PMDA drug package insert

ベポタスチンベシル酸塩錠5mg「タナベ」

PMDA Prescription drug · ニプロ株式会社 · package insert Apr 1, 2025

Key facts

Brand names ベポタスチンベシル酸塩錠5mg「タナベ」, ベポタスチンベシル酸塩錠10mg「タナベ」, ベポタスチンベシル酸塩OD錠5mg「タナベ」, ベポタスチンベシル酸塩OD錠10mg「タナベ」
Nonproprietary names ベポタスチンベシル酸塩
Companies 製造販売元/ニプロ株式会社
Product type Prescription drug
Therapeutic category 選択的ヒスタミンH1受容体拮抗・アレルギー性疾患治療剤
Therapeutic category codes 87449
YJ codes 4490022F1046, 4490022F2042, 4490022F3030, 4490022F4037
Approval numbers 22800AMX00539, 22800AMX00538, 22800AMX00537, 22800AMX00536
Package insert edition 第1版
Package insert date Apr 1, 2025
PMDA document key 530100_4490022F1046_2
PMDA company code 530100

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)