PMDA drug package insert

トルカプ錠160mg

PMDA Prescription drug · アストラゼネカ株式会社 · package insert Mar 17, 2026

Key facts

Brand names トルカプ錠160mg, トルカプ錠200mg
Nonproprietary names カピバセルチブ
Companies 製造販売元/アストラゼネカ株式会社
Product type Prescription drug
Therapeutic category 抗悪性腫瘍剤(AKT阻害剤)
Therapeutic category codes 874291
YJ codes 4291082F1028, 4291082F2024
Approval numbers 30600AMX00119, 30600AMX00120
Package insert edition 第3版
Package insert date Mar 17, 2026
PMDA document key 670227_4291082F1028_1
PMDA company code 670227

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 Safety communications
  • Yes PMDA review report published
  • Yes 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)