)
|
Full text [505 KB] |
| June 26, 2013 |
302 |
- Severe Haemorrhages Associated with Suspected Interaction between Antirheumatic Iguratimod and Warfarin
- Revision of Precautions for the Effect of Battery Chargers for Electric Cars on Implantable Cardiac Pacemakers
- Important Safety Information
(1)Ambrisentan
(2)Tranexamic Acid
(3)Iguratimod
- Revision of Precautions (No. 246)
(1)Tolvaptan (and 12 others)
(2)Magnetic Resonance Imaging
- List of Products Subject to Early Post-marketing Phase Vigilance (as of June 2013)
|
Full text [475 KB] |
| May 28, 2013 |
301 |
- Precautions in Handling of Reusable Resuscitator
- Important Safety Information
(1)Recombinant Absorbed Bivalent Human Papillomavirus-like Particle Vaccine (derived from Trichoplusia ni cells)
(2)Telaprevir
- Revision of Precautions (No. 245)
(1)Gabapentin (and 19 others)
(2)Implantable Cardiac Pacemaker, Biventricular Pacing Pulse Generator without Defibrillator Function
- List of Products Subject to Early Post-marketing Phase Vigilance (as of May 2013)
|
Full text [744 KB] |
