PMDA drug package insert

イトリゾールカプセル50

PMDA Prescription drug · ヤンセンファーマ株式会社 · package insert Aug 28, 2026

Key facts

Brand names イトリゾールカプセル50
Nonproprietary names イトラコナゾール
Companies 製造販売元(輸入)/ヤンセンファーマ株式会社
Product type Prescription drug
Therapeutic category 経口抗真菌剤
Therapeutic category codes 87629
YJ codes 6290004M1029
Approval numbers 20500AMY00202000
Package insert edition 第8版
Package insert date Aug 28, 2026
PMDA document key 800155_6290004M1029_1
PMDA company code 800155

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)