PMDA drug package insert

モサプリドクエン酸塩錠2.5mg「DSEP」

PMDA Prescription drug · 第一三共エスファ株式会社 · package insert May 17, 2024

Key facts

Brand names モサプリドクエン酸塩錠2.5mg「DSEP」, モサプリドクエン酸塩錠5mg「DSEP」
Nonproprietary names モサプリドクエン酸塩水和物
Companies 製造販売元/第一三共エスファ株式会社, 販売提携/第一三共株式会社
Product type Prescription drug
Therapeutic category 消化管運動機能改善剤
Therapeutic category codes 872399
YJ codes 2399010F1052, 2399010F2059
Approval numbers 22400AMX01137, 22400AMX01138
Package insert edition 第1版
Package insert date May 17, 2024
PMDA document key 430773_2399010F1052_1
PMDA company code 430773

At a glance

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

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