Japanese
version
issued
on |
No. |
Table of contents |
PDF |
| March 27, 2013 |
300 |
- Implementation of the "Risk Management Plan"
- Revision of Precautions (No. 244)
Estradiol (ESTRANA, Julina, DIVIGEL, FEMIEST) (and 4 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of March 2013)
|
Full text [590 KB] |
| February 27, 2013 |
299 |
- Utilization of the PMDA Medical Safety Information
- Important Safety Information
(1)Zanamivir Hydrate
(2)Josamycin, Josamycin Propionate
(3)Sunitinib Malate
(4)Ryutanshakanto (for Ethical Use)
- Revision of Precautions (No. 243)
Glimepiride, Pioglitazone Hydrochloride / Glimepiride (and 4 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of February 2013)
<Reference>
Adverse Drug Reaction Term "Anaphylaxis" |
Full text [870 KB] |
| January 30, 2013 |
298 |
- Partial Amendment of the "Guidance for Bar Code Labeling on Prescription Drugs" for the Prevention of Medical Accidents
- Important Safety Information
(1)Temozolomide
(2)Telaprevir
(3)Pramipexole Hydrochloride Hydrate
(4)Mogamulizumab
- Revision of Precautions (No. 242)
Digoxin, Deslanoside, and Methyldigoxin (and 5 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of January 2013)
|
Full text [708 KB] |
| December 26, 2012 |
297 |
- Surveillance on Dissemination and Utilization of Safety Information in Medical Institutions
- Precautions for Using Gastrointestinal Stents
- List of Products Subject to Early Post-
marketing Phase Vigilance (as of December 2012)
|
Full text [950 KB] |
| November 27, 2012 |
296 |
- Summary of Payment / Non-payment of Adverse Drug Reaction Relief Benefits and Drugs with Many Cases of Improper Use
- Important Safety Information
(1)Imatinib Mesilate
(2)Ceftriaxone Sodium Hydrate
(3)Mexiletine Hydrochloride
- Revision of Precautions (No. 241)
Inactivated Poliomyelitis Vaccine (and 4 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of November 2012)
|
Full text [513 KB] |
| October 31, 2012 |
295 |
- Serious Hypocalcaemia Associated with Denosumab (Genetical Recombination)
- Important Safety Information
(1)Denosumab (Genetical Recombination)
(2)Tetracosactide Acetate (0.5 mg preparation)
(3)Levocabastine Hydrochloride
- Revision of Precautions (No. 240)
Diclofenac Sodium (ophthalmic solution) (and 9 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of October 2012)
|
Full text [405 KB] |
| September 26, 2012 |
294 |
- Proper Use of Contact Lenses and Prevention of Eye Disorders
- Summary of Report on Adverse Reactions to the Influenza Vaccine in the 2011 Season
- Important Safety Information
(1)Oxaliplatin
- Revision of Precautions (No. 239)
Suxamethonium Chloride Hydrate (and 6 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of September 2012)
|
Full text [426 KB] |
| August 29, 2012 |
293 |
- Serious Adverse Reactions Associated with Over-the-counter Drugs
- Important Safety Information
(1)Pregabalin
(2)Methotrexate (Tablet 2 mg, Capsule)
(3)Influenza HA Vaccine
- Revision of Precautions (No. 238)
Metformin Hydrochloride (and 9 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of Aug 2012)
|
Full text [436 KB] |
| July 25, 2012 |
292 |
- Launch of a pilot program of "Direct Patient Reporting System for Adverse Drug Reactions"
- Important Safety Information
(1)Ivermectin
(2)Telaprevir
(3)Garenoxacin Mesilate Hydrate
- Revision of Precautions (No. 237)
Escitalopram Oxalate (and 6 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of July 2012)
|
Full text [1,081 KB] |
| June 27, 2012 |
291 |
- Safety Measures for Cervical Cancer Prevention Vaccines
- Important Safety Information
(1)Alogliptin Benzoate, Alogliptin Benzoate / Pioglitazone Hydrochloride, Sitagliptin Phosphate Hydrate, Vildagliptin, Linagliptin
(2)Exenatide, Liraglutide (Genetical Recombination)
(3)Mosapride Citrate Hydrate
(4)Iodine
- Revision of Precautions (No. 236)
Ibuprofen (oral dosage form) (and 29 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of June 2012)
|
Full text [523 KB] |
| April 25, 2012 |
290 |
- Lookback Study on Blood Products for Transfusion
- Drug-induced Serious Skin Disorders
- Important Safety Information
(1)Products Containing Acetaminophen
(2)Cibenzoline Succinate
(3)Triclofos Sodium, Chloral Hydrate
(4)Metformin Hydrochloride (products with "Dosage and Administration" of maximum daily dosage of 2250 mg)
- Revision of Precautions (No. 235)
Pioglitazone Hydrochloride / Metformin Hydrochloride (and 14 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of April 2012)
<Reference>
Increase of the Number of Cooperating Hospitals in the Project for "Japan Drug Information Institute in Pregnancy" |
Full text [736 KB] |
