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).

1. Product

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

2. 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.

3. Therapeutic value

Therapeutic value
Potential equal value
Duration of treatment
Not found

4. Expected patient volume per year

Patiëntvolume is niet van toepassing bij generieke geneesmiddelen of biosimilars.

5. Expected cost per patient per year

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

6. Potential total cost per year

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

7. 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.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.