PMDA drug package insert

ベシケア錠2.5mg

PMDA Prescription drug · アステラス製薬株式会社 · package insert Dec 7, 2020

Key facts

Brand names ベシケア錠2.5mg, ベシケア錠5mg
Nonproprietary names コハク酸ソリフェナシン
Companies 製造販売/アステラス製薬株式会社
Product type Prescription drug
Therapeutic category 過活動膀胱治療剤
Therapeutic category codes 87259
YJ codes 2590011F1028, 2590011F2024
Approval numbers 21800AMZ10357, 21800AMZ10358
Package insert edition 第2版
Package insert date Dec 7, 2020
PMDA document key 800126_2590011F1028_1
PMDA company code 800126

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:

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