311 results
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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 … salbutamol, metered dose aerosol inhaler, 100 μg/dose The … Sanohex is a metered dose aerosol inhaler containing a suspension … -
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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 … salbutamol, metered dose aerosol inhaler, 100 μg/dose The … -
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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 … -
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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Date of designation: 28/02/2009, Withdrawn, Last updated: 09/02/2018changes the solution into an aerosol so that the patient can breathe … -
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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 … -
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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Date of designation: 19/02/2002, Withdrawn, Last updated: 18/11/2011oral, intravenous and as an aerosol via nebulisation.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 … -
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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 … -
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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 … -
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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 … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014
CHMP, Last updated: 26/09/2014Vylaer Spiromax … -
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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 … -
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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 … -
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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 … -
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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 … -
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National expert: Jens-Uwe Bleich, Norwegian Medicines Agency (updated)
- Declaration of interests - 40.09 KB | PDF
- Curriculum Vitae - 25.79 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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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva
Budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive; Asthma
Date of authorisation: 19/11/2014, Revision: 2, Withdrawn, Last updated: 31/01/2017Budesonide/Formoterol Teva was a duplicate of DuoResp Spiromax, which is marketed in several … -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
Budesonide, formoterol, Asthma
Date of authorisation: 19/11/2014, Revision: 1, Withdrawn, Last updated: 30/01/2017Budesonide/Formoterol Teva Pharma B.V. was of DuoResp Spiromax, which is marketed in several … -
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National expert: Anita Simonds, European Medicines Agency (updated)
- Declaration of interests - 41.22 KB | PDF
- Curriculum Vitae - 38.29 KB | PDF
patients with COVID_19 receiving aerosol_generating procedures. Thorax 2021 doi:10.1136/thoraxjnl_2021_218035 … evidence gaps and the risks of aerosol transmission of SARS_CoV_2 … -
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Human medicine European public assessment report (EPAR): Revinty Ellipta
fluticasone furoate, vilanterol trifenatate, Asthma
Date of authorisation: 02/05/2014, Revision: 21, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Relvar Ellipta
fluticasone furoate, vilanterol, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 13/11/2013, Revision: 24, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
Budesonide, formoterol fumarate dihydrate, Asthma; Pulmonary Disease, Chronic Obstructive
Date of authorisation: 03/04/2020, Revision: 2, Authorised, Last updated: 08/12/2021leaves the mouthpiece of the Spiromax) contains 160 micrograms of … -
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National expert: Heidi Mestl, Norwegian Medicines Agency (updated)
- Declaration of interests - 39.26 KB | PDF
- Curriculum Vitae - 188.96 KB | PDF
Emissions of Carbonaceous Aerosol and Other Air Pollutants … Mellouki, Fahe Chai, Shulan Wang. Aerosol and Air Quality Research … -
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National expert: Kaisa Mari Hämäläinen, Finnish Medicines Agency (updated)
- Declaration of interests - 39.41 KB | PDF
- Curriculum Vitae - 32.19 KB | PDF
of asthma in children. J Aerosol Med 2004, 17:15_24. 2. Toropainen … -
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Human medicine European public assessment report (EPAR): Regkirona
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,
, Revision: 7, Authorised, Last updated: 21/04/2023
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Human medicine European public assessment report (EPAR): Imvanex
modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013,, 
, Revision: 25, Authorised, Last updated: 29/03/2023