PMDA drug package insert

ヒルトニン1mg注射液

PMDA Prescription drug · T's製薬株式会社 · package insert Sep 1, 2025

Key facts

Brand names ヒルトニン1mg注射液, ヒルトニン2mg注射液
Nonproprietary names プロチレリン酒石酸塩水和物
Companies 製造販売元/T's製薬株式会社, 販売/武田薬品工業株式会社
Product type Prescription drug
Therapeutic category 遷延性意識障害治療剤; 脊髄小脳変性症治療剤
Therapeutic category codes 87119
YJ codes 7223401A2020, 7223401A3026
Approval numbers 15800AMZ00495, 15800AMZ00496
Package insert edition 第2版
Package insert date Sep 1, 2025
PMDA document key 400061_7223401A2020_2
PMDA company code 400061

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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