Zavicefta

ceftazidime / avibactam

Table of contents

Opinion

On 17 September 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 an extension to the existing indication as follows:1

Zavicefta is indicated in adults and , infants (aged 3 months and older),children aged 3 months and older and adolescents for the treatment of the following infections in adults (see sections 4.4 and 5.1):

  • Complicated intra-abdominal infection (cIAI) (in combination with metronidazole)

  • Complicated urinary tract infection (cUTI), including pyelonephritis

Zavicefta is indicated in adults for the treatment of the following infections:

  • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) (see sections 4.4 and 5.1)

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 adults and children aged 3 months and older 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.


1New text in bold, removed text as strikethrough

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
17/09/2020
Company name
Pfizer Ireland Pharmaceuticals
Status
Positive
Application type
Post-authorisation

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