Atazanavir Krka

Withdrawn

This medicine's authorisation has been withdrawn

atazanavir

Overview

On 23 February 2026 the European Commission withdrew the marketing authorisation for Atazanavir Krka (atazanavir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, KRKA, d.d., Novo mesto, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Atazanavir Krka was granted marketing authorisation in the EU on 25 March 2019 for the treatment of HIV-1 infection. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2023.

Atazanavir Krka is a generic medicine of Reyataz. There are other generic medicinal products of Reyataz authorised and marketed in the EU. 

Atazanavir Krka : EPAR - Medicine overview

Reference Number: EMA/107659/2019

Atazanavir Krka : EPAR - Risk-management-plan summary

Product information

Atazanavir Krka : EPAR - Product information

Atazanavir Krka : EPAR - All authorised presentations

Product details

• Name of medicine:
  Atazanavir Krka
• Active substance:
  atazanavir (as sulfate)
• International non-proprietary name (INN) or common name:
  atazanavir
• Therapeutic area (MeSH):
  HIV Infections
• Anatomical therapeutic chemical (ATC) code:
  J05AE08

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Atazanavir Krka capsules, co-administered with low dose ritonavir, are indicated for the treatment of HIV-1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.

Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (? 4 PI mutations).

The choice of Atazanavir Krka in treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.

Authorisation details

• EMA product number:
  EMEA/H/C/004859
• Generic:

  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:
  Krka, d.d., Novo mesto

  KRKA d.d., Novo mesto; Šmarješka cesta 6; SI-8501 Novo mesto; Slovenia

• Opinion adopted:
  31/01/2019
• Marketing authorisation issued:
  25/03/2019
• Withdrawal of marketing authorisation:
  23/02/2026
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Atazanavir Krka : EPAR - Procedural steps taken and scientific information after authorisation

Atazanavir Krka : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Initial marketing authorisation documents

Atazanavir Krka : EPAR - Public assessment report

Adopted Reference Number: EMA/119506/2019

CHMP summary of positive opinion for Atazanavir Krka

Adopted Reference Number: EMA/CHMP/17181/2019