PMDA drug package insert

レボセチリジン塩酸塩錠5mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Dec 16, 2025

Key facts

Brand names レボセチリジン塩酸塩錠5mg「サワイ」, レボセチリジン塩酸塩OD錠5mg「サワイ」
Nonproprietary names レボセチリジン塩酸塩
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category 持続性選択H1受容体拮抗・アレルギー性疾患治療剤
Therapeutic category codes 87449
YJ codes 4490028F1116, 4490028F4042
Approval numbers 30200AMX00108000, 30200AMX00159000
Package insert edition 第2版
Package insert date Dec 16, 2025
PMDA document key 300119_4490028F1116_1
PMDA company code 300119

At a glance

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