PMDA drug package insert

ビカルタミド錠80mg「日医工」(旧製品)

PMDA Prescription drug · 日医工株式会社 · package insert Jul 24, 2026

Key facts

Brand names ビカルタミド錠80mg「日医工」(旧製品), ビカルタミドOD錠80mg「日医工」
Nonproprietary names ビカルタミド
Companies 製造販売元/日医工株式会社
Product type Prescription drug
Therapeutic category 前立腺癌治療剤
Therapeutic category codes 874291
YJ codes 4291009F1160, 4291009F2086
Approval numbers 22100AMX00117000, 22800AMX00259000
Package insert edition 第3版
Package insert date Jul 24, 2026
PMDA document key 530169_4291009F1160_1
PMDA company code 530169

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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