Date |
Nonproprietary name
(Click on each drug name for more information
[only in Japanese]) |
Detailed information on revisions of PRECAUTIONS
(from MHLW) |
Summary of
investigation results
(from PMDA) |
Reference article (Important Safety Information) in Pharmaceuticals and Medical Devices Safety Information (PMDSI) |
January 29, 2025 |
|
PRECAUTIONS
[14.3 KB] |
Summary of
Investigation
[95.2 KB] |
- |
|
PRECAUTIONS
[14.8 KB] |
Summary of
Investigation
[95.2 KB] |
- |
|
PRECAUTIONS
[14.0 KB] |
Summary of
Investigation
[95.2 KB] |
- |
|
PRECAUTIONS
[89.0 KB] |
Summary of
Investigation
[80.7 KB] |
- |
|
PRECAUTIONS
[13.0 KB] |
Summary of
Investigation
[29.7 KB] |
- |
December 17, 2024 |
|
PRECAUTIONS
[31.1 KB] |
Report on
Investigation
[134 KB]
Appendix 3 is not included in this file. See PRECAUTIONS. |
- |
|
PRECAUTIONS
[75.8 KB] |
Report on
Investigation
[134 KB]
Appendix 3 is not included in this file. See PRECAUTIONS. |
- |
|
PRECAUTIONS
[14.7 KB] |
Summary of
Investigation
[166 KB] |
PMDSI No.416 |
|
PRECAUTIONS
[25.6 KB] |
Summary of
Investigation
[37.2 KB] |
PMDSI No.416 |
|
PRECAUTIONS
[22.0 KB]
PRECAUTIONS
[22.0 KB] |
Summary of
Investigation
[48.3 KB] |
- |
|
PRECAUTIONS
[139 KB]
PRECAUTIONS
[21.5 KB]
PRECAUTIONS
[20.7 KB] |
Summary of
Investigation
[48.3 KB] |
- |
- Potassium iodide
(preparations indicated for prevention/reduction of internal exposure of the thyroid gland to radioactive iodine)
- Potassium iodide
(preparations indicated for prevention/reduction of internal exposure of the thyroid gland to radioactive iodine)
|
PRECAUTIONS
[30.7 KB] |
Report on
Investigation
[134 KB]
Appendix 3 is not included in this file. See PRECAUTIONS. |
- |
- Potassium iodide
(preparations indicated for prevention/reduction of internal exposure of the thyroid gland to radioactive iodine)
|
PRECAUTIONS
[26.3 KB] |
Report on
Investigation
[134 KB]
Appendix 3 is not included in this file. See PRECAUTIONS. |
- |
|
PRECAUTIONS
[14.3 KB] |
Summary of
Investigation
[166 KB] |
PMDSI No.416 |
|
PRECAUTIONS
[14.3 KB] |
Summary of
Investigation
[166 KB] |
PMDSI No.416 |
|
PRECAUTIONS
[14.5 KB] |
Summary of
Investigation
[166 KB] |
PMDSI No.416 |
|
PRECAUTIONS
[13.6 KB] |
Summary of
Investigation
[35.0 KB] |
PMDSI No.416 |
|
PRECAUTIONS
[14.4 KB] |
Summary of
Investigation
[32.7 KB] |
PMDSI No.416 |
|
PRECAUTIONS
[18.6 KB] |
(References) Material for the 2024 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs Council (the 9th meeting) (only in Japanese) |
- |
|
PRECAUTIONS
[18.7 KB] |
(References) Material for the 2024 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs Council (the 9th meeting) (only in Japanese) |
- |
November 13, 2024 |
|
PRECAUTIONS
[13.7 KB] |
Summary of
Investigation
[26.2 KB] |
- |
|
PRECAUTIONS
[14.6 KB] |
Summary of
Investigation
[30.4 KB] |
PMDSI No.415 |
|
PRECAUTIONS
[13.4 KB]
|
Summary of
Investigation
[25.4 KB] |
- |
|
PRECAUTIONS
[21.9 KB] |
Summary of
Investigation
[26.7 KB] |
- |
|
PRECAUTIONS
[21.6 KB] |
Summary of
Investigation
[26.7 KB] |
- |
|
PRECAUTIONS
[14.5 KB] |
Summary of
Investigation
[26.7 KB] |
- |
|
PRECAUTIONS
[13.4 KB] |
Summary of
Investigation
[85.0 KB] |
- |
|
PRECAUTIONS
[14.0 KB] |
Summary of
Investigation
[42.6 KB] |
- |
- Ethyl icosapentate (OTC drug)
|
PRECAUTIONS
[14.4 KB] |
Summary of
Investigation
[23.5 KB] |
- |
October 8, 2024 |
- Aspirin
(preparations
indicated for
antipyresis/analgesia/
anti-inflammation)
|
PRECAUTIONS [71.5 KB] |
Summary of
Investigation 2
[182 KB] |
- |
|
PRECAUTIONS [93.4 KB] |
Summary of
Investigation 1
[122 KB]
(Appendix)
[1,395 KB]
Summary of
the NDB study |
- |
|
PRECAUTIONS [96.9 KB] |
Summary of
Investigation 1
[122 KB]
Summary of
Investigation 2
[182 KB]
(Appendix)
[1,395 KB]
Summary of
the NDB study |
- |
|
PRECAUTIONS [74.2 KB] |
Summary of
Investigation 2
[182 KB] |
- |
|
PRECAUTIONS [73.3 KB] |
Summary of
Investigation 2
[182 KB] |
- |
|
PRECAUTIONS [75.5 KB] |
Summary of
Investigation 1
[122 KB]
Summary of
Investigation 2
[182 KB]
(Appendix)
[1,395 KB]
Summary of
the NDB study |
- |
|
PRECAUTIONS [96.1 KB] |
Summary of
Investigation 1
[122 KB]
Summary of
Investigation 2
[182 KB]
(Appendix)
[1,395 KB]
Summary of
the NDB study |
- |
|
PRECAUTIONS [73.6 KB] |
Summary of
Investigation 2
[182 KB] |
- |
|
PRECAUTIONS [73.3 KB] |
Summary of
Investigation 2
[182 KB] |
- |
|
PRECAUTIONS [75.0 KB] |
Summary of
Investigation 1
[122 KB]
Summary of
Investigation 2
[182 KB]
(Appendix)
[1,395 KB]
Summary of
the NDB study |
- |
|
PRECAUTIONS [96.2 KB] |
Summary of
Investigation 1
[122 KB]
Summary of
Investigation 2
[182 KB]
(Appendix)
[1,395 KB]
Summary of
the NDB study |
- |
|
PRECAUTIONS [73.7 KB] |
Summary of
Investigation 2
[182 KB] |
- |
|
PRECAUTIONS [73.1 KB] |
Summary of
Investigation 2
[182 KB] |
- |
|
PRECAUTIONS [96.4 KB] |
Summary of
Investigation 1
[122 KB]
Summary of
Investigation 2
[182 KB]
(Appendix)
[1,395 KB]
Summary of
the NDB study |
- |
|
PRECAUTIONS [73.1 KB] |
Summary of
Investigation 2
[182 KB] |
- |
|
PRECAUTIONS [73.5 KB] |
Summary of
Investigation 2
[182 KB] |
- |
|
PRECAUTIONS [72.7 KB] |
Summary of
Investigation 2
[182 KB] |
- |
- Preparations containing ibuprofen (OTC drugs)
- Preparations containing naproxen (guidance-mandatory drugs)
- Preparations containing loxoprofen sodium hydrate (oral dosage form) (guidance-mandatory drugs, OTC drugs)
|
PRECAUTIONS
[70.4 KB] |
Summary of
Investigation 3
[93.2 KB] |
- |
August 27, 2024 |
|
PRECAUTIONS
[31.8 KB] |
Summary of
Investigation
[56.2 KB] |
- |
|
PRECAUTIONS
[20.3 KB] |
Summary of
Investigation
[33.1 KB]
(Appendix 1)
[225 KB]
Evaluation of the risk of kidney function test abnormal in patients with mirogabalin besilate using MID-NET)
(Appendix 2)
[216 KB]
Evaluation of the risk of kidney function test abnormal in patients with mirogabalin besilate using MID-NET |
PMDSI No.413 |
|
PRECAUTIONS
[107 KB] |
Summary of
Investigation
[148KB] |
- |
|
PRECAUTIONS
[96.9 KB] |
Summary of
Investigation
[148KB] |
- |
|
PRECAUTIONS
[15.5 KB] |
Summary of
Investigation
[148KB] |
- |
|
PRECAUTIONS
[15.8 KB] |
Summary of
Investigation
[148KB] |
- |
|
PRECAUTIONS
[13.0 KB] |
Summary of
Investigation
[31.8 KB] |
PMDSI No.413 |
|
PRECAUTIONS
[14.2 KB] |
Summary of
lnvestigation
[32.5 KB] |
PMDSI No.413 |
|
PRECAUTIONS
[13.0 KB] |
Summary of
Investigation
[31.7 KB] |
- |
- Preparations containing sulfamethoxazole sodium (OTC antibacterial ophthalmic solution)
- Preparations containing sulfamethoxazole (OTC antibacterial ophthalmic solution)
|
PRECAUTIONS
[16.1 KB] |
Summary of
Investigation
[112 KB] |
PMDSI No.413 |
July 17, 2024 |
|
PRECAUTIONS
[25.7 KB] |
Summary of
Investigation
[128 KB] |
PMDSI No.412 |
|
PRECAUTIONS
[95.2 KB] |
Summary of
Investigation
[114 KB] |
- |
|
PRECAUTIONS
[98.6 KB] |
Summary of
Investigation
[30.9 KB] |
- |
|
PRECAUTIONS
[89.8 KB] |
Summary of
Investigation
[125 KB] |
PMDSI No.412 |
|
PRECAUTIONS
[123 KB] |
Summary of
Investigation
[107 KB] |
PMDSI No.412 |
|
PRECAUTIONS
[105 KB] |
Summary of
Investigation
[115 KB] |
- |
|
PRECAUTIONS
[94.4 KB] |
Summary of
Investigation
[35.0 KB] |
PMDSI No.412 |
July 4, 2024 |
|
PRECAUTIONS
[127 KB] |
- |
- |
June 11, 2024 |
|
PRECAUTIONS
[14.5 KB] |
Summary of
Investigation
[115 KB] |
PMDSI No.411 |
|
PRECAUTIONS
[14.4 KB] |
Summary of
Investigation
[115 KB] |
- |
|
PRECAUTIONS
[17.9 KB] |
Summary of
Investigation
[121 KB] |
- |
|
PRECAUTIONS
[14.9 KB] |
Summary of
Investigation
[121 KB] |
- |
|
PRECAUTIONS
[17.5 KB] |
Summary of
Investigation
[121 KB] |
- |
|
PRECAUTIONS
[14.9 KB] |
Summary of
Investigation
[27.4 KB] |
- |
May 17,
2024 |
|
PRECAUTIONS
[34.37 KB] |
- |
- |
May 8, 2024 |
|
PRECAUTIONS [116 KB] |
Summary of
Investigation
[121 KB] |
- |
|
PRECAUTIONS [108 KB] |
Summary of
Investigation
[162 KB] |
- |
|
PRECAUTIONS [112 KB] |
Summary of
Investigation
[142 KB] |
- |
|
PRECAUTIONS [119 KB] |
Summary of
Investigation
[121 KB] |
- |
|
PRECAUTIONS [117 KB] |
Summary of
Investigation
[142 KB] |
- |
April 9, 2024 |
|
PRECAUTIONS [152 KB] |
Report on
Investigation
[248 KB]
Appendix 4 is not included in this file. See PRECAUTIONS. |
- |
|
PRECAUTIONS [153 KB] |
Report on
Investigation
[248 KB]
Appendix 4 is not included in this file. See PRECAUTIONS. |
- |
|
PRECAUTIONS [149 KB] |
Report on
Investigation
[236 KB]
Appendix 4 is not included in this file. See PRECAUTIONS. |
- |