PMDA drug package insert

ベリナート皮下注用2000

PMDA Prescription drug · CSLベーリング株式会社 · package insert Mar 15, 2024

Key facts

Brand names ベリナート皮下注用2000
Nonproprietary names 乾燥濃縮人C1-インアクチベーター
Companies 製造販売(輸入)/CSLベーリング株式会社
Product type Prescription drug
Therapeutic category 血漿分画製剤
Therapeutic category codes 876343
YJ codes 6343426D1023
Approval numbers 30400AMX00436
Package insert edition 第5版
Package insert date Mar 15, 2024
PMDA document key 100806_6343426D1023_1
PMDA company code 100806

At a glance

  • 1–9 Package insert revisions
  • 1–9 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)