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Pharmaceuticals - Community Register
List of referrals for human medicinal products
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|
|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|