Pazenir - supply shortage
Ongoing
paclitaxel
Shortage
Human
Shortage information
Pazenir is used to treat:
- metastatic breast cancer, when the first treatment has stopped working and standard treatment including an anthracycline is not suitable;
- metastatic adenocarcinoma of the pancreas, as a first treatment in combination with another cancer medicine, gemcitabine;
- non-small cell lung cancer, as a first treatment in combination with the cancer medicine carboplatin when the patient cannot have surgery or radiotherapy.
There has been an increase in demand in Europe for albumin-bound nanoparticle paclitaxel throughout 2023, which has led to a limited supply or shortage of Pazenir in most EU Member States where it is marketed. The company that markets Pazenir has since made the commercial decision to stop marketing the medicine in the majority of EU Member States in order to redistribute supplies to countries outside the EU. This will last at least until the end of 2024. Member States affected by the decision will be notified by the company of the expected start date of the market withdrawal.
Austria, Bulgaria, Croatia, Czechia, Estonia, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Portugal, Romania, Slovakia, Slovenia and Spain.
This information may change. For up-to-date information about the status of a medicine shortage in a particular Member State, contact the national competent authority.
EMA’s SPOC working party is aware of the impact of this commercial decision on patients and is closely monitoring the supply situation. Commercial decisions are made independently of EMA. The working party is liaising with the marketing authorisation holder and also engaging with other stakeholders 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.
- There has been an increase in demand in Europe for albumin-bound nanoparticle paclitaxel throughout 2023, which has led to a shortage of Pazenir.
- The company that markets Pazenir has since made the commercial decision to stop marketing the medicine in the majority of EU Member States so that supplies can be redistributed to countries outside the EU. This is expected to last at least until the end of 2024.
- Pazenir will still be available in France, Germany and Sweden throughout 2024.
- Healthcare professionals should consider alternative treatment options for their existing patients if Pazenir is not available in their country.
- Pazenir treatment should not be started for new patients.
- A direct healthcare professional communication (DHPC) on the Pazenir shortage was previously sent to healthcare professionals in affected Member States.
- Additional advice, including information on suitable alternatives, may be available from your national shortage register or national competent authority.
- Pazenir contains the cancer medicine paclitaxel attached to the human protein albumin, in the form of tiny particles known as nanoparticles (albumin-bound nanoparticle paclitaxel).
- There has been an increase in demand in Europe for albumin-bound nanoparticle paclitaxel, which has led to a shortage of Pazenir in some EU countries.
- The company that markets Pazenir has since decided to stop marketing the medicine in most EU Member States and redistribute supplies to countries outside the EU. This will last at least until 2024.
- Your doctor will prescribe you a treatment alternative if Pazenir is not available.
- If you have any questions, speak to your doctor or pharmacist.
- Additional advice may be available from your national shortage register or national competent authority.
Key facts
- Medicines affected
- Pazenir
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- paclitaxel
- Therapeutic area (MESH)
- Breast Neoplasms
- Pharmaceutical forms affected
- Powder for dispersion for infusion
- Strengths affected
- 5 mg/ml
- Availability of alternatives
- Yes
Key dates
- Expected resolution
- Shortage will last at least until the end of 2024
- First published
- Last updated