203 results
Keyword Broxol - Aerosol Remove keyword
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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 … -
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Human medicine European public assessment report (EPAR): Colobreathe
Colistimethate sodium, Cystic Fibrosis
Date of authorisation: 13/02/2012, Revision: 12, Authorised, Last updated: 17/11/2020changes a solution into an aerosol that the patient can breathe … -
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Human medicine European public assessment report (EPAR): Cayston
aztreonam lysine, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 21/09/2009, Revision: 18, Authorised, Last updated: 06/07/2020changes the solution into an aerosol that the patient can breathe … -
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Orphan designation: Human alpha1-proteinase inhibitor for: Treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency
Date of first decision: 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 … -
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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/107.53 … salbutamol, metered dose aerosol inhaler, 100 μg/dose The … Sanohex is a metered dose aerosol inhaler containing a suspension … -
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Orphan designation: Recombinant human alpha-1 antitrypsin for: Treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency
Date of first decision: 30/04/2002, Withdrawn, Last updated: 13/01/2014The product is made into an aerosol, which the patient can inhale … -
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Orphan designation: Nafamostat mesilate for: Treatment of cystic fibrosis
Date of first decision: 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 … -
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Orphan designation: Recombinant human alpha-1 antitrypsin for: Treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency
Date of first decision: 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 … -
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Human medicine European public assessment report (EPAR): Ventavis
iloprost, Hypertension, Pulmonary
Date of authorisation: 15/09/2003, Revision: 28, Authorised, Last updated: 01/02/2021changes the solution into an aerosol that the patient can breathe … changes the solution into an aerosol that the patient can breathe … -
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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/108.61 … salbutamol, metered dose aerosol inhaler, 100 μg/dose The … -
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Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 20/07/2011,
, Revision: 17, Authorised, Last updated: 24/02/2021
changes a solution into an aerosol that the patient can breathe … changes a solution into an aerosol that the patient can breathe … -
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Orphan designation: Alpha-1 antitrypsin for: Treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency
Date of first decision: 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 … -
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National expert: Dominique Bullens, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 81.36 KB | PDF
- Curriculum Vitae - 36.7 KB | PDF
of Sodiumchromoglycate in aerosol compared to placebo (NaCl … -
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National expert: Gustavo Adolfo Centeno Soto, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 83.98 KB | PDF
- Curriculum Vitae - 17.59 KB | PDF
Ciclosporine A liposomic aerosolized Prevention of bronchiolitis … -
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National expert: Ralf Reinhard Tönjes, Paul-Ehrlich-Institute (updated)
- Declaration of interests - 80.23 KB | PDF
- Curriculum Vitae - 25.61 KB | PDF
scientist Fraunhofer-Institute for Toxicology and Aerosol-Research, Division of Cell Biology, Hannover … Biology Fraunhofer-Institute for Toxicology and Aerosol-Research, Division of Cell Biology, Hannover … -
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National expert: Jens-Uwe Bleich, Norwegian Medicines Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 17.58 KB | PDF
B.W. and Waßmus, W. (1993) Aerosol Solvent Extraction System … abbaubarer Mikropartikel mit dem Aerosol Solvent Extraction System … supercritical gases with the Aerosol Solvent Extraction System … -
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Orphan designation: Cysteamine for: Treatment of cystic fibrosis
Date of first decision: 09/12/2011, Positive, Last updated: 21/05/2019is to be delivered as an aerosol directly into the patient's … -
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Orphan designation: Sodium nitrite for: Treatment of pulmonary arterial hypertension
Date of first decision: 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 … -
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Orphan designation: Colistimethate sodium for: Treatment of Pseudomonas aeruginosa lung infection (including colonisation) in cystic fibrosis
Date of first decision: 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 … -
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Orphan designation: Sodium cromoglicate for: Treatment of idiopathic pulmonary fibrosis
Date of first decision: 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 … -
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Orphan designation: Multilamellar microvesicle comprising phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol and cholesterol for: Treatment of cystic fibrosis
Date of first decision: 30/08/2011, Positive, Last updated: 27/08/2020changes the solution into an aerosol that the patient can breathe … changes the solution into an aerosol that the patient can breathe … -
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Orphan designation: Tobramycin for: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Date of first decision: 17/03/2003, Positive, Last updated: 01/07/2019oral, intravenous and as an aerosol via nebulisation. Several … oral, intravenous and as an aerosol via nebulisation. Several … -
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Veterinary medicine European public assessment report (EPAR): Respiporc Flu3 (updated)
inactivated influenza-A virus / swine, Pigs
Date of authorisation: 14/01/2010, Revision: 5, Authorised, Last updated: 16/02/2021 -
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Human medicine European public assessment report (EPAR): Quinsair
levofloxacin, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 25/03/2015,
, Revision: 12, Authorised, Last updated: 15/12/2020
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Human medicine European public assessment report (EPAR): Trimbow (updated)
Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 17/07/2017, Revision: 4, Authorised, Last updated: 26/02/2021