Palbociclib Viatris (palbociclib)

Generic

Region: 🇪🇺 EU
Active substance: palbociclib
Company: Viatris Limited
Status: Authorised
Therapeutic area: Breast Neoplasms
CHMP opinion: Thu 23 Apr 2026
EU approval: Fri 19 Jun 2026
Designations: Generic
Application: EMEA/H/C/006624
ATC: L01EF01
Official record: www.ema.europa.eu

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.

Regulatory milestones

Fri 19 Jun 2026🇪🇺 EU approval (EC decision)

Palbociclib Viatris (palbociclib) approved in the EU

Marketing authorisation to Viatris Limited; Generic · source

Thu 23 Apr 2026🇪🇺 CHMP positive opinion

Palbociclib Viatris (palbociclib): CHMP positive opinion

Viatris Limited; Generic · source

Same substance in other markets

🇪🇺 Ibrance Authorised · Pfizer Europe MA EEIG

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.