Italian Medicines Agency Agenzia Italiana del Farmaco

Direct communication with healthcare professionals on Norditropin NordiFlex® (somatropin, hormone of human growth) - Direct communication with healthcare professionals on Norditropin NordiFlex® (somatropin, hormone of human growth)

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Direct communication with healthcare professionals on Norditropin NordiFlex® (somatropin, hormone of human growth)

The Italian Medicines Agency, intends to provide an update on the medicinal product Norditropin NordiFlex®. As of April 2023, a shortage of Norditropin Nordiflex® 15mg/1.5ml solution for injection (AIC 027686118) has been declared, as per the information note published on the AIFA website on 6 February 2023. We hereby inform you that the marketing of the medicinal product, in all authorized packaging, will be definitively discontinued.

Specifically:

  • Norditropin NordiFlex 15 mg/1.5 ml, solution for injection in pre-filled pen (AIC 027686118): definitively discontinued on the market starting from 22/02/2024.
  • Norditropin NordiFlex 5 mg/1.5 ml, solution for injection in pre-filled pen (AIC 027686094): in quota distribution presumably until 15/04/2024; subsequently, periods of total shortage and quota distribution will alternate until the definitive marketing cessation, during 2025.

For any updates, please refer to the Lists of Medicines in Shortage, which are periodically updated and published at the following link.

It should be noted that the marketing cessations in question are not related to any defect in the quality of the medicinal products or to safety concerns.


Published on: 27 March 2024

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