PMDA drug package insert

シロドシンOD錠2mg「Me」

PMDA Prescription drug · Meファルマ株式会社 · package insert Oct 14, 2022

Key facts

Brand names シロドシンOD錠2mg「Me」, シロドシンOD錠4mg「Me」
Nonproprietary names シロドシン
Companies 製造販売元/Meファルマ株式会社, 販売提携/Meiji Seika ファルマ株式会社
Product type Prescription drug
Therapeutic category 選択的α1A遮断薬; 前立腺肥大症に伴う排尿障害改善薬
Therapeutic category codes 87259
YJ codes 2590010F3077, 2590010F4073
Approval numbers 23100AMX00198000, 23100AMX00199000
Package insert edition 第1版
Package insert date Oct 14, 2022
PMDA document key 171950_2590010F3077_1
PMDA company code 171950

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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