FY 2011 (No.279-289)
Japanese
version
issued
on |
No. |
Table of contents |
PDF |
| March 28, 2012 |
289 |
- Reactivation of Hepatitis B Virus Associated with Antineoplastic Agent Everolimus
- Use of the "PMDA medi-navi" and "My Drug List for Safety Update"
- Important Safety Information
(1)Montelukast Sodium
(2)Monobasic Sodium Phosphate Monohydrate / Dibasic Sodium Phosphate Anhydrous
- Revision of Precautions (No. 234)
(1)Leflunomide (and 5 others)
(2)Radiation Therapy Equipment
- List of Products Subject to Early Post-marketing Phase Vigilance (as of March 2012)
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Full text [477 KB] |
| February 29, 2012 |
288 |
- Systemic Allergy Associated with the Use of Quasi-drugs / Cosmetics
- Important Safety Information
(1)Daikenchuto
- Revision of Precautions (No. 233)
Galsulfase (Genetical Recombination) (and 13 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of February 2012)
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Full text [396 KB] |
| January 25, 2012 |
287 |
- Lamotrigine-induced Severe Drug Eruption and Compliance with Dosage and Administration
- Fatal Accidents Involving Patients during Use of Long-term Oxygen Therapy
- List of Products Subject to Early Post-marketing Phase Vigilance (as of January 2012)
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Full text [197 KB] |
| December 27, 2011 |
286 |
- Cases of Non-payment under the Relief System for Sufferers from Adverse Drug Reactions and Proper Use of Drugs
- Important Safety Information
(1)Epoprostenol Sodium
- Revision of Precautions (No. 232)
Solifenacin Succinate (and 7 others)
- List of Products Subject to Early Post-marketing Phase Vigilance (as of December 2011)
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Full text [415 KB] |
| November 30, 2011 |
285 |
- Safety Measures against Nephrogenic Systemic Fibrosis associated with Gadolinium Contrast Media
- Carbamazepine-induced Serious Drug Eruption and Genetic Polymorphism
- Important Safety Information
(1)Anastrozole
(2)Temozolomide
(3)Ritodrine hydrochloride (injectable dosage form)
- Revision of Precautions (No. 231)
Atomoxetine Hydrochloride (and 6 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
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Full text [592 KB] |
| October 26, 2011 |
284 |
- Safety Measures against Disturbed Consciousness Associated with the Use of Smoking Cessation Aid CHAMPIX Tablets
- The Guidelines for Provision of Dear Healthcare Professional Letters of Emergent / Rapid Safety Communications
- Summary of the Report on Adverse Reactions to the Influenza A (H1N1) Vaccine in the 2010 Season
- Important Safety Information
(1)Voriconazole
- Revision of Precautions (No. 230)
Gadoxetate Sodium (and 11 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
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Full text [335 KB] |
| September 28, 2011 |
283 |
- Safety Measures against Bladder Cancer Associated with Diabetes Medication "Pioglitazone Hydrochloride-Containing Products"
- Important Safety Information
(1)Influenza HA Vaccine
(2)Thalidomide
(3)Doxorubicin Hydrochloride (non-liposome preparation)
(4)Dabigatran Etexilate Methanesulfonate
- Revision of Precautions (No. 229)
Modafinil (and 16 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
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Full text [651 KB] |
| August 30, 2011 |
282 |
- Revision of Contraindications for the Use of Coronary Stent
- Revision of Contraindications for the Use of Intraocular Lens
- Important Safety Information
(1)Oxaliplatin
(2)Recombinant Adsorbed Hepatitis B Vaccine (yeast-derived) (Bimmugen))
(3)Sunitinib Malate
(4)Pneumococcal Polysaccharide Conjugate Vaccine (adsorbed)
(5)Varenicline Tartrate
(6)Lenalidomide Hydrate
- Revision of Precautions (No. 228)
Pioglitazone Hydrochloride (and 8 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
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Full text [494 KB] |
| July 27, 2011 |
281 |
- Revision of Package Inserts of Subcutaneous Port and Catheter
- Important Safety Information
(1)Freeze-dried Live Attenuated Measles Vaccine; Freeze-dried Live Attenuated Measles, Rubella Combined Vaccine
(2)Cisplatin (intra-arterial injection)
(3)Sitagliptin Phosphate Hydrate
(4)Sorafenib Tosilate
(5)Metformin Hydrochloride (products with "Dosage and Administration" of maximum daily dosage of 2250mg)
- Revision of Precautions (No. 227)
Cortisone Acetate (and 9 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
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Full text [559 KB] |
| June 29, 2011 |
280 |
- Safety Measures for Pediatric Pneumococcal Conjugate Vaccine and Haemophilius Influenzae Type b (Hib) Vaccine
- Manuals for Management of Individual Serious Adverse Drug Reactions
- Important Safety Information
(1)Olopatadine Hydrochloride (oral dosage form)
(2)Fludarabine Phosphate
(3)Miriplatin hydrate, iodine addition products of the ethylesters of the fatty acids obtained from poppyseed oil (MIRIPLA suspension vehicle)
- Revision of Precautions (No. 226)
Ketotifen Fumarate (oral dosage form) (and 12 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
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Full text [529 KB] |
| May 25, 2011 |
279 |
- Project of Japan Drug Information Institute in Pregnancy
- Safety Measures Related to Lenalidomide Hydrate
- Important Safety Information
(1)Aripiprazole
(2)Freeze-dried Live Attenuated Mumps Vaccine
(3)Anti-human Thymocyte Immunoglobulin, Rabbit
(4)Tacrolimus Hydrate (oral and injectable dosage form)
(5)Tolvaptan
(6)Pioglitazone Hydrochloride, Pioglitazone Hydrochloride / Glimepiride, Pioglitazone Hydrochloride / Metformin Hydrochloride
- Revision of Precautions (No. 225)
Sanilvudine (and 32 others)
- List of Products Subject to Early Post-marketing Phase Vigilance
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Full text [668 KB] |
