PMDA drug package insert

ロサルタンK錠25mg「オーハラ」

PMDA Prescription drug · 大原薬品工業株式会社 · package insert Sep 9, 2025

Key facts

Brand names ロサルタンK錠25mg「オーハラ」, ロサルタンK錠50mg「オーハラ」, ロサルタンK錠100mg「オーハラ」
Nonproprietary names ロサルタンカリウム
Companies 製造販売元/大原薬品工業株式会社
Product type Prescription drug
Therapeutic category A–Ⅱアンタゴニスト
Therapeutic category codes 872149
YJ codes 2149039F1074, 2149039F2070, 2149039F3069
Approval numbers 22400AMX00478000, 22400AMX00479000, 22400AMX00480000
Package insert edition 第2版
Package insert date Sep 9, 2025
PMDA document key 180095_2149039F1074_1
PMDA company code 180095

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 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)