PMDA drug package insert

メトジェクト皮下注7.5mgシリンジ0.15mL

PMDA Prescription drug · 日本メダック株式会社 · package insert Mar 17, 2026

Key facts

Brand names メトジェクト皮下注7.5mgシリンジ0.15mL, メトジェクト皮下注10mgシリンジ0.20mL, メトジェクト皮下注12.5mgシリンジ0.25mL, メトジェクト皮下注15mgシリンジ0.30mL, メトジェクト皮下注7.5mgペン0.15mL, メトジェクト皮下注10mgペン0.20mL, メトジェクト皮下注12.5mgペン0.25mL, メトジェクト皮下注15mgペン0.30mL
Nonproprietary names メトトレキサート
Companies 製造販売元/日本メダック株式会社, 販売元/エーザイ株式会社
Product type Prescription drug
Therapeutic category 抗リウマチ剤
Therapeutic category codes 873999
YJ codes 3999468G1028, 3999468G2024, 3999468G3020, 3999468G4027, 3999468G5023, 3999468G6020, 3999468G7026, 3999468G8022
Approval numbers 30400AMX00426000, 30400AMX00427000, 30400AMX00428000, 30400AMX00429000, 30600AMX00100000, 30600AMX00101000, 30600AMX00099000, 30600AMX00102000
Package insert edition 第8版
Package insert date Mar 17, 2026
PMDA document key 640886_3999468G1028_1
PMDA company code 640886

At a glance

  • 1–9 Package insert revisions
  • 10–99 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)