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Post-marketing Safety Measures

MHLW Pharmaceuticals and Medical Devices Safety Information (FY2005)

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FY 2005 (No.212-223)

Japanese
version
issued
on		 No. Table of contents Posted
on		 PDF
March 23, 2006 223
  1. Important Safety Information

    (1)Selegiline Hydrochloride

  2. Revision of PRECAUTIONS (No. 174)
    Lornoxicam (and 3 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
   (Full text)
February 23, 2006 222
  1. Drug Guide for Patients
  2. Revision of PRECAUTIONS (No. 173)
    Amoxapine (and 16 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
   (Full text)
January 26, 2006 221
  1. Proper use of theophylline in childhood asthma
  2. Impact of X-ray CT apparatus etc. on implantable cardiac pacemaker etc.
  3. Revision of PRECAUTIONS (No. 172)

    (1)Ibuprofen (and 13 others)

    (2)Electrosurgical unit (ESU) used in for radiofrequency ablation (RFA)

  4. List of products subject to Early Post-marketing Phase Vigilance
   (Full text)
December 22, 2005 220
  1. Important Safety Information

    (1)Amiodarone Hydrochloride

    (2)Carboplatin

    (3)Sevoflurane

    (4)Whole Human Blood, Blood for Exchange Transfusion, Fresh-Frozen Human Plasma, Concentrated Human Blood Platelet, Concentrated Human Red Blood Cell, Concentrated Frozen-Thawed Human Red Blood Cells, Washed Human Red Blood Cells, Leukocyte Poor Red Blood Cells

    (5)Phenytoin, Phenytoin Sodium, Phenytoin / Phenobarbital, Phenytoin / Phenobarbital / Caffeine and Sodium Benzoate

  2. Revision of PRECAUTIONS (No. 171)
    Zopiclone and (12 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
   (Full text)
November 24, 2005 219
  1. Important Safety Information

    (1)Barium Sulfate (excepting preparation for CT)

    (2)Fludarabine Phosphate

  2. Revision of PRECAUTIONS (No. 170)
    Bepridil Hydrochloride (and 11 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
<Reference Material>
  1. Future Perspective of pharmacogenomics
   (Full text)
October 27, 2005 218
  1. Result of post-marketing safety measures for ticlopidine hydrochloride products with Cypher Stent
  2. Serious skin disorders induced by drugs
  3. List of products subject to Early Post-marketing Phase Vigilance
   (Full text)
September 29, 2005 217
  1. Reports etc. on adverse reactions associated with influenza vaccines in FY2004
  2. Important Safety Information

    (1)Zedoary Powder and Japanese Tangle Powder Preparation

  3. Revision of PRECAUTIONS (No. 169)
    Paroxetine Hydrochloride Hydrate (and 9 others)
  4. List of products subject to Early Post-marketing Phase Vigilance
   (Full text)
August 25, 2005 216
  1. Serious health hazards in the use of bone cement
  2. Effects on implantable medical devices (cardiac pacemakers and cardioverter defibrillators) by new system mobile phone terminals and RFID devices
  3. Important Safety Information

    (1)Sodium Valproate

    (2)Pranoprofen (oral dosage form)

    (3)Hochuekkito

  4. Revision of PRECAUTIONS (No. 168)
    Carbamazepine (and 12 others)
  5. List of products subject to Early Post-marketing Phase Vigilance
   (Full text)
July 27, 2005 215
  1. Important Safety Information

    (1)Ethionamide

    (2)Etodolac

    (3)Gemcitabine Hydrochloride

    (4)Omeprazole, Omeprazole Sodium

  2. Revision of PRECAUTIONS (No. 167)
    Tiaprofenic Acid (and 17 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
   (Full text)
June 23, 2005 214
  1. Important Safety Information

    (1)Alprostadil, Alprostadil Alfadex (20 mg injectable dosage form)

    (2)Donepezil Hydrochloride

    (3)Leuprorelin Acetate

    (4)Lopinavir / Ritonavir

  2. Revision of PRECAUTIONS (No. 166)
    Cabergoline (and 15 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
   (Full text)
May 26, 2005 213
  1. Impact of X-ray CT apparatus on implantable cardiac pacemaker (Medtronic InSync 8040)
  2. Important Safety Information

    (1)Candesartan Cilexetil, Telmisartan, Valsartan, Losartan Potassium

    (2)Ceftriaxone Sodium

    (3)Adsorbed Diphtheria-Purified Pertussisi-Tetanus Combined Vaccine

    (4)Torasemide

    (5)Japanese Encephalitis Vaccine

  3. Revision of PRECAUTIONS (No. 165)
    Fradiomycin Sulfate / Methylprednisolone Betamethasone Sodium Phosphate / Fradiomycin Sulfate (ophthalmic ointment) (and 19 others)
  4. List of products subject to Early Post-marketing Phase Vigilance
   (Full text)
April 27, 2005 212
  1. Results of investigation by the Gefitinib review meeting
  2. Overview of the notifications for self-inspection etc. issued from April 2004 to February 2005
  3. Request for cooperation in Early Post-marketing Phase Vigilance
   (Full text)