Overview

The marketing authorisation for Equidacent has been withdrawn at the request of the marketing-authorisation holder.

Equidacent : EPAR - Medicine overview

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Equidacent : EPAR - Risk-management-plan summary

Product information

Equidacent : EPAR - Product information

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Latest procedure affecting product information: IB/0004

27/05/2021

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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).

Equidacent : EPAR - All authorised presentations

български (BG) (812.91 KB - PDF)
español (ES) (616.52 KB - PDF)
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dansk (DA) (616.02 KB - PDF)
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lietuvių kalba (LT) (788.17 KB - PDF)
magyar (HU) (714.71 KB - PDF)
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português (PT) (616.17 KB - PDF)
română (RO) (785.47 KB - PDF)
slovenčina (SK) (815.51 KB - PDF)
slovenščina (SL) (711.4 KB - PDF)
Suomi (FI) (615.22 KB - PDF)
svenska (SV) (615.92 KB - PDF)

Product details

Name of medicine
Equidacent
Active substance
bevacizumab
International non-proprietary name (INN) or common name
bevacizumab
Therapeutic area (MeSH)
  • Colorectal Neoplasms
  • Breast Neoplasms
  • Ovarian Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
Anatomical therapeutic chemical (ATC) code
L01XC07

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.

Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.

Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Equidacent in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1.

Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.

Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.

Bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer.

Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1).

Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.

Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Authorisation details

EMA product number
EMEA/H/C/005181

Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Marketing authorisation holder
Centus Biotherapeutics Europe Limited

6th Floor South Bank House
Barrow Street
Dublin 4
Ireland

Opinion adopted
23/07/2020
Marketing authorisation issued
24/09/2020
Revision
3

Assessment history

Equidacent : EPAR - Procedural steps taken and scientific information after authorisation

Equidacent : EPAR - Public assessment report

CHMP summary of positive opinion for Equidacent

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