14107 results
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Referral: Coversyl
perindopril, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/07/2003, EC decision date: 04/12/2003, Last updated: 23/12/2003Commission final decision Overview Perindopril is a specific, competitive … renin-angiotensin-aldosteron system. Perindopril was initially approved in … the benefit/risk ratio of perindopril is considered favourable … -
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Human medicine European public assessment report (EPAR): Tritanrix HepB
Diphtheria toxoid, hepatitis B surface antigen, Bordetella pertussis (inactivated), tetanus toxoid, Hepatitis B; Tetanus; Immunization; Whooping Cough; Diphtheria
Date of authorisation: 19/07/1996, Revision: 15, Withdrawn, Last updated: 07/01/2014diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis … surface antigenBordetella pertussis (inactivated)tetanus toxoiddiphtheria … toxoiddiphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomerata, Lolium perenne, Phleum pratense, Festuca pratensis, Secale cereale
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000845-PIP01-10-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 27/11/2015, Last updated: 06/06/2018, Compliance check: XDactylis glomerata, Lolium perenne, Phleum pratense, Festuca … Dactylis glomerata, Lolium perenne, Phleum pratense, Festuca … Dactylis glomerata, Lolium perenne, Phleum pratense, Festuca … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomarata, Lolium perenne, Phleum pratense, Poa pratensis and Anthoxhantum odoratum (20% each)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000856-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oralmucosal drops
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: XDactylis glomarata, Lolium perenne, Phleum pratense, Poa pratensis … Dactylis glomarata, Lolium perenne, Phle... PDF icon application/pdf … Dactylis glomarata, Lolium perenne, Phleum pratense, Poa pratensis … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense, Secale cereale (20% each)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000864-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oralmucosal drops
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: XFestuca pratensis, Lolium perenne, Phleum pratense, Secale cereale … Festuca pratensis, Lolium perenne, Phleum pratense, Secale cereale … Festuca pratensis, Lolium perenne, Phleum pratense, Secale cereale … -
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Orphan designation: perflubron for: Treatment of respiratory distress syndrome
Date of designation: 09/12/2020, Positive, Last updated: 16/09/2021perflubron Overview On 9 December 2020 … Consultants Limited, Ireland, for perflubron for the treatment of respiratory … opinion on orphan designation Perflubron for the treatment of respiratory … -
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Orphan designation: Perflubron for: Treatment of congenital pulmonary hypoplasia
Date of designation: 13/11/2020, Positive, Last updated: 16/09/2021Perflubron Overview On 13 November 2020 … Consultants Limited, Ireland, for perflubron for the treatment of congenital … medicine expected to work? Perflubron is a liquid that is delivered … -
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Withdrawn application: Imagify
date of withdrawal: 24/07/2014, Initial authorisation, Last updated: 04/02/2015application for Imagify (perflubutane) On 24 July 2014, Acusphere … authorisation for Imagify (perflubutane) intended to be used for … contains the active substance perflubutane. It was to be available as … -
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Orphan designation: Peretinoin for: Treatment of hepatocellular carcinoma
Date of designation: 05/08/2011, Positive, Last updated: 26/07/2018Peretinoin … PSO 003-11 Peretinoin 7 Westferry Circus … opinion on orphan designation Peretinoin for the treatment of hepatocellular … -
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Orphan designation: Perifosine for: Treatment of multiple myeloma
Date of designation: 10/06/2010, Withdrawn, Last updated: 07/02/2014Perifosine Overview Please note that … Zentaris GmbH, Germany, for perifosine for the treatment of multiple … information to show that perifosine might be of significant benefit … -
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Summary of opinion: RenuTend
tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells, opinion date: 16/02/2022, Positive, Last updated: 21/02/2022primed equine allogeneic peripheral blood-derived mesenchymal … primed equine allogeneic peripheral blood-derived mesenchymal … primed equine allogeneic peripheral blood-derived mesenchymal … -
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Referral: Basiron AC and associated names
benzoyl peroxide, Article 13 referrals
Status: European Commission final decision, opinion/position date: 28/03/2019, EC decision date: 04/07/2019, Last updated: 19/07/2019authorisation for Basiron AC (benzoyl peroxide 5% and 10% gel) in the EU … benzoyl peroxide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Perflubutane
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Cardiovascular diseases
PIP number: Perflubutane, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Lyophilisate for suspension for injection
Decision date: 28/11/2008, Last updated: 29/01/2009, Compliance check: XPerflubutane Cardiovascular diseases … Key facts Perflubutane Cardiovascular diseasesP/106 … Cardiovascular diseasesP/106/2008Perflubutane Lyophilisate for suspension … -
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Opinion/decision on a Paediatric investigation plan (PIP): Perflubutane
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Diagnostic
PIP number: EMEA-000194-PIP03-10, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for suspension for injection
Decision date: 18/05/2011, Last updated: 09/06/2011, Compliance check: XKey facts Perflubutane DiagnosticP/116/2011EMEA-000194-PIP03-10 … Visualisation of myocardial perfusion for diagnostic purposes Intravenous … granting of a waiver for perflubutane (EMEA-000194-PIP03-10) PDF … -
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Opinion/decision on a Paediatric investigation plan (PIP): Aqueous extract of grass pollen from Dactylis glomerata, Festuca pratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa pratensis
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: Aqueous extract of grass pollen from Dactylis glomerata, Festuca pratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa pratensis, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Solution for sublingual use
Decision date: 20/07/2009, Last updated: 16/09/2009, Compliance check: Xpratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa prate … pratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa pratensis … pratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa pratensis … -
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Human medicine European public assessment report (EPAR): Hexacima (updated)
hepatitis B surface antigen, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett), Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 27, Authorised, Last updated: 06/01/2023horised diphtheria, tetanus, pertussis (acellular, component), hepatitis … from diphtheria, tetanus, pertussis and Haemophilus influenzae … by infection of a wound); pertussis (whooping cough); hepatitis … -
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Human medicine European public assessment report (EPAR): Pergoveris
follitropin alfa, lutropin alfa, Infertility, Female
Date of authorisation: 25/06/2007, Revision: 14, Authorised, Last updated: 17/08/2022Pergoveris Female Urogenital Diseases … assessment report (EPAR) for Pergoveris. It explains how the Agency … practical advice on how to use Pergoveris. For practical information … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis, Secale cereale and Artemisia vulgaris
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000851-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: XFestuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis … Festuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis … Festuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, perindopril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002091-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/04/2017, Last updated: 29/05/2017, Compliance check: XActive substance amlodipine perindopril Therapeutic area Cardiovascular … specific waiver for amlodipine / perindopril (EMEA-002091-PIP01-16 … specific waiver for amlodipine / perindopril (EMEA-002091-PIP01-16) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): perindopril, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001968-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/11/2016, Last updated: 10/01/2017, Compliance check: XActive substance perindopril amlodipine Therapeutic area … product specific waiver for perindopril / amlodipine (EMEA-001968-PIP01-16) 30 … product specific waiver for perindopril / amlodipine (EMEA-001968-PIP01-16 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Hydrogen Peroxide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Dermatology
PIP number: EMEA-001884-PIP02-15, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 20/05/2016, Last updated: 18/07/2016, Compliance check: XKey facts Hydrogen Peroxide DermatologyP/0143/2016EMEA-001884-PIP02-15 … specific waiver for hydrogen peroxide (EMEA-001884-PIP02-15) PDF … specific waiver for hydrogen peroxide (EMEA-001884-PIP02-15 … -
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Opinion/decision on a Paediatric investigation plan (PIP): perindopril, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001702-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 06/03/2015, Last updated: 24/03/2015, Compliance check: XActive substance perindopril amlodipine Therapeutic area … proposed product-specific waiver Perindopril / amlodipine for treatment … product- specific waiver Perindopril / amlodipine for treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): perindopril, bisoprolol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001497-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 01/09/2014, Last updated: 14/11/2014, Compliance check: XActive substance perindopril bisoprolol Therapeutic area … proposed product-specific waiver Perindopril / bisoprolol for treatment … product-specific waiver Perindopril / bisoprolol for treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Hydrogen Peroxide
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Dermatology
PIP number: EMEA-001884-PIP03-18, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 25/07/2019, Last updated: 12/11/2019, Compliance check: XKey facts Hydrogen Peroxide DermatologyP/0268/2019EMEA-001884-PIP03-18 … of a waiver for hydrogen peroxide (45%) (EMEA-001884-PIP03-18 … Hydrogen Peroxide … -
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Referral: Ergot-derived dopamine agonists
bromocriptine, cabergoline, dihydroergocryptine, lisuride, pergolide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2008, Last updated: 26/06/2008these medicines for long periods, particularly cardiac fibrosis … dihydroergocryptine, lisuride and pergolide. They have been available … medicines are used for long periods. However, two studies published …