Norditropin NordiFlex - supply shortage
Ongoing
somatropin
ShortageHuman
Shortage information
Norditropin NordiFlex contains somatropin, a copy of naturally occurring human growth hormone. They are used to promote growth in people with growth hormone deficiency and those with certain growth problems.
This page was first modified on 28 October 2024 to reflect the marketing cessation of Norditropin NordiFlex by the company, and then on 17 December 2024 as the supply of Norditropin FlexPro had resolved.
The supply shortage was initially due to a slower than anticipated ramp up of the manufacturing facility.
The company has since decided to stop marketing Norditropin NordiFlex in the EU/EEA; this will come into effect from the end of 2024 onwards, but timelines may vary from country to country.
There were also intermittent shortages of Norditropin FlexPro, 5 mg pre-filled pen which have now been resolved.
The supply shortage is not related to a quality defect of the product or a safety issue.
Since late 2022, all EU Member States have experienced shortages of Norditropin NordiFlex. The company has now decided to stop marketing the medicine, which means that it will no longer be produced and therefore no longer be available. The discontinuation will come into effect from the end of 2024 onwards, but timelines may vary from country to country.
For up-to-date information about the status of a medicine shortage in a particular Member State, contact the national competent authority.
EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party) is closely monitoring the supply situation and engaging with the marketing authorisation holder to identify measures to mitigate the impact of the supply shortage.
The SPOC working party is responsible for monitoring and reporting events that could affect the supply of medicines in the EU.
- The company marketing Norditropin products has decided to stop marketing Norditropin NordiFlex; this will come into effect from the end of 2024 onwards, but timelines may vary from country to country. Treatment alternatives are available.
- Healthcare professionals should switch patients using Norditropin NordiFlex to a suitable alternative.
- Additional advice may be available from your country’s national shortage register or national competent authority.
- The company marketing Norditropin products has decided to stop marketing Norditropin NordiFlex; this will come into effect from the end of 2024 onwards, but timelines may vary from country to country. Treatment alternatives are available.
- If you are using Norditropin NordiFlex, contact your doctor to discuss a suitable alternative.
- If you have any questions, speak to your doctor or pharmacist.
- Additional advice may be available from your country’s national shortage register or national competent authority.
Key facts
- Medicines affected
- Norditropin NordiFlex
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- somatropin
- Therapeutic area (MESH)
- Dwarfism, Pituitary
- Pharmaceutical forms affected
- Solution for injection in pre-filled pen
- Strengths affected
- 5 mg
- 10 mg
- 15 mg
- Availability of alternatives
- Yes
Key dates
- First published
- Last updated