PMDA drug package insert

コムタン錠100mg

PMDA Prescription drug · オリオンファーマ・ジャパン株式会社 · package insert Jul 28, 2026

Key facts

Brand names コムタン錠100mg
Nonproprietary names エンタカポン
Companies 製造販売元/オリオンファーマ・ジャパン株式会社
Product type Prescription drug
Therapeutic category 末梢COMT阻害剤
Therapeutic category codes 871169
YJ codes 1169014F1021
Approval numbers 21900AMX00048000
Package insert edition 第4版
Package insert date Jul 28, 2026
PMDA document key 181764_1169014F1021_2
PMDA company code 181764

At a glance

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