Zinforo

ceftaroline fosamil

Opinion

On 27 June 2019, 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 Zinforo. The marketing authorisation holder for this medicinal product is Pfizer Ireland Pharmaceuticals.

The CHMP adopted an extension to the existing indication as follows*:

“Zinforo is indicated for the treatment of the following infections in adults neonates, infants, children, and children adolescents and adults from the age of 2 months (see sections 4.4 and 5.1):

  • Complicated skin and soft tissue infections (cSSTI)
  • Community-acquired pneumonia (CAP)

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.


*New text in bold, removed text as strikethrough

Key facts

Name
Zinforo
Agency product number
EMEA/H/C/002252
International non-proprietary name (INN) or common name
  • ceftaroline fosamil
Active substance
  • Ceftaroline fosamil
Therapeutic area
Community-Acquired Infections
Skin Diseases, Infectious
Pneumonia
Date opinion adopted
27/06/2019
Company name
Pfizer Ireland Pharmaceuticals
Status
Positive
Application type
Post-authorisation

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