PMDA drug package insert

インライタ錠1mg

PMDA Prescription drug · ファイザー株式会社 · package insert Feb 10, 2026

Key facts

Brand names インライタ錠1mg, インライタ錠5mg
Nonproprietary names アキシチニブ
Companies 製造販売元(輸入)/ファイザー株式会社
Product type Prescription drug
Therapeutic category 抗悪性腫瘍剤/キナーゼ阻害剤
Therapeutic category codes 874291
YJ codes 4291027F1029, 4291027F2025
Approval numbers 22400AMX00737, 22400AMX00738
Package insert edition 第4版
Package insert date Feb 10, 2026
PMDA document key 672212_4291027F1029_2
PMDA company code 672212

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)