PMDA drug package insert

ユバンシ配合錠

PMDA Prescription drug · ヤンセンファーマ株式会社 · package insert Mar 17, 2026

Key facts

Brand names ユバンシ配合錠
Nonproprietary names マシテンタン・タダラフィル
Companies 製造販売元(輸入)/ヤンセンファーマ株式会社, 販売提携先/日本新薬株式会社
Product type Prescription drug
Therapeutic category エンドセリン受容体拮抗薬/ホスホジエステラーゼ5阻害剤
Therapeutic category codes 87219
YJ codes 2190105F1029
Approval numbers 30600AMX00252000
Package insert edition 第3版
Package insert date Mar 17, 2026
PMDA document key 800155_2190105F1029_1
PMDA company code 800155

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes 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)