261 results
Keyword Inuver - Aerosol Remove keyword
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate, formoterol fumarate dihydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000548-PIP01-09-M08, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, Pressurised inhalation, solution
Decision date: 15/06/2018, Last updated: 21/09/2021, Compliance check: V, 26/04/2019Master and associated names Inuvair and associated names Beclometasone … Kantos and associated names, Inuvair.. PDF icon application/pdf … -
List item
Veterinary medicine European public assessment report (EPAR): Aservo EquiHaler
ciclesonide, Horses
Date of authorisation: 28/01/2020, Authorised, Last updated: 28/02/2020infection and headache. An aerosol filtering mask must be worn … -
List item
Human medicine European public assessment report (EPAR): Cayston
aztreonam lysine, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 21/09/2009, Revision: 20, Authorised, Last updated: 03/03/2023changes the solution into an aerosol that the patient can breathe … -
List item
Human medicine European public assessment report (EPAR): Ventavis
iloprost, Hypertension, Pulmonary
Date of authorisation: 15/09/2003, Revision: 29, Authorised, Last updated: 13/12/2021changes the solution into an aerosol that the patient can breathe … changes the solution into an aerosol that the patient can breathe … -
List item
Human medicine European public assessment report (EPAR): Colobreathe (updated)
Colistimethate sodium, Cystic Fibrosis
Date of authorisation: 13/02/2012, Revision: 14, Authorised, Last updated: 11/05/2023changes a solution into an aerosol that the patient can breathe … -
List item
Orphan designation: Human alpha1-proteinase inhibitor for: Treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency
Date of designation: 09/07/2001, Positive, Last updated: 28/03/2018inhibitor is made into an aerosol, which the patient can inhale … inhibitor is made into an aerosol, which the patient can inhale … -
List item
Orphan designation: Recombinant human alpha-1 antitrypsin for: Treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency
Date of designation: 30/04/2002, Withdrawn, Last updated: 13/01/2014The product is made into an aerosol, which the patient can inhale … -
List item
Orphan designation: Nafamostat mesilate for: Treatment of cystic fibrosis
Date of designation: 20/09/2010, Positive, Last updated: 18/10/2010to be given as an inhaled aerosol. What is the stage of development … be given as an inhaled aerosol. What is the stage of development … -
List item
Orphan designation: Recombinant human alpha-1 antitrypsin for: Treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency
Date of designation: 30/05/2001, Withdrawn, Last updated: 15/05/2009The product is made into an aerosol, which the patient can inhale … product is made into an aerosol, which the patient can inhale … -
List item
Orphan designation: Alpha-1 antitrypsin for: Treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency
Date of designation: 16/11/2004, Positive, Last updated: 07/05/2019inhalation use) is made into an aerosol, which the patient can inhale … inhalation use) is made into an aerosol, which the patient can inhale … -
List item
Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 20/07/2011,
, Revision: 20, Authorised, Last updated: 05/06/2023
changes a solution into an aerosol that the patient can breathe … changes a solution into an aerosol that the patient can breathe … -
List item
Orphan designation: Sodium cromoglicate for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 26/06/2020, Withdrawn, Last updated: 08/12/2020changes a solution into an aerosol that the patient can breathe … changes a solution into an aerosol that the patient can breathe … -
List item
Referral: Sanohex
salbutamol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/12/2008, EC decision date: 12/03/2009, Last updated: 30/03/2009salbutamol, metered dose aerosol inhaler, 100 μg/dose PDF … salbutamol, metered dose aerosol inhaler, 100 μg/dose The … Sanohex is a metered dose aerosol inhaler containing a suspension … -
List item
Referral: Sabumalin
salbutamol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/12/2008, EC decision date: 12/03/2009, Last updated: 30/03/2009salbutamol, metered dose aerosol inhaler, 100 μg/dose PDF … salbutamol, metered dose aerosol inhaler, 100 μg/dose The … -
List item
Orphan designation: Cysteamine for: Treatment of cystic fibrosis
Date of designation: 09/12/2011, Positive, Last updated: 21/05/2019is to be delivered as an aerosol directly into the patient's … -
List item
Orphan designation: Tobramycin for: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Date of designation: 28/02/2009, Withdrawn, Last updated: 09/02/2018changes the solution into an aerosol so that the patient can breathe … -
List item
Orphan designation: Sodium nitrite for: Treatment of pulmonary arterial hypertension
Date of designation: 05/03/2012, Positive, Last updated: 06/07/2012changes a solution into an aerosol that the patient can breathe … changes a solution into an aerosol that the patient can breathe … -
List item
Orphan designation: Colistimethate sodium for: Treatment of Pseudomonas aeruginosa lung infection (including colonisation) in cystic fibrosis
Date of designation: 19/02/2002, Withdrawn, Last updated: 18/11/2011oral, intravenous and as an aerosol via nebulisation. Several … oral, intravenous and as an aerosol via nebulisation. Several … -
List item
Orphan designation: Tobramycin for: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Date of designation: 17/03/2003, Positive, Last updated: 03/04/2023oral, intravenous and as an aerosol via nebulisation. Several … oral, intravenous and as an aerosol via nebulisation. Several … -
List item
Orphan designation: Ciprofloxacin for: Treatment of cystic fibrosis
Date of designation: 24/07/2009, Positive, Last updated: 06/04/2022changes the solution into an aerosol that the patient can breathe … changes the solution into an aerosol that the patient can breathe … -
List item
Orphan designation: Multilamellar microvesicle comprising phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol and cholesterol for: Treatment of cystic fibrosis
Date of designation: 30/08/2011, Withdrawn, Last updated: 06/04/2022changes the solution into an aerosol that the patient can breathe … changes the solution into an aerosol that the patient can breathe … -
List item
Orphan designation: Aztreonam lysinate for: Treatment of Gram-negative bacterial lung infection in cystic fibrosis
Date of designation: 21/06/2004, Expired, Last updated: 16/10/2019oral, intravenous and as an aerosol via nebulisation in the lungs … -
List item
Orphan designation: ciclosporin for: Prevention of graft rejection after lung transplantation
Date of designation: 29/07/2004, Positive, Last updated: 10/07/2019European Commission to PARI Aerosol Research Institute, Germany … European Commission to PARI Aerosol Research Institute, Germany … -
List item
National expert: Ralf Reinhard Tönjes, Paul-Ehrlich-Institut (updated)
- Declaration of interests - 41.48 KB | PDF
- Curriculum Vitae - 199.06 KB | PDF
Fraunhofer_Institute for Toxicology and Aerosol_Research, Division of Cell Biology … Fraunhofer_Institute for Toxicology and Aerosol_Research, Division of Cell Biology … -
List item
Orphan designation: Pegylated recombinant anti-Pseudomonas aeruginosa antibody for: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Date of designation: 05/08/2013, Withdrawn, Last updated: 06/03/2015changes the solution into an aerosol so that the patient can breathe … changes the solution into an aerosol so that the patient can breathe …