PMDA drug package insert

エルデカルシトールカプセル0.5μg「日医工」

PMDA Prescription drug · 日医工株式会社 · package insert Feb 15, 2024

Key facts

Brand names エルデカルシトールカプセル0.5μg「日医工」, エルデカルシトールカプセル0.75μg「日医工」
Nonproprietary names エルデカルシトール
Companies 製造販売元/日医工株式会社
Product type Prescription drug
Therapeutic category 骨粗鬆症治療剤(活性型ビタミンD3製剤)
Therapeutic category codes 873112
YJ codes 3112006M1049, 3112006M2045
Approval numbers 30200AMX00381000, 30200AMX00382000
Package insert edition 第2版
Package insert date Feb 15, 2024
PMDA document key 530169_3112006M1049_1
PMDA company code 530169

At a glance

  • 1–9 Package insert revisions
  • 1–9 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:

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