PMDA drug package insert

オークル錠100mg

PMDA Prescription drug · 日本新薬株式会社 · package insert Jul 28, 2022

Key facts

Brand names オークル錠100mg
Nonproprietary names アクタリット
Companies 製造販売元/日本新薬株式会社
Product type Prescription drug
Therapeutic category 抗リウマチ剤
Therapeutic category codes 871149
YJ codes 1149031F1030
Approval numbers 20600AMZ00930000
Package insert edition 第1版
Package insert date Jul 28, 2022
PMDA document key 530263_1149031F1030_1
PMDA company code 530263

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)