PMDA drug package insert

ベニジピン塩酸塩錠2mg「OME」

PMDA Prescription drug · 大原薬品工業株式会社 · package insert Sep 26, 2023

Key facts

Brand names ベニジピン塩酸塩錠2mg「OME」, ベニジピン塩酸塩錠4mg「OME」, ベニジピン塩酸塩錠8mg「OME」
Nonproprietary names ベニジピン塩酸塩
Companies 製造販売元/大原薬品工業株式会社
Product type Prescription drug
Therapeutic category 高血圧症・狭心症治療剤(持続性Ca拮抗薬)
Therapeutic category codes 872179
YJ codes 2171021F1075, 2171021F2110, 2171021F3124
Approval numbers 21800AMZ10317000, 21800AMZ10318000, 22000AMX01197000
Package insert edition 第1版
Package insert date Sep 26, 2023
PMDA document key 180095_2171021F1075_1
PMDA company code 180095

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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