PMDA drug package insert

アルファカルシドール錠0.25μg「アメル」

PMDA Prescription drug · 共和薬品工業株式会社 · package insert Feb 15, 2024

Key facts

Brand names アルファカルシドール錠0.25μg「アメル」, アルファカルシドール錠0.5μg「アメル」, アルファカルシドール錠1.0μg「アメル」
Nonproprietary names アルファカルシドール
Companies 製造販売元/共和薬品工業株式会社
Product type Prescription drug
Therapeutic category 活性型ビタミンD3製剤
Therapeutic category codes 873112
YJ codes 3112001F1063, 3112001F2060, 3112001F3066
Approval numbers 30100AMX00033, 30100AMX00034, 30100AMX00035
Package insert edition 第2版
Package insert date Feb 15, 2024
PMDA document key 672173_3112001F1063_2
PMDA company code 672173

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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