PMDA drug package insert

ガランタミンOD錠4mg「ニプロ」

PMDA Prescription drug · ニプロ株式会社 · package insert Apr 25, 2024

Key facts

Brand names ガランタミンOD錠4mg「ニプロ」, ガランタミンOD錠8mg「ニプロ」, ガランタミンOD錠12mg「ニプロ」
Nonproprietary names ガランタミン臭化水素酸塩
Companies 製造販売元/ニプロ株式会社
Product type Prescription drug
Therapeutic category アルツハイマー型認知症治療剤
Therapeutic category codes 87119
YJ codes 1190019F4116, 1190019F5112, 1190019F6119
Approval numbers 30200AMX00066, 30200AMX00067, 30200AMX00068
Package insert edition 第3版
Package insert date Apr 25, 2024
PMDA document key 530100_1190019F4116_1
PMDA company code 530100

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)