PMDA drug package insert

ドネペジル塩酸塩錠3mg「オーハラ」

PMDA Prescription drug · 大原薬品工業株式会社 · package insert Sep 9, 2024

Key facts

Brand names ドネペジル塩酸塩錠3mg「オーハラ」, ドネペジル塩酸塩錠5mg「オーハラ」, ドネペジル塩酸塩錠10mg「オーハラ」
Nonproprietary names ドネペジル塩酸塩
Companies 製造販売元/大原薬品工業株式会社
Product type Prescription drug
Therapeutic category アルツハイマー型、レビー小体型認知症治療剤
Therapeutic category codes 87119
YJ codes 1190012F1131, 1190012F2138, 1190012F5153
Approval numbers 22300AMX00949000, 22300AMX00947000, 22500AMX01448000
Package insert edition 第3版
Package insert date Sep 9, 2024
PMDA document key 180095_1190012F1131_1
PMDA company code 180095

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)