356 results
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Opinion/decision on a Paediatric investigation plan (PIP): Latuda, Lurasidone hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001230-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2019, Last updated: 21/09/2021, Compliance check: V, 11/12/2019AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.p.A … Tel. +3906780531 E-mail: angeliniregulatoryaffairs@angelinipharma.com Decision type PM: decision … -
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Opinion/decision on a Paediatric investigation plan (PIP): benzydamine (hydrochloride), econazole nitrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002143-PIP01-17, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Pessary
Decision date: 30/06/2017, Last updated: 25/07/2017, Compliance check: XAziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A … 0691045249 E-mail: ma.gatto@angelini.it ; m.gatto angelini.it Decision type W: decision … Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A … -
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Opinion/decision on a Paediatric investigation plan (PIP): Trazodone (hydrochloride), gabapentin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002263-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: XAziende Chimiche Riunite Angelini Francesco - A.C.R.A.F … 0691045249 E-mail: m.gatto@angelini.it W: decision granting … Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F … -
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Opinion/decision on a Paediatric investigation plan (PIP): Trazodone (hydrochloride)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-002142-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: XAziende Chimiche Riunite Angelini Francesco - A.C.R.A.F - S.p.A … 0691045249 E-mail: m.gatto@angelini.it P: decision agreeing on … Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F … -
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Human medicine European public assessment report (EPAR): Ontozry
cenobamate, Epilepsy
Date of authorisation: 26/03/2021,
, Revision: 4, Authorised, Last updated: 08/09/2022
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Human medicine European public assessment report (EPAR): Latuda
lurasidone, Schizophrenia
Date of authorisation: 21/03/2014, Revision: 25, Authorised, Last updated: 17/03/2022Aziende Chimiche Riunite Angelini Francesco S.p.A. Revision … -
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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): 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 … -
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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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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 … -
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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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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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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: 14/04/2023
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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National expert: Nigel Olisa, European Medicines Agency (updated)
- Declaration of interests - 40.46 KB | PDF
- Curriculum Vitae - 22.67 KB | PDF
Ingelheim, Teva, Servier, Angelini, Compass Pathways All supporting … Ingelheim, Teva, Servier, Angelini, Compass Pathways All supporting … -
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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 … -
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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 …