PMDA drug package insert

アキャルックス点滴静注250mg

PMDA Prescription drug · 楽天メディカル株式会社 · package insert Oct 9, 2024

Key facts

Brand names アキャルックス点滴静注250mg
Nonproprietary names セツキシマブ サロタロカンナトリウム(遺伝子組換え)
Companies 製造発売元/楽天メディカル株式会社
Product type Prescription drug
Therapeutic category 抗体-光感受性物質複合体
Therapeutic category codes 874299
YJ codes 4299406A1020
Approval numbers 30200AMX00942000
Package insert edition 第8版
Package insert date Oct 9, 2024
PMDA document key 841001_4299406A1020_1
PMDA company code 841001

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None 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)