PMDA drug package insert

ダサチニブ錠20mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Oct 22, 2025

Key facts

Brand names ダサチニブ錠20mg「サワイ」, ダサチニブ錠50mg「サワイ」
Nonproprietary names ダサチニブ
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; チロシンキナーゼインヒビター
Therapeutic category codes 874291
YJ codes 4291020F1051, 4291020F2058
Approval numbers 30400AMX00109000, 30400AMX00110000
Package insert edition 第3版
Package insert date Oct 22, 2025
PMDA document key 300119_4291020F1051_1
PMDA company code 300119

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)