PMDA drug package insert

イリノテカン塩酸塩点滴静注液40mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Dec 1, 2025

Key facts

Brand names イリノテカン塩酸塩点滴静注液40mg「サワイ」, イリノテカン塩酸塩点滴静注液100mg「サワイ」
Nonproprietary names イリノテカン塩酸塩水和物
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category 抗悪性腫瘍剤
Therapeutic category codes 87424
YJ codes 4240404A1067, 4240404A2063
Approval numbers 22000AMX01765000, 22000AMX01766000
Package insert edition 第2版
Package insert date Dec 1, 2025
PMDA document key 300119_4240404A1067_1
PMDA company code 300119

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 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)