Menopur - supply shortage
Ongoing
menotropin
Shortage
Human
Shortage information
Menopur is used to treat female and male infertility.
In October 2022, the marketing authorisation holder, Ferring, suspended supply of Menopur (all presentations). This was a precautionary measure after the company had been made aware of unapproved changes in the manufacturing process of the active substance of Menopur. As a result, supplies of all presentations are constrained in EU Member States. The data available to date do not indicate any immediate safety issue due to the changes in the manufacturing process.
Menopur has been or may be temporarily suspended in the following EU Member States: Austria, Bulgaria, Croatia, Cyprus, Czechia, Greece, Hungary, Italy, Poland, Portugal, Romania, Slovakia, Slovenia, and Spain. Shortages are possible in all other EU Member States where the product continues to be marketed.
EMA’s SPOC working party is closely monitoring the supply situation and engaging with Ferring to obtain the necessary approvals and resume supply. The SPOC working party is also meeting with manufacturers of alternative medicines to ensure patients can continue to be treated.
The SPOC working party is responsible for monitoring and reporting events that could affect the supply of medicines in the EU.
- All shipments of Menopur were temporarily suspended which resulted in a shortage of the medicine that may continue through 2025 in some EU countries.
- In view of the lack of alternatives in several Member States, Menopur manufactured with unapproved changes may continue to be supplied and used, based on national decision.
- In Member States where Menopur is no longer available, alternatives should be used.
- A direct healthcare professional communication (DHPC) has been sent to healthcare professionals where needed.
- For additional information consult your country’s shortage register or contact your national competent authority
- All shipments of Menopur were temporarily suspended which resulted in a shortage of the medicine which may continue through 2025 in some EU countries.
- In view of the lack of alternatives in several Member States, Menopur manufactured with unapproved changes may continue to be supplied and used based on national decision.
- In Member States where Menopur is no longer available, alternatives should be used in consultation with a healthcare professional.
- Patients who have any questions should speak to their doctor or pharmacist.
- For additional information consult your country’s shortage register or contact your national competent authority.
Key facts
- Medicines affected
- Menopur
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- menotropin
- Therapeutic area (MESH)
- Infertility
- Pharmaceutical forms affected
- Powder and solvent for solution for injection
- Strengths affected
- 1200 IU
- Availability of alternatives
- Yes
Key dates
- Expected resolution
- End of 2025
- First published
- Last updated