PMDA drug package insert

ビキセオス配合静注用

PMDA Prescription drug · 日本新薬株式会社 · package insert May 22, 2024

Key facts

Brand names ビキセオス配合静注用
Nonproprietary names ダウノルビシン塩酸塩・シタラビン
Companies 製造販売元/日本新薬株式会社
Product type Prescription drug
Therapeutic category 抗悪性腫瘍剤
Therapeutic category codes 874291
YJ codes 4291502D1029
Approval numbers 30600AMX00112000
Package insert edition 第1版
Package insert date May 22, 2024
PMDA document key 530263_4291502D1029_1
PMDA company code 530263

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes PMDA review report published
  • Yes 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)