PMDA drug package insert

テモダール点滴静注用100mg

PMDA Prescription drug · 大原薬品工業株式会社 · package insert Oct 16, 2024

Key facts

Brand names テモダール点滴静注用100mg
Nonproprietary names テモゾロミド
Companies 製造販売元/大原薬品工業株式会社
Product type Prescription drug
Therapeutic category 抗悪性腫瘍剤
Therapeutic category codes 874219
YJ codes 4219404D1027
Approval numbers 22200AMX00235000
Package insert edition 第4版
Package insert date Oct 16, 2024
PMDA document key 180095_4219404D1027_2
PMDA company code 180095

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)