Palbociclib Viatris
Authorised
This medicine is authorised for use in the European Union
palbociclib
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Palbociclib Viatris is a cancer medicine used to treat breast cancer when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). Palbociclib Viatris can only be used when the cancer cells have receptors (targets) for certain hormones on their surface (HR-positive) and do not produce abnormally large quantities of a receptor called HER2 (HER [human epidermal growth factor] negative). Palbociclib Viatris is used in the following ways:
- together with an aromatase inhibitor (a hormonal medicine for cancer);
- together with fulvestrant (another hormonal medicine for cancer) in patients who have previously been treated with a hormonal medicine.
In women who have not yet reached menopause, a medicine called a luteinising hormone-releasing hormone agonist should also be given.
Palbociclib Viatris contains the active substance palbociclib and is a ‘generic medicine’. This means that Palbociclib Viatris contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Palbociclib Viatris is Ibrance. For more information on generic medicines, see the question-and-answer document here.
Palbociclib Viatris can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Palbociclib Viatris is available as tablets taken by mouth. It should be taken once a day for 21 consecutive days, followed by a 7-day break to complete a 28-day treatment cycle. Treatment should continue for as long as the patient is benefitting from it and side effects are tolerable. If the patient experiences certain side effects, treatment may need to be interrupted or stopped, or the dose reduced.
For more information about using Palbociclib Viatris, see the package leaflet or contact your doctor or pharmacist.
The active substance in Palbociclib Viatris, palbociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which play a key role in regulating the way cells grow and divide. In some cancers, including HR-positive breast cancer, the activity of CDK 4 and 6 is increased, which helps the cancer cells to multiply uncontrollably. By blocking CDK4 and CDK6, Palbociclib Viatris slows the growth of HR-positive breast cancer cells.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Ibrance, and do not need to be repeated for Palbociclib Viatris.
As for every medicine, the company provided studies on the quality of Palbociclib Viatris. The company also carried out studies 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 Palbociclib Viatris 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, Palbociclib Viatris has been shown to have comparable quality and to be bioequivalent to Ibrance. Therefore, the Agency’s view was that, as for Ibrance, the benefits of Palbociclib Viatris 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 Palbociclib Viatris have been included in the summary of product characteristics and the package leaflet. Any additional measures in place for Ibrance also apply to Palbociclib Viatris where appropriate.
As for all medicines, data on the use of Palbociclib Viatris are continuously monitored. Side effects reported with Palbociclib Viatris are carefully evaluated and any necessary action taken to protect patients.
Palbociclib Viatris received a marketing authorisation valid throughout the EU on 19 June 2026.
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
- Palbociclib Viatris
- Active substance
- Palbociclib
- International non-proprietary name (INN) or common name
- palbociclib
- Therapeutic area (MeSH)
- Breast Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01EF01
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Palbociclib Viatris is indicated for the treatment of hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative locally advanced or metastatic breast cancer.
- in combination with an aromatase inhibitor;
- in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1).
In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist.
News on Palbociclib Viatris
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