PMDA drug package insert

ベザトールSR錠100mg

PMDA Prescription drug · キッセイ薬品工業株式会社 · package insert Jun 28, 2023

Key facts

Brand names ベザトールSR錠100mg, ベザトールSR錠200mg
Nonproprietary names ベザフィブラート
Companies 製造販売元/キッセイ薬品工業株式会社
Product type Prescription drug
Therapeutic category 高脂血症治療剤
Therapeutic category codes 872183
YJ codes 2183005G2028, 2183005G1234
Approval numbers 20700AMZ00421000, 21600AMZ00267000
Package insert edition 第1版
Package insert date Jun 28, 2023
PMDA document key 230034_2183005G1234_1
PMDA company code 230034

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:

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