PMDA drug package insert

ボルテゾミブ注射用3mg「DSEP」

PMDA Prescription drug · 第一三共エスファ株式会社 · package insert Sep 29, 2026

Key facts

Brand names ボルテゾミブ注射用3mg「DSEP」
Nonproprietary names ボルテゾミブ
Companies 製造販売元/第一三共エスファ株式会社, 販売提携/第一三共株式会社
Product type Prescription drug
Therapeutic category 抗悪性腫瘍剤(プロテアソーム阻害剤)
Therapeutic category codes 874291
YJ codes 4291412D1032
Approval numbers 23100AMX00223
Package insert edition 第5版
Package insert date Sep 29, 2026
PMDA document key 430773_4291412D1032_1
PMDA company code 430773

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • No PMDA review report published
  • No Risk management plan (RMP)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA approved drugs and package inserts (Japan)

Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date:

Browse all PMDA approved drugs and package inserts (Japan)