Pomalidomide Zentiva
Authorised
This medicine is authorised for use in the European Union
pomalidomide
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Pomalidomide Zentiva is a cancer medicine used to treat multiple myeloma (a cancer of the bone marrow). It is used in combination with bortezomib (another cancer medicine) and dexamethasone (an anti-inflammatory medicine) in adults who have received at least one treatment including lenalidomide (another cancer medicine).
It is also used in combination with dexamethasone in adults who have received at least two prior therapies, including both lenalidomide and bortezomib, and whose disease has worsened.
Pomalidomide Zentiva contains the active substance pomalidomide and is a ‘generic medicine’. This means that Pomalidomide Zentiva contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Pomalidomide Zentiva is Imnovid. For more information on generic medicines, see the question-and-answer document here.
Treatment with Pomalidomide Zentiva must be started and supervised by a doctor experienced in treating multiple myeloma. The medicine can only be obtained with a prescription.
Pomalidomide Zentiva is available as capsules. It is taken daily in the first 2 weeks of 3-week treatment cycles, when given in combination with bortezomib and dexamethasone, and in the first 3 weeks of 4-week treatment cycles when given in combination with dexamethasone only.
Treatment with Pomalidomide Zentiva may need to be interrupted or stopped, or the dose may need to be reduced, if the disease gets worse or certain side effects occur. For more information about using Pomalidomide Zentiva, see the package leaflet or contact your doctor or pharmacist.
The active substance in Pomalidomide Zentiva, pomalidomide, is an immunomodulating agent. This means that it affects the activity of the immune system (the body’s natural defences). Pomalidomide works in a number of ways in multiple myeloma: it blocks the development of tumour cells, prevents the growth of blood vessels within tumours and also stimulates some specialised cells of the immune system to attack the tumour cells.
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Imnovid, and do not need to be repeated for Pomalidomide Zentiva.
As for every medicine, the company provided studies on the quality of Pomalidomide Zentiva. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Because Pomalidomide Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The European Medicines Agency concluded that, in accordance with EU requirements, Pomalidomide Zentiva has been shown to have comparable quality and to be bioequivalent to Imnovid. Therefore, the Agency’s view was that, as for Imnovid, the benefits of Pomalidomide Zentiva outweigh the identified risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pomalidomide Zentiva have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Imnovid, such as a patient card with key safety information, also apply to Pomalidomide Zentiva where appropriate.
As for all medicines, data on the use of Pomalidomide Zentiva are continuously monitored. Suspected side effects reported with Pomalidomide Zentiva are carefully evaluated and any necessary action taken to protect patients.
Pomalidomide Zentiva received a marketing authorisation valid throughout the EU on 24 July 2024.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Pomalidomide Zentiva
- Active substance
- Pomalidomide
- International non-proprietary name (INN) or common name
- pomalidomide
- Therapeutic area (MeSH)
- Multiple Myeloma
- Anatomical therapeutic chemical (ATC) code
- L04AX06
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Treatment of adults with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
Pomalidomide Zentiva in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
News on Pomalidomide Zentiva
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