PMDA drug package insert

オンダンセトロンODフィルム4mg「GFP」

PMDA Prescription drug · ミヤリサン製薬株式会社 · package insert Jun 19, 2023

Key facts

Brand names オンダンセトロンODフィルム4mg「GFP」, オンダンセトロンODフィルム2mg「GFP」
Nonproprietary names オンダンセトロン塩酸塩水和物
Companies 製造販売元/ミヤリサン製薬株式会社
Product type Prescription drug
Therapeutic category 5-HT3受容体拮抗型制吐剤
Therapeutic category codes 872391
YJ codes 2391001F4020, 2391001F3023
Approval numbers 22900AMX00812000, 22900AMX00811000
Package insert edition 第2版
Package insert date Jun 19, 2023
PMDA document key 750144_2391001F3023_3
PMDA company code 750144

At a glance

  • 1–9 Package insert revisions
  • 1–9 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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