Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1842106
Name of medicinal product: XERAVA
Active substances:
Eravacycline
Estonian, English, Latin
ATC code: J01AA13
Dosage form: powder for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 100mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Xerava is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adults (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: PAION Deutschland GmbH 
Marketing authorization number: EU/1/18/1312 
Marketing authorization issued on: September 20, 2018 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Hambaarstil on õigus välja kirjutada
Entry/Changing date: July 19, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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