Pharmaceuticals and Medical Devices Agency (Japan) pmda.go.jp

[ANZEN]Revisions of PRECAUTIONS: Cladribine posted

Imported from official source

October 02, 2026 03:00 Announcement

Pembrolizumab
(genetical recombination)

Tocilizumab
(genetical recombination)
[Tocilizumab biosimilar1]

Tocilizumab
(genetical recombination)
[Tocilizumab biosimilar2]

Isopropylantipyrine/acetaminophen/
allylisopropylacetylurea/
anhydrous caffeine

Salicylamide/acetaminophen/
anhydrous caffeine/
chlorpheniramine maleate

Salicylamide/acetaminophen/
anhydrous caffeine/
promethazine methylenedisalicylate

Diprophylline/
dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
diphenhydramine salicylate/
acetaminophen/bromovalerylurea

Elvitegravir/cobicistat/emtricitabine/
tenofovir alafenamide fumarate

Darunavir ethanolate/cobicistat/
emtricitabine/
tenofovir alafenamide fumarate

Dolutegravir sodium/
rilpivirine hydrochloride

Bictegravir sodium/emtricitabine/
tenofovir alafenamide fumarate

Rilpivirine hydrochloride/emtricitabine/
tenofovir alafenamide fumarate

OTC drugs containing Kakkonto formulation

Freeze-dried Bacillus Calmette-Guérin (BCG) for intravesical use
(Japanese strain)

Insulin aspart
(genetical recombination)
(Fiasp Injection 100U/mL)

Doxorubicin hydrochloride
(liposome formulations)

Vonoprazan Fumarate/
Amoxicillin Hydrate/Clarithromycin

Vonoprazan Fumarate/
Amoxicillin Hydrate/Metronidazole

Anti-human thymocyte immunoglobulin, rabbit

Preparations containing omeprazole
(guidance-mandatory drugs)

Preparations containing rabeprazole sodium
(guidance-mandatory drugs)

Preparations containing lansoprazole
(guidance-mandatorydrugs)

Sulfamethoxazole/trimethoprim
(oral dosage form)

Sulfamethoxazole/trimethoprim (injection)

Infliximab
(genetical recombination) and biosimilars

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Organization: Pharmaceuticals and Medical Devices Agency (Japan) — imported from official source
Official source: https://www.pmda.go.jp/rss_008.xml RSS
Imported: October 03, 2026 20:39
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Identity: https://www.pmda.go.jp/english/safety/info-services/drugs/revision-of-precautions/0014....