PMDA drug package insert

サイレース静注2mg

PMDA Prescription drug · エーザイ株式会社 · package insert Apr 20, 2023

Key facts

Brand names サイレース静注2mg
Nonproprietary names フルニトラゼパム
Companies 製造販売元(輸入元)/エーザイ株式会社
Product type Prescription drug
Therapeutic category 麻酔導入剤
Therapeutic category codes 871124
YJ codes 1124400A1058
Approval numbers 21900AMX00116000
Package insert edition 第1版
Package insert date Apr 20, 2023
PMDA document key 170033_1124400A1058_1
PMDA company code 170033

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)