PMDA drug package insert

クロスエイトMC静注用2000単位

PMDA Prescription drug · 一般社団法人 日本血液製剤機構 · package insert Sep 16, 2025

Key facts

Brand names クロスエイトMC静注用2000単位, クロスエイトMC静注用3000単位
Nonproprietary names 乾燥濃縮人血液凝固第VIII因子
Companies 製造販売元/一般社団法人 日本血液製剤機構
Product type Prescription drug
Therapeutic category 血漿分画製剤
Therapeutic category codes 876343
YJ codes 6343406X9023, 6343406Y1028
Approval numbers 22700AMX00721, 30200AMX00958
Package insert edition 第4版
Package insert date Sep 16, 2025
PMDA document key 580842_6343406X9023_1
PMDA company code 580842

At a glance

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