PMDA drug package insert

フィナステリド錠0.2mg「FCI」

PMDA Prescription drug · 富士化学工業株式会社 · package insert Apr 22, 2026

Key facts

Brand names フィナステリド錠0.2mg「FCI」, フィナステリド錠1mg「FCI」
Nonproprietary names フィナステリド
Companies 製造販売元/富士化学工業株式会社
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 249900XF1110, 249900XF2117
Approval numbers 23000AMX00075000, 23000AMX00074000
Package insert edition 第2版
Package insert date Apr 22, 2026
PMDA document key 670082_249900XF1110_1
PMDA company code 670082

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:

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