PMDA drug package insert

ビカルタミド錠80mg「トーワ」

PMDA Prescription drug · 東和薬品株式会社 · package insert Oct 31, 2023

Key facts

Brand names ビカルタミド錠80mg「トーワ」, ビカルタミドOD錠80mg「トーワ」
Nonproprietary names ビカルタミド
Companies 製造販売元/東和薬品株式会社
Product type Prescription drug
Therapeutic category 前立腺癌治療剤
Therapeutic category codes 874291
YJ codes 4291009F1217, 4291009F2116
Approval numbers 22200AMX00087, 22800AMX00465
Package insert edition 第1版
Package insert date Oct 31, 2023
PMDA document key 480235_4291009F1217_1
PMDA company code 480235

At a glance

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

Browse all PMDA approved drugs and package inserts (Japan)