PMDA drug package insert

ボセンタン成人用DS6.25%「モチダ」

PMDA Prescription drug · 持田製薬販売株式会社 · package insert Mar 25, 2026

Key facts

Brand names ボセンタン成人用DS6.25%「モチダ」
Nonproprietary names ボセンタン水和物
Companies 製造販売元/持田製薬販売株式会社, 販売/持田製薬株式会社
Product type Prescription drug
Therapeutic category エンドセリン受容体拮抗薬
Therapeutic category codes 87219
YJ codes 2190026R1029
Approval numbers 22800AMX00572000
Package insert edition 第3版
Package insert date Mar 25, 2026
PMDA document key 790250_2190026R1029_1
PMDA company code 790250

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • No PMDA review report published
  • Yes 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)