PMDA drug package insert

イマチニブ錠100mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Jan 17, 2023

Key facts

Brand names イマチニブ錠100mg「サワイ」, イマチニブ錠200mg「サワイ」
Nonproprietary names イマチニブメシル酸塩
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 4291011F1133, 4291011F2075
Approval numbers 22600AMX00937000, 22700AMX00850000
Package insert edition 第4版
Package insert date Jan 17, 2023
PMDA document key 300119_4291011F1133_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)