PMDA drug package insert

ドネペジル塩酸塩OD錠3mg「FFP」

PMDA Prescription drug · 共創未来ファーマ株式会社 · package insert Aug 8, 2025

Key facts

Brand names ドネペジル塩酸塩OD錠3mg「FFP」, ドネペジル塩酸塩OD錠5mg「FFP」, ドネペジル塩酸塩OD錠10mg「FFP」
Nonproprietary names ドネペジル塩酸塩
Companies 製造販売元/共創未来ファーマ株式会社
Product type Prescription drug
Therapeutic category アルツハイマー型認知症治療剤; レビー小体型認知症治療剤
Therapeutic category codes 87119
YJ codes 1190012F3045, 1190012F4041, 1190012F6052
Approval numbers 22300AMX00887000, 22300AMX00888000, 22500AMX01444000
Package insert edition 第3版
Package insert date Aug 8, 2025
PMDA document key 300166_1190012F3045_2
PMDA company code 300166

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:

Browse all PMDA approved drugs and package inserts (Japan)