PMDA drug package insert

テモゾロミド錠20mg「NK」

PMDA Prescription drug · 日本化薬株式会社 · package insert Oct 16, 2024

Key facts

Brand names テモゾロミド錠20mg「NK」, テモゾロミド錠100mg「NK」
Nonproprietary names テモゾロミド
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 874219
YJ codes 4219004F1025, 4219004F2021
Approval numbers 22900AMX00866, 22900AMX00865
Package insert edition 第3版
Package insert date Oct 16, 2024
PMDA document key 530191_4219004F1025_1
PMDA company code 530191

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)