SmPC - Midazolam 2 mg/ml solution for injection or infusion: Change history
View Summary of Product Characteristics (SmPC - Midazolam 2 mg/ml solution for injection or infusion)
Last updated on this site: 27 Jun 2024
SmPC sections 4.2, 4.4, 4.5, 4.6 (5mg only), 4.8, 4.9 (5mg only), 5.1, 5.2 and the PIL have been updated in-line with information from the reference product (Hypnovel 2mg/ml, 5mg/ml Solution for Injection; DCP/MRP number: DE/H/3599/002; MAH: Cheplapharm Arzneimittel GmbH, Germany).
Last updated on this site: 27 Jun 2024
SmPC sections 4.2, 4.4, 4.5, 4.6 (5mg only), 4.8, 4.9 (5mg only), 5.1, 5.2 and the PIL have been updated in-line with information from the reference product (Hypnovel 2mg/ml, 5mg/ml Solution for Injection; DCP/MRP number: DE/H/3599/002; MAH: Cheplapharm Arzneimittel GmbH, Germany).
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Changes: (Updated: 27 Jun 2024)
SmPC sections 4.2, 4.4, 4.5, 4.6 (5mg only), 4.8, 4.9 (5mg only), 5.1, 5.2 and the PIL have been updated in-line with information from the reference product (Hypnovel 2mg/ml, 5mg/ml Solution for Injection; DCP/MRP number: DE/H/3599/002; MAH: Cheplapharm Arzneimittel GmbH, Germany).
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Changes: (Updated: 06 Sep 2023)
Description of update: To submit Type IAIN (C.1.3.a) variation to update SmPC section 4.8 and leaflet section 4 to add Kounis syndrome with a frequency not known to implement the wording agreed by the PRAC following the outcome of the PSUSA procedure (PSUSA/00002057/202209) for Midazolam 2 mg/ml/5mg/ml Solution for Injection or Infusion.
SmPC sections updated: 4.8, 10.
PIL sections updated: 4, 6.
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Changes: (Updated: 07 Jun 2023)
Website administration update - no change to document content
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Changes: (Updated: 21 Sep 2022)
Initial upload