PMDA drug package insert

ニカルジピン塩酸塩錠10mg「ツルハラ」

PMDA Prescription drug · 鶴原製薬株式会社 · package insert Feb 21, 2024

Key facts

Brand names ニカルジピン塩酸塩錠10mg「ツルハラ」, ニカルジピン塩酸塩錠20mg「ツルハラ」
Nonproprietary names ニカルジピン塩酸塩
Companies 製造販売/鶴原製薬株式会社
Product type Prescription drug
Therapeutic category Ca拮抗性降圧剤
Therapeutic category codes 872149
YJ codes 2149019F1158, 2149019F2294
Approval numbers 22600AMX00582000, 22600AMX00578000
Package insert edition 第1版
Package insert date Feb 21, 2024
PMDA document key 460028_2149019F1158_1
PMDA company code 460028

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:

Browse all PMDA approved drugs and package inserts (Japan)