PMDA drug package insert

ビソプロロールフマル酸塩錠0.625mg「サンド」

PMDA Prescription drug · サンド株式会社 · package insert Sep 1, 2026

Key facts

Brand names ビソプロロールフマル酸塩錠0.625mg「サンド」, ビソプロロールフマル酸塩錠2.5mg「サンド」, ビソプロロールフマル酸塩錠5mg「サンド」
Nonproprietary names ビソプロロールフマル酸塩
Companies 製造販売/サンド株式会社
Product type Prescription drug
Therapeutic category 選択的β1アンタゴニスト
Therapeutic category codes 872123
YJ codes 2123016F3126, 2123016F1182, 2123016F2260
Approval numbers 30100AMX00112000, 30100AMX00113000, 30100AMX00114000
Package insert edition 第3版
Package insert date Sep 1, 2026
PMDA document key 270428_2123016F1182_1
PMDA company code 270428

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:

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