PMDA drug package insert

ハラヴェン静注1mg

PMDA Prescription drug · エーザイ株式会社 · package insert Jan 24, 2022

Key facts

Brand names ハラヴェン静注1mg
Nonproprietary names エリブリンメシル酸塩
Companies 製造販売元(輸入元)/エーザイ株式会社
Product type Prescription drug
Therapeutic category 抗悪性腫瘍剤
Therapeutic category codes 874291
YJ codes 4291420A1022
Approval numbers 22300AMX00520000
Package insert edition 第1版
Package insert date Jan 24, 2022
PMDA document key 170033_4291420A1022_1
PMDA company code 170033

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)