PMDA drug package insert

オンダンセトロン注4mgシリンジ「マルイシ」

PMDA Prescription drug · 丸石製薬株式会社 · package insert May 12, 2022

Key facts

Brand names オンダンセトロン注4mgシリンジ「マルイシ」
Nonproprietary names オンダンセトロン塩酸塩水和物
Companies 製造販売元/丸石製薬株式会社
Product type Prescription drug
Therapeutic category 5-HT3受容体拮抗型制吐剤
Therapeutic category codes 872391
YJ codes 2391401G1045
Approval numbers 21800AMZ10389
Package insert edition 第4版
Package insert date May 12, 2022
PMDA document key 730119_2391401G1045_2
PMDA company code 730119

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None Safety communications
  • Yes 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)