PMDA drug package insert

ハイカムチン点滴静注液1mg/1mL

PMDA Prescription drug · 日本化薬株式会社 · package insert Feb 2, 2026

Key facts

Brand names ハイカムチン点滴静注液1mg/1mL
Nonproprietary names ノギテカン塩酸塩
Companies 製造販売元/日本化薬株式会社
Product type Prescription drug
Therapeutic category 抗悪性腫瘍剤
Therapeutic category codes 87424
YJ codes 4240408A1022
Approval numbers 30700AMX00197
Package insert edition 第1版
Package insert date Feb 2, 2026
PMDA document key 530191_4240408A1022_1
PMDA company code 530191

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)