Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 05 September 2018
TOBI Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.
View disease awareness information, treatment options and European Cystic Fibrosis Society best practice guidelines.
The Atopic Dermatitis Knowledge Centre is an educational resource, intended for healthcare professionals, that provides credible medical information on the epidemiology, pathophysiology and burden of atopic dermatitis, as well as diagnostic techniques, treatment regimens and guideline recommendations.
Discover an overview of hypophosphatasia and details required to facilitate the timely and accurate detection of low alkaline phosphatase.
The CDK 4/6 Inhibitors in Metastatic Breast Cancer Learning Zone provides insights and information for metastatic breast cancer (mBC) and CDK 4/6 signalling. This includes the burden and pathophysiology of the disease, the role of CDK 4/6 in cell proliferation and an overview of the CDK 4/6 inhibitors that have been approved for the management of mBC.
Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways
The objective of this study is to evaluate safety of treatment with AZLI 75 mg 3 times daily (TID) for...
Added 8 years ago
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o. (ACCORD)
The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective and safe in...
Added 3 years ago
A Study in Belgian Children Hospitalized With Respiratory Syncytial Virus Related Acute Respiratory Infections
The purpose of the study is to assess viral kinetics and clinical symptoms kinetics in pediatric patients hospitalized with Respiratory...
Added 5 years ago
A Prospective, Epidemiological Study to Assess the Disease Burden of Respiratory Syncytial Virus Associated, Suspected Lower Respiratory Tract Infections in Newborns, From Birth up to 2 Years of Age
The purpose of this study is to assess the incidence and associated healthcare utilization of RSV-associated, suspected LRTI in a...
Added 6 years ago
Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis
Nasal continuous positive airway pressure (nCPAP), widely used in neonatal intensive care is also more and more used in infants...
Added 6 years ago
Pseudomonas aeruginosa in cystic fibrosis patients with c.1652G›A (G551D)-CFTR treated with ivacaftor-Changes in microbiological parameters.
The CFTR potentiator, ivacaftor (IVA), has been widely used in the treatment of cystic fibrosis (CF) patients with the G551D mutation. To date, there has been limited information on the microbiological status...
Added 11 months ago
Introduction: Lumacaftor-ivacaftor is indicated for treatment of cystic fibrosis (CF) in patients homozygous for the Phe-508del cystic fibrosis transmembrane conductance regulator (CFTR) gene mutations.
Added 1 year ago
Tobramycin inhalation powder (TOBI Podhaler(®)) for the treatment of lung infection in patients with cystic fibrosis.
Cystic fibrosis (CF) is an autosomal recessive inherited disease secondary to a defect in the CF transmembrane conductance regulator gene...
Added 3 years ago
Ivacaftor treatment of cystic fibrosis in children aged 12 to <24 months and with a CFTR gating mutation (ARRIVAL): a phase 3 single-arm study.
Background: Ivacaftor is generally safe and effective in patients aged 2 years and older who have cystic fibrosis and specific CFTR mutations. We assessed its use in children aged 12 to <24 months.
Added 6 months ago
This guideline covers diagnosing and managing cystic fibrosis. It specifies how to monitor the condition and manage the symptoms to improve quality of life.
Added 7 months ago
Specialised CF care has led to a dramatic improvement in survival in CF: in the last four decades, well above what was seen in the general population over the same period.
Added 4 years ago
Palliative care is an approach that improves quality of life for patients and their families facing problems associated with a life-threatening illness. Care planning is particularly important in CF...
Added 7 years ago
Approximately 5–10% of cystic fibrosis (CF) patients develop multilobular cirrhosis during the first decade of life. Most CF patients later develop signs of portal hypertension with complications, mainly variceal bleeding.
Added 7 years ago
|Agency product number||EMEA/H/C/002155|
|Date First Approved||20-07-2011|
|Type||Medicinal product subject to medical prescription|
|Marketing authorisation holder||Novartis Europharm Limited|