Abiraterone Mylan - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

abiraterone acetate

Opinion

On 17 September 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Abiraterone Mylan. The marketing authorisation holder for this medicinal product is Mylan Pharmaceuticals Limited.

The CHMP adopted a change to an existing indication as follows and two new indications:

Abiraterone Mylan is indicated with prednisone or prednisolone for:

• the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult menpatients in combination with androgen deprivation therapy (ADT) (see section 5.1).
• the treatment of newly diagnosed mHSPC in adult patients in combination with ADT and docetaxel (see section 5.1) 
• the treatment of newly diagnosed high risk non-metastatic hormone sensitive prostate cancer (HSPC) in adult patients in combination with ADT and radiotherapy (see section 5.1).

For information, the full indications for Abiraterone Mylan will be as follows:

Abiraterone Mylan is indicated with prednisone or prednisolone for: 

• the treatment of newly diagnosed metastatic hormone sensitive prostate cancer (mHSPC) in adult patients in combination with androgen deprivation therapy (ADT) (see section 5.1). 
• the treatment of newly diagnosed mHSPC in adult patients in combination with ADT and docetaxel (see section 5.1) 
• the treatment of newly diagnosed high risk non-metastatic hormone sensitive prostate cancer (HSPC) in adult patients in combination with ADT and radiotherapy (see section 5.1) 
• the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). 
• the treatment of mCRPC in adult patients whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: Removed text as strikethrough, new text in bold.

CHMP post-authorisation summary of positive opinion for Abiraterone Mylan (VR-0000291298)

Adopted Reference Number: EMADOC-1700519818-3438133

Key facts

• Name of medicine:
  Abiraterone Mylan
• EMA product number:
  EMEA/H/C/005368
• Active substance:
  abiraterone acetate
• International non-proprietary name (INN) or common name:
  abiraterone acetate
• Therapeutic area (MeSH):
  Prostatic Neoplasms
• Anatomical therapeutical chemical (ATC) code:
  L02BX03
• Generic or hybrid:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Mylan Pharmaceuticals Limited
• Date of opinion:
  17/09/2026
• Status:
  Positive