Perjeta (pertuzumab)
- Region
- 🇪🇺 EU
- Active substance
- pertuzumab
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- EU approval
- Mon 04 Mar 2013
- Application
- EMEA/H/C/002547
- ATC
- L01FD02
- Official record
- www.ema.europa.eu
Indication
Metastatic Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. Neoadjuvant Treatment of Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Phesgo Authorised · Roche Registration GmbH
- 🇪🇺 Poherdy Authorised · Organon N.V.
- 🇪🇺 Pebrilzo Opinion · Biosimilar Collaborations Ireland Limited
- 🇺🇸 Poherdy Approved · Shanghai Henlius Biotech
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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.