PMDA drug package insert

コンファクトF静注用250単位

PMDA Prescription drug · KMバイオロジクス株式会社 · package insert Sep 16, 2025

Key facts

Brand names コンファクトF静注用250単位, コンファクトF静注用500単位, コンファクトF静注用1000単位
Nonproprietary names 乾燥濃縮人血液凝固第VIII因子
Companies 製造販売元/KMバイオロジクス株式会社, プロモーション提携/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 6343406X5141, 6343406X6148, 6343406X8116
Approval numbers 30400AMX00017, 30400AMX00018, 30400AMX00019
Package insert edition 第4版
Package insert date Sep 16, 2025
PMDA document key 261976_6343406X5141_1
PMDA company code 261976

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)