PMDA drug package insert

ベバシズマブBS点滴静注100mg「アムジェン」

PMDA Prescription drug · アムジェン株式会社 · package insert Jul 16, 2025

Key facts

Brand names ベバシズマブBS点滴静注100mg「アムジェン」, ベバシズマブBS点滴静注400mg「アムジェン」
Nonproprietary names ベバシズマブ(遺伝子組換え)
Companies 製造販売元/アムジェン株式会社
Product type Prescription drug
Therapeutic category 抗悪性腫瘍剤/抗VEGFヒト化モノクローナル抗体; VEGF:Vascular Endothelial Growth Factor(血管内皮増殖因子)
Therapeutic category codes 874291
YJ codes 4291450A1031, 4291450A2038
Approval numbers 30100AMX00289000, 30100AMX00290000
Package insert edition 第1版
Package insert date Jul 16, 2025
PMDA document key 112292_4291450A1031_1
PMDA company code 112292

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • No 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)