Zavicefta

ceftazidime / avibactam

Table of contents

Opinion

On 25 June 2020, 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 Zavicefta. The marketing authorisation holder for this medicinal product is Pfizer Ireland Pharmaceuticals.

The CHMP adopted a new indication as follows:

“Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above”.

For information, the full indications for Zavicefta will be as follows: 1

Zavicefta is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1):

  • Complicated intra-abdominal infection (cIAI)
  • Complicated urinary tract infection (cUTI), including pyelonephritis
  • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)

Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.

Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options (see sections 4.2, 4.4 and 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

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


1 New text in bold

Key facts

Name
Zavicefta
Agency product number
EMEA/H/C/004027
International non-proprietary name (INN) or common name
  • ceftazidime / avibactam
Active substance
  • Ceftazidime
  • avibactam
Therapeutic area
Pneumonia, Bacterial
Soft Tissue Infections
Pneumonia
Urinary Tract Infections
Gram-Negative Bacterial Infections
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Date opinion adopted
25/06/2020
Company name
Pfizer Ireland Pharmaceuticals
Status
Positive
Application type
Post-authorisation

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