307 results
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Human medicine European public assessment report (EPAR): DuoResp Spiromax
budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive; Asthma
Date of authorisation: 28/04/2014, Revision: 11, Authorised, Last updated: 09/06/2021DuoResp Spiromax Respiratory Tract Diseases Lung … budesonideformoterol Overview DuoResp Spiromax is a medicine that contains … formoterol) taken by inhalation. DuoResp Spiromax is also used to relieve the … -
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Human medicine European public assessment report (EPAR): Vylaer Spiromax
budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive; Asthma
Date of authorisation: 19/11/2014, Revision: 3, Withdrawn, Last updated: 26/01/2017Vylaer Spiromax Pulmonary Disease, Chronic … authorisation for Vylaer Spiromax has been withdrawn at the … Summary documents Vylaer Spiromax : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): BroPair Spiromax
salmeterol xinafoate, fluticasone propionate, Asthma
Date of authorisation: 26/03/2021, Revision: 1, Authorised, Last updated: 27/08/2021BroPair Spiromax Respiratory Tract Diseases Bronchial … propionate Overview BroPair Spiromax is a medicine used for the … fluticasone. How is BroPair Spiromax used? The medicine can only … -
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Human medicine European public assessment report (EPAR): Seffalair Spiromax
fluticasone propionate, salmeterol xinafoate, Asthma
Date of authorisation: 26/03/2021, Authorised, Last updated: 23/08/2021Seffalair Spiromax Respiratory Tract Diseases Bronchial … propionate Overview Seffalair Spiromax is a medicine used for the … fluticasone. How is Seffalair Spiromax used? The medicine can only … -
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Human medicine European public assessment report (EPAR): BiResp Spiromax
budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive; Asthma
Date of authorisation: 28/04/2014, Revision: 11, Authorised, Last updated: 09/06/2021BiResp Spiromax Lung Diseases, Obstructive Lung … budesonideformoterol Overview BiResp Spiromax is a medicine that contains … taken by inhalation. BiResp Spiromax is also used to relieve the … -
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Human medicine European public assessment report (EPAR): Aerivio Spiromax
salmeterol xinafoate, fluticasone propionate, Pulmonary Disease, Chronic Obstructive; Asthma
Date of authorisation: 18/08/2016, Revision: 2, Withdrawn, Last updated: 15/01/2020Aerivio Spiromax Pulmonary Disease, Chronic … authorisation for Aerivio Spiromax has been withdrawn at the … Summary documents Aerivio Spiromax : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Airexar Spiromax
salmeterol, fluticasone propionate, Pulmonary Disease, Chronic Obstructive; Asthma
Date of authorisation: 18/08/2016, Revision: 2, Withdrawn, Last updated: 02/07/2019Airexar Spiromax Pulmonary Disease, Chronic … authorisation for Airexar Spiromax has been withdrawn at the … Summary documents Airexar Spiromax : EPAR - Summary for the … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 February 2014
CHMP, Last updated: 21/02/2014DuoResp Spiromax … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021
CHMP, Last updated: 23/04/2021Aubagio, BiResp Spiromax, DuoResp Spiromax, Maviret, Nulojix, Opdivo … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May 2015
PRAC, Last updated: 08/05/2015for the procedure BiResp Spiromax: EPAR Budesonide/Formoterol … Budesonide/Formoterol Teva: EPAR DuoResp Spiromax: EPAR Relvar Ellipta: EPAR … EPAR Tysabri: EPAR Vylaer Spiromax: EPAR Tysabri: Withdrawn application … -
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Referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease
beclometasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 28/04/2016, EC decision date: 29/06/2016, Last updated: 15/07/2016Ellipta), 04/07/2016 (BiResp Spiromax, DuoResp Spiromax), 06/07/2016 (Budesonide/Formoterol … Budesonide/Formoterol Teva, Vylaer Spiromax). Inhaled corticosteroids Article-31 … Ellipta), 04/07/2016 (BiResp Spiromax, DuoResp Spiromax), 06/07/2016 (Budesonide/Formoterol … -
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National expert: John Joseph Borg, Medicines Authority (updated)
- Declaration of interests - 80.14 KB | PDF
- Curriculum Vitae - 27.31 KB | PDF
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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): 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 … -
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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 … -
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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 … -
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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 … -
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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 … -
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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 … -
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Human medicine European public assessment report (EPAR): Colobreathe
Colistimethate sodium, Cystic Fibrosis
Date of authorisation: 13/02/2012, Revision: 13, Authorised, Last updated: 13/01/2022changes a 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) 25-29 January 2021
CHMP, Last updated: 01/02/2021Seffalair Spiromax … -
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Human medicine European public assessment report (EPAR): Cayston (updated)
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 … -
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Human medicine European public assessment report (EPAR): Tobi Podhaler
Tobramycin, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 20/07/2011,
, Revision: 19, Authorised, Last updated: 13/05/2022
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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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2016
CHMP, Last updated: 24/06/2016Aerivio Spiromax … -
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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 …