PMDA drug package insert

オニバイド点滴静注43mg

PMDA Prescription drug · 日本セルヴィエ株式会社 · package insert Apr 1, 2026

Key facts

Brand names オニバイド点滴静注43mg
Nonproprietary names イリノテカン塩酸塩水和物
Companies 製造販売元/日本セルヴィエ株式会社
Product type Prescription drug
Therapeutic category 抗悪性腫瘍剤
Therapeutic category codes 87424
YJ codes 4240404A3027
Approval numbers 30200AMX00427000
Package insert edition 第4版
Package insert date Apr 1, 2026
PMDA document key 530457_4240404A3027_1
PMDA company code 530457

At a glance

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