PMDA drug package insert

レバチオ錠20mg

PMDA Prescription drug · ヴィアトリス製薬合同会社 · package insert Feb 19, 2026

Key facts

Brand names レバチオ錠20mg, レバチオODフィルム20mg, レバチオ懸濁用ドライシロップ900mg
Nonproprietary names シルデナフィルクエン酸塩
Companies 製造販売元/ヴィアトリス製薬合同会社
Product type Prescription drug
Therapeutic category ホスホジエステラーゼ5阻害薬
Therapeutic category codes 87219
YJ codes 2190028F1021, 2190028F2028, 2190028R1028
Approval numbers 22000AMX00022, 22900AMX00974, 22900AMX00972
Package insert edition 第9版
Package insert date Feb 19, 2026
PMDA document key 671450_2190028F1021_4
PMDA company code 671450

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)