PMDA drug package insert

デュタステリド錠0.1mgZA「NS」

PMDA Prescription drug · 日新製薬株式会社 · package insert Dec 22, 2023

Key facts

Brand names デュタステリド錠0.1mgZA「NS」, デュタステリド錠0.5mgZA「NS」
Nonproprietary names デュタステリド
Companies 製造販売元/日新製薬株式会社
Product type Prescription drug
Therapeutic category 5α還元酵素1型/2型阻害薬 男性型脱毛症治療薬
Therapeutic category codes 87249
YJ codes 249900AF1024, 249900AF2020
Approval numbers 30300AMX00463, 30300AMX00462
Package insert edition 第1版
Package insert date Dec 22, 2023
PMDA document key 530113_249900AF1024_1
PMDA company code 530113

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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