PMDA drug package insert

ゾニサミドOD錠25mgTRE「ZE」

PMDA Prescription drug · 全星薬品工業株式会社 · package insert Jun 14, 2024

Key facts

Brand names ゾニサミドOD錠25mgTRE「ZE」, ゾニサミドOD錠50mgTRE「ZE」
Nonproprietary names ゾニサミド
Companies 製造販売元/全星薬品工業株式会社, 発売元/全星薬品株式会社
Product type Prescription drug
Therapeutic category パーキンソン病治療薬・レビー小体型認知症に伴うパーキンソニズム治療薬(レボドパ賦活剤)(OD錠25mg) パーキンソン病治療薬(レボドパ賦活剤)(OD錠50mg)
Therapeutic category codes 871169
YJ codes 1169015F2065, 1169015F3061
Approval numbers 30600AMX00071, 30600AMX00072
Package insert edition 第1版
Package insert date Jun 14, 2024
PMDA document key 380087_1169015F2065_1
PMDA company code 380087

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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