| FY 2007 (No.235-245) |
Japanese
version
issued
on |
No. |
Table of contents |
Posted
on |
PDF |
| March 27, 2008
|
245 |
- 1.
- Treatment of hepatitis viral with interferon products
- 2.
- Sudden onset of sleep, etc. associated with non-ergoline dopamine agonists (patients must be advised to refrain from driving, etc.)
- 3.
- Important Safety Information
- (1)
- Cyclophosphamide (oral dosage form), Cyclophosphamide (injectable dosage form)
- 4.
- Revision of PRECAUTIONS (No. 195)
Nicorandil (oral dosage form) and 1 other
- 5.
- List of products subject to Early Post-marketing Phase Vigilance
|
|
(Full text) |
| February 28, 2008 |
244 |
- 1.
- Revision of PRECAUTIONS (No. 194)
GEM-Premier 3000 PAK and 10 others
- 2.
- List of products subject to Early Post-marketing Phase Vigilance
|
|
(Full text) |
| January 29, 2008 |
243 |
- 1.
- Revision of PRECAUTIONS (No. 193)
Flurbiprofen (oral dosage form) and 6 others
- 2.
- List of products subject to Early Post-marketing Phase Vigilance
(Reference Material)
-
- About oseltamivir phosphate (Tamiflu)
<The brief summary of the review results by the Subcommittee on Drug Safety (held on December 25, 2007)>
|
|
(Full text) |
| December 26, 2007 |
242 |
- 1.
- Important Safety Information
- (1)
- Atorvastatin Calcium Hydrate
- (2)
- Tizanidine Hydrochloride
- (3)
- Thiamazole
- 2.
- Revision of PRECAUTIONS (No. 192)
Amitriptyline Hydrochloride and 11 others
- 3.
- List of products subject to Early Post-marketing Phase Vigilance
|
|
(Full text) |
| November 29, 2007 |
241 |
- 1.
- "PMDA medical safety information" is new posted on the Pharmaceuticals and Medical Devices Information Website
- 2.
- Important Safety Information
- (1)
- Amiodarone Hydrochloride (oral dosage form),
Amiodarone Hydrochloride (injectable dosage form)
- 3.
- Revision of PRECAUTIONS (No. 191)
- (1)
- Drugs: Pralidoxime Iodide and 13 others
- (2)
- Medical Devices: Glucose meters for self-monitoring and 5 others
- 4.
- List of products subject to Early Post-marketing Phase Vigilance
|
|
(Full text) |
| September 27, 2007 |
240 |
- 1.
- Reports etc. on adverse reactions associated with influenza vaccines in FY 2006
- 2.
- Revision of PRECAUTIONS (No. 190)
- (1)
- Telithromycin and (7 others)
- (2)
- Internal fluid pathway type needleless connectors and (1 other)
- 3.
- List of products subject to Early Post-marketing Phase Vigilance
|
|
(Full text) |
| August 30, 2007 |
239 |
- 1.
- Important Safety Information
- (1)
- Alteplase (Genetical recombination)
- (2)
- Oxycodone Hydrochloride Hydrate
- (3)
- Meropenem Trihydrate
- 2.
- Revision of PRECAUTIONS (No.189)
- (1)
- Amobarbital and (7 others)
- 3.
- List of products subject to Early Post-marketing Phase Vigilance
|
|
(Full text) |
| July 31, 2007
|
238 |
- 1.
- Important Safety Information
- (1)
- Zolpidem Tartrate
- (2)
- Zopiclone
- 2.
- Revision of PRECAUTIONS (No. 188)
- (1)
- Triazolam and (2 others)
- (2)
- Enteral feeding tubes and gastric tubes (only those with stylet or guide wire as kits) and (2 others)
- 3.
- List of products subject to Early Post-marketing Phase Vigilance
|
|
(Full text) |
| June 27, 2007
|
237 |
- 1.
- The effect from RFID devices in UHF band and mobile phone terminals with a new system on implantable medical devices such as cardiac pacemakers etc.
- 2.
- Important Safety Information
- (1)
- Gadodiamide Hydrate
- (2)
- Cabergoline
- (3)
- Pergolide Mesilate
- (4)
- Risperidone
- 3.
- Revision of PRECAUTIONS (No. 187)
- (1)
- Ampiroxicam (and 7 others)
- (2)
- Medical devices such as artificial lungs, blood pumps, and blood circuits etc.that consist of extra-corporeal circuit
- 4.
- List of products subject to Early Post-marketing Phase Vigilance
(Reference Material)
-
-
- 1.
- Manuals for Management of Individual Serious Adverse Drug Reaction
- 2.
- Guidelines for Standard Methods of Extra-corporeal Circuit and Its Safety Training
|
|
(Full text) |
| May 31, 2007
|
236 |
- 1.
- Post-marketing safety measures for ticlopidine hydrochloride products and TAXUS Express2 Stent
- 2.
- Important Safety Information
- (1)
- Edaravone
- (2)
- Amiodarone Hydrochloride (oral dosage form)
- (3)
- Cibenzoline Succinate (oral dosage form)
- 3.
- Revision of PRECAUTIONS (No. 186)
Oseltamivir Phosphate (and 11 others)
- 4.
- List of products subject to Early Post-marketing Phase Vigilance
|
|
(Full text) |
| April 26, 2007
|
235 |
- 1.
- Standardization of the number of drops for infusion sets and blood transfusion sets
- 2.
- Project of Japan Drug Information Institute in Pregnancy
- 3.
- Safety Information on the “Pharmaceuticals and Medical Devices Information Website” of the Pharmaceuticals and Medical Devices Agency
- 4.
- List of products subject to Early Post-marketing Phase Vigilance
(Reference Material)
-
-
- 1.
- Oseltamivir Phosphate
- 2.
- Overview of Pharmacogenomics
(Warfarin therapy and genetic polymorphism)
|
|
(Full text) |
