PMDA drug package insert

オルメサルタン錠5mg「ツルハラ」

PMDA Prescription drug · 鶴原製薬株式会社 · package insert Sep 9, 2025

Key facts

Brand names オルメサルタン錠5mg「ツルハラ」, オルメサルタン錠10mg「ツルハラ」, オルメサルタン錠20mg「ツルハラ」, オルメサルタン錠40mg「ツルハラ」
Nonproprietary names オルメサルタン メドキソミル
Companies 製造販売元/鶴原製薬株式会社
Product type Prescription drug
Therapeutic category 高親和性AT1受容体拮抗剤
Therapeutic category codes 872149
YJ codes 2149044F3124, 2149044F1113, 2149044F2110, 2149044F4120
Approval numbers 22900AMX00791000, 22900AMX00792000, 22900AMX00793000, 22900AMX00794000
Package insert edition 第2版
Package insert date Sep 9, 2025
PMDA document key 460028_2149044F1113_1
PMDA company code 460028

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)