MHLW Pharmaceuticals and Medical Devices Safety Information

FY 2008 (No.246-256)
Japanese
version
issued
on		 No. Table of contents Posted
on		 PDF
March 26, 2009 256
1.
Skin necrosis/ulcer following injection of hydroxyzine hydrochloride
2.
Important Safety Information
(1)
Tocilizumab (Genetical recombination)
3.
List of products subject to Early Post-marketing Phase Vigilance
 April 20, 2009 PDF
(Full text)
February 26, 2009 255
1.
Important Safety Information
(1)
Sorafenib Tosilate
(2)
Etanercept (genetical recombination)
(3)
Temozolomide
(4)
Rituximab (genetical recombination)
2.
Revision of PRECAUTIONS (No. 204)
Aripiprazole (and 13 others)
3.
List of products subject to Early Post-marketing Phase Vigilance
  (Reference Material)
 
Precautions regarding abnormal behaviour when infected with influenza
March 13, 2009 PDF
(Full text)
January 29, 2009 254
1.
Pharmaceuticals and Medical Devices Information E-mail Alert Service
2.
Important Safety Information
(1)
Enteral nutrition (Elental, Elental P, Ensure・H, Ensure Liquid, Enterued, Twinline, Harmonic-F, Harmonic-M, Racol)
(2)
Lornoxicam
3.
Revision of PRECAUTIONS (No. 203)
Ergotamine Tartrate・Anhydrous Caffeine (and 6 others)
4.
List of products subject to Early Post-marketing Phase Vigilance
 February 18, 2009 PDF
(Full text)
December 18, 2008 253
1.
Revision of PRECAUTIONS (No. 202)
(1)
Amantadine Hydrochloride (and 3 others)
(2)
Insulin Pen
2.
List of products subject to Early Post-marketing Phase Vigilance
January 9, 2009 PDF
(Full text)
November 27, 2008 252
1.
Hypermagnesaemia following the administration of magnesium oxide
2.
Important Safety Information
(1)
Azelnidipine
3.
Revision of PRECAUTIONS (No. 201)
(1)
Bromocriptin Mesilate (and 13 others)
(2)
Ureteral Stent
4.
List of products subject to Early Post-marketing Phase Vigilance
 November 27, 2008 PDF
(Full text)
October 30, 2008 251
1.
Adverse Drug Reaction Relief System and Relief System for Infections Derived from Biological Products
2.
Airway clogging of heat and moisture exchangers due to use in combination with heated humidifier
3.
List of products subject to Early Post-marketing Phase Vigilance
  (Reference Material)
 
Reports on adverse reactions associated with influenza vaccines in FY 2007
(Conclusion of the vaccine adverse reaction review committee)
November 28, 2008 PDF
(Full text)
September　25, 2008 250
1.
Interstitial pneumonia from interferon preparations (preparations with the indication for “improvement of viraemia in chronic hepatitis C”)
2.
Revision of PRECAUTIONS (No. 200)
Gefitinib (and 9 others)
3.
List of products subject to Early Post-marketing Phase Vigilance
  (Reference Material)
 
Results of the Gefitinib domestic phase III study and opinions on Gefitinib use etc
October 21, 2008 PDF
(Full text)
August 28, 2008 249
1.
Important Safety Information
(1)
Tiotropium Bromide Hydrate
2.
Revision of PRECAUTIONS (No. 199)
Bucillamine and (5 others)
3.
List of products subject to Early Post-marketing Phase Vigilance
 September 12, 2008 PDF
(Full text)
July 23, 2008 248
1.
Revision of PRECAUTIONS (No. 198)
(1)
Bepridil Hydrochloride (and 1 other)
2.
List of products subject to Early Post-marketing Phase Vigilance
   PDF
(Full text)
June 26, 2008 247
1.
Revision of PRECAUTIONS (No. 197)
(1) Carbamazepine (and 3 others)
2.
List of products subject to Early Post-marketing Phase Vigilance
  (Reference Material)
 
Information on Heparin Sodium Products etc.
   PDF
(Full text)
May 22, 2008 246
1.
Revision of PRECAUTIONS (No. 196)
(1)
Desmopressin Acetate (drug products with the indication for nocturnal enuresis) and 4 others
(2)
Coronary drug-eluting stent
2.
List of products subject to Early Post-marketing Phase Vigilance
  (Reference Material)
 
1.
Manuals for Management of Individual Serious Adverse Drug Reactions
2.
Increasing the number of cooperating hospitals in the project for “Japan Drug Information Institute in Pregnancy”
   PDF
(Full text)