PMDA drug package insert

スタレボ配合錠L50

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 スタレボ配合錠L50, スタレボ配合錠L100
Nonproprietary names レボドパ・カルビドパ水和物・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 抗パーキンソン剤
Therapeutic category codes 871169
YJ codes 1169102F1027, 1169102F2023
Approval numbers 22600AMX00745000, 22600AMX00746000
Package insert edition 第4版
Package insert date Jul 28, 2026
PMDA document key 181764_1169102F1027_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)