Tigecycline

Active substance Tigecycline
Domain Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen Generic
Main indication Bacterial infections
Extended indication Tigecycline Accord is indicated in adults and in children from the age of eight years for the treatment of the following infections: Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections; Complicated intra-abdominal infections (cIAI).

Product

Current proprietary name Tygacil (Pfizer)
Proprietary name Tigecycline Accord
Manufacturer Accord Healthcare
Mechanism of action Antibiotic

Registration

Registration route Centralised (EMA)
Submission date August 2018
Expected Registration April 2020
Orphan drug No
Registration phase Registered
Additional comments SPC Tygacil is verlopen. Positieve CHMP-opinie in februari 2020. Geregistreerd in april 2020.

Therapeutic value

Therapeutic value Potential equal value
Duration of treatment Not found

Expected patient volume per year

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

Expected cost per patient per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

Potential total cost per year

Horizonscan vermeldt geen prijsinformatie van generieke geneesmiddelen of biosimilars om het eventueel beïnvloeden van de markt te voorkomen.

Off label use

Off label use Yes
Indications off label use Behandeling van Mycobacterium abscessus infecties
References Floto et al., Thorax 2016 Jan;71 Suppl 1:i1-22 ; Haworth et al., Thorax Nov;72(Suppl 2):ii1-ii64.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.