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Post-marketing Safety Measures

Revisions of PRECAUTIONS (FY2024)

Posted 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)
July 4, 2024 Freeze-dried smallpox vaccine prepared in cell culture PRECAUTIONS
[127 KB]
 
June 11, 2024 Brimonidine tartrate PRECAUTIONS
[14.5 KB]
Summary of
Investigation
[115 KB]
 
Brimonidine tartrate/
brinzolamide
 
Ripasudil
hydrochloride hydrate/
brimonidine tartrate
 
Brimonidine tartrate/
timolol maleate
PRECAUTIONS
[14.4 KB]
 
Finerenone PRECAUTIONS
[17.9 KB]
Summary of
Investigation
[121 KB]
 
Posaconazole PRECAUTIONS
[14.9 KB]
 
Posaconazole  
Voriconazole PRECAUTIONS
[17.5 KB]
 
Voriconazole  
Carglumic acid PRECAUTIONS
[14.9 KB]
Summary of
Investigation
[27.4 KB]
 
May 17,
2024
Pembrolizumab
(genetical
recombination)
PRECAUTIONS
[34.37 KB]
 

May 8, 2024

Rivaroxaban

PRECAUTIONS [116 KB]

Summary of
Investigation
[121 KB]

 

Colistin sodium
methanesulfonate
(injections)

PRECAUTIONS [108 KB]

Summary of
Investigation
[162 KB]

 

Amoxicillin hydrate

PRECAUTIONS [112 KB]

Summary of
Investigation
[142 KB]

 

Potassium
clavulanate/
amoxicillin hydrate

 

Posaconazole

PRECAUTIONS [119 KB]

Summary of
Investigation
[121 KB]

 

Posaconazole

 

Vonoprazan fumarate/
amoxicillin hydrate/
clarithromycin

PRECAUTIONS [117 KB]

Summary of
Investigation
[142 KB]

 

Vonoprazan fumarate/
amoxicillin hydrate/
metronidazole

 

Rabeprazole sodium/
amoxicillin hydrate/
clarithromycin

 

Rabeprazole sodium/
amoxicillin hydrate/
metronidazole

 
April 9, 2024 Bisoprolol fumarate PRECAUTIONS [152 KB] Report on
Investigation
[248 KB]
Appendix 4 is not included in this file. See PRECAUTIONS.
 
Bisoprolol PRECAUTIONS [153 KB]  
Carvedilol PRECAUTIONS [149 KB] Report on
Investigation
[236 KB]
Appendix 4 is not included in this file. See PRECAUTIONS.