PMDA drug package insert

ハルシオン0.125mg錠

PMDA Prescription drug · ファイザー株式会社 · package insert Jul 14, 2026

Key facts

Brand names ハルシオン0.125mg錠, ハルシオン0.25mg錠
Nonproprietary names トリアゾラム
Companies 製造販売元/ファイザー株式会社
Product type Prescription drug
Therapeutic category 睡眠導入剤
Therapeutic category codes 871124
YJ codes 1124007F1020, 1124007F2026
Approval numbers 20100AMZ00434, 15700AMZ01290
Package insert edition 第7版
Package insert date Jul 14, 2026
PMDA document key 672212_1124007F1020_4
PMDA company code 672212

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 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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