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Post-marketing Safety Measures

MHLW Pharmaceuticals and Medical Devices Safety Information (FY2008)

FY 2008 (No.246-256)

Japanese
version
issued
on
No. Table of contents 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
Full text [415 KB]
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>
  1. Precautions regarding abnormal behaviour when infected with influenza
Full text [447 KB]
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
Full text [419 KB]
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
Full text [202 KB]
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
Full text [470 KB]
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>
  1. Reports on adverse reactions associated with influenza vaccines in FY 2007
    (Conclusion of the vaccine adverse reaction review committee)
Full text [425 KB]
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>
  1. Results of the Gefitinib domestic phase III study and opinions on Gefitinib use etc.
Full text [314 KB]
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
Full text [357 KB]
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
Full text [311 KB]
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>
  1. Information on Heparin Sodium Products etc.
Full text [347 KB]
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>
  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"
Full text [381 KB]