PMDA drug package insert

ヒスロン錠5

PMDA Prescription drug · 協和キリン株式会社 · package insert Dec 17, 2024

Key facts

Brand names ヒスロン錠5
Nonproprietary names メドロキシプロゲステロン酢酸エステル
Companies 製造販売元/協和キリン株式会社
Product type Prescription drug
Therapeutic category 経口黄体ホルモン製剤
Therapeutic category codes 872478
YJ codes 2478002F2033
Approval numbers 14000AZY00535
Package insert edition 第4版
Package insert date Dec 17, 2024
PMDA document key 230124_2478002F2033_1
PMDA company code 230124

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None 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)