PMDA drug package insert

フィナステリド錠0.2mg「RTO」

PMDA Prescription drug · リョートーファイン株式会社 · package insert Aug 29, 2023

Key facts

Brand names フィナステリド錠0.2mg「RTO」, フィナステリド錠1mg「RTO」
Nonproprietary names フィナステリド
Companies 製造販売元/リョートーファイン株式会社, 販売元/江州製薬株式会社
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 249900XF1102, 249900XF2109
Approval numbers 22900AMX00944000, 22900AMX00945000
Package insert edition 第1版
Package insert date Aug 29, 2023
PMDA document key 850079_249900XF1102_1
PMDA company code 850079

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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