PMDA drug package insert

テルビナフィン錠125mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Mar 25, 2024

Key facts

Brand names テルビナフィン錠125mg「サワイ」
Nonproprietary names テルビナフィン塩酸塩
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category アリルアミン系経口抗真菌剤
Therapeutic category codes 87629
YJ codes 6290005F1296
Approval numbers 22500AMX00950000
Package insert edition 第1版
Package insert date Mar 25, 2024
PMDA document key 300119_6290005F1296_1
PMDA company code 300119

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)