PMDA drug package insert

PPSB−HT静注用200単位「タケダ」

PMDA Prescription drug · 武田薬品工業株式会社 · package insert Sep 9, 2025

Key facts

Brand names PPSB−HT静注用200単位「タケダ」, PPSB−HT静注用500単位「タケダ」
Nonproprietary names 乾燥人血液凝固第IX因子複合体
Companies 製造販売元/武田薬品工業株式会社
Product type Prescription drug
Therapeutic category 血漿分画製剤(血液凝固因子製剤)
Therapeutic category codes 876343
YJ codes 6343409X5048, 6343409X7067
Approval numbers 22100AMX01058, 22100AMX01059
Package insert edition 第2版
Package insert date Sep 9, 2025
PMDA document key 400256_6343409X5048_1
PMDA company code 400256

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:

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