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Ciprofloxacin

Linhaliq

Extended indication Bronchiectasis in non-cystic fibrosis patients with chronic respiratory infections due to Pseudomona
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Ciprofloxacin
Domain Lung diseases
Reason of inclusion New medicine (specialité)
Main indication Lung other
Extended indication Bronchiectasis in non-cystic fibrosis patients with chronic respiratory infections due to Pseudomonas aeruginosa - first-line for prevention of pulmonary exacerbations
Proprietary name Linhaliq
Manufacturer Aradigm
Route of administration Inhalation
Therapeutical formulation Nebulizing fluid
Budgetting framework Extramural (GVS)
Additional remarks Once-a-day inhaled formulation consisting of a mixture of unencapsulated ciprofloxacin and ciprofloxacin encapsulated in liposomes, delivering immediate and sustained release of the drug within the lung.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
Submission date April 2018
Expected Registration February 2019
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options ciprofloxacin
Therapeutic value No judgement
Substantiation Liposomale inhalatie is nieuw.
Frequency of administration 1 times a day

Expected patient volume per year

Patient volume

< 295,150

Market share is generally not included unless otherwise stated.
References GIP-databank
Additional remarks Het aantal gebruikers van ciprofloxacin in 2016 betrof 295150 patiënten. Een deel van deze patiënten zal in aanmerking komen voor deze nieuwe formulering.

Expected cost per patient per year

Additional remarks De prijs zal naar verwachting competitief zijn aan huidige vormen van ciprofloxacin.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.