PMDA drug package insert

ドンペリドン錠5mg「ツルハラ」

PMDA Prescription drug · 鶴原製薬株式会社 · package insert Aug 25, 2026

Key facts

Brand names ドンペリドン錠5mg「ツルハラ」, ドンペリドン錠10mg「ツルハラ」
Nonproprietary names ドンペリドン
Companies 製造販売元/鶴原製薬株式会社
Product type Prescription drug
Therapeutic category 消化管運動改善剤
Therapeutic category codes 872399
YJ codes 2399005F1256, 2399005F2376
Approval numbers 22600AMX00087000, 22600AMX00086000
Package insert edition 第3版
Package insert date Aug 25, 2026
PMDA document key 460028_2399005F1256_1
PMDA company code 460028

At a glance

  • 1–9 Package insert revisions
  • 10–99 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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