PMDA drug package insert

デュファストン錠5mg

PMDA Prescription drug · ヴィアトリス製薬合同会社 · package insert Jan 1, 2025

Key facts

Brand names デュファストン錠5mg
Nonproprietary names ジドロゲステロン
Companies 製造販売元/ヴィアトリス製薬合同会社
Product type Prescription drug
Therapeutic category レトロ・プロゲステロン製剤
Therapeutic category codes 872478
YJ codes 2478003F1031
Approval numbers 22000AMX02234
Package insert edition 第8版
Package insert date Jan 1, 2025
PMDA document key 671450_2478003F1031_4
PMDA company code 671450

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • 1–9 Safety communications
  • Yes 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)