PMDA drug package insert

ゼポジアカプセルスターターパック

PMDA Prescription drug · ブリストル・マイヤーズ スクイブ株式会社 · package insert Apr 1, 2026

Key facts

Brand names ゼポジアカプセルスターターパック, ゼポジアカプセル0.92mg
Nonproprietary names オザニモド塩酸塩
Companies 製造販売元/ブリストル・マイヤーズ スクイブ株式会社
Product type Prescription drug
Therapeutic category 潰瘍性大腸炎治療剤/スフィンゴシン1-リン酸(S1P)受容体調節剤
Therapeutic category codes 872399
YJ codes 2399019X1024, 2399019M1028
Approval numbers 30600AMX00296000, 30600AMX00295000
Package insert edition 第3版
Package insert date Apr 1, 2026
PMDA document key 670605_2399019M1028_1
PMDA company code 670605

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes PMDA review report published
  • Yes 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)