PMDA drug package insert

プロペシア錠0.2mg

PMDA Prescription drug · オルガノン株式会社 · package insert Aug 29, 2023

Key facts

Brand names プロペシア錠0.2mg, プロペシア錠1mg
Nonproprietary names フィナステリド
Companies 製造販売元/オルガノン株式会社
Product type Prescription drug
Therapeutic category 5α-還元酵素Ⅱ型阻害薬; ◎男性型脱毛症用薬◎
Therapeutic category codes 872499
YJ codes 249900XF1021, 249900XF2028
Approval numbers 21700AMY00237000, 21700AMY00236000
Package insert edition 第4版
Package insert date Aug 29, 2023
PMDA document key 181615_249900XF1021_3
PMDA company code 181615

At a glance

  • 1–9 Package insert revisions
  • 10–99 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)