Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use

Zinacef and associated names

Product name: Zinacef and associated names
Also marketed in the EU under the name(s): Cefuroxima Allen, Cefuroxima Solasma, Elobact, NIVADOR, Oraxim, SELAN, Zinadol, Zipos, Zoref
Active substance: Cefuroxime (cefuroxime sodium)
Indication: Zinacef is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth) (see sections 4.4 and 5.1).
- Community acquired pneumonia.
- Acute exacerbations of chronic bronchitis.
- Complicated urinary tract infections, including pyelonephritis.
- Soft-tissue infections: cellulitis, erysipelas and wound infections.
- Intra-abdominal infections (see section 4.4).
- Prophylaxis against infection in gastrointestinal (including oesophageal), orthopaedic, cardiovascular, and gynaecological surgery (including caesarean section).
In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Authorisation Holder: GlaxoSmithKline

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
11/09/2012 Referral EMEA/H/A-30/1158 (2012)6401 of 10/09/2012
17/12/2015 Rectificative Decision (2015)9604 of 15/12/2015