Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1816680
Name of medicinal product: TIGECYCLINE ACCORD
Active substances:
Tigecycline
Estonian, English, Latin
ATC code: J01AA12
Dosage form: powder for solution for infusion
Route of administration: intravenous use
Strengh: 50mg
Amount in package: 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Tigecycline Accord is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1): -Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4); -Complicated intra-abdominal infections (cIAI). Tigecycline Accord should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 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: August 21, 2023
Marketing authorization holder: Accord Healthcare S.L.U. 
Marketing authorization number: EU/1/19/1394 
Marketing authorization issued on: April 17, 2020 
Marketing authorization expires on: April 20, 2025 
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: April 29, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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