Palbociclib Viatris
- Prescription status not stated
- Cancer treatments and immune-system medicines
- Active substance
- Palbociclib
- Made by
- Viatris Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- 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.
From the official label · 2026-09-30 · European Medicines Agency
How it works
From the US prescribing label for the same active substance (Ibrance). It describes the substance, not this exact product.
Palbociclib is an inhibitor of cyclin-dependent kinases (CDK) 4 and 6.
Cyclin D1 and CDK4/6 are downstream of signaling pathways which lead to cellular proliferation.
Palbociclib was extensively metabolized with unchanged drug accounting for 2.3% and 6.9% of radioactivity in feces and urine, respectively.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-06
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
SpainNo exact match for this strength and form
FranceNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Viatris Limited |
|---|---|
| Active substance | Palbociclib |
| Used in | Cancer treatments and immune-system medicines |
| Classification | L01EF01 · Cancer treatments and immune-system medicines |
| Generic | Yes — a generic medicine, according to the register |
| Authorised on | 2026-06-19 |
| Last updated by the regulator | 2026-06-23 |
| EMA product number | EMEA/H/C/006624 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.