6507 results
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Human medicine European public assessment report (EPAR): Rivastigmine 3M Health Care Ltd
rivastigmine, Alzheimer Disease
Date of authorisation: 03/04/2014,
, Revision: 1, Withdrawn, Last updated: 18/09/2014
Rivastigmine 3M Health Care Ltd Alzheimer Disease … for Rivastigmine 3M Health Care Ltd has been withdrawn at … documents Rivastigmine 3M Health Care Ltd : EPAR - Summary for … -
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Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of designation: 16/01/2014, Positive, Last updated: 23/01/2014Lactobacillus acidophilus and Bifidobacterium bifidum … Italy, for Lactobacillus acidophilus and Bifidobacterium bifidum … expected to work? Lactobacillus acidophilus and Bifidobacterium bifidum … -
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Opinion/decision on a Paediatric investigation plan (PIP): 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-001354-PIP01-12, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal gel
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: X2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … 2,6-bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2 … 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … -
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Human medicine European public assessment report (EPAR): Sibnayal
Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular
Date of authorisation: 30/04/2021, Revision: 1, Authorised, Last updated: 26/04/2022Diseases Acid-Base Imbalance Acidosis Acidosis, Renal Tubular … with distal renal tubular acidosis (dRTA), a disease in which … reported with Sibnayal are carefully evaluated and any necessary … -
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Press release: Updated advice on body fat changes and lactic acidosis with HIV medicines
CHMP, Last updated: 23/10/2015body fat changes and lactic acidosis with HIV medicines … body fat changes and lactic acidosis with medicines for the treatment … require a warning about lactic acidosis. … -
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Careers
Last updated: 24/06/2019Careers … A career at the European Medicines …
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National expert: Eleanor Carey, Health Products Regulatory Authority (updated)
- Declaration of interests - 80.36 KB | PDF
- Curriculum Vitae - 16.25 KB | PDF
Eleanor Carey … Eleanor Carey … Vitae PERSONAL INFORMATION Eleanor Carey WORK EXPERIENCE January … -
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Patients and carers
Last updated: 16/12/2020Patients and carers … Patients and carers …
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National expert: Violaine Closson Carella, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 80.14 KB | PDF
- Curriculum Vitae - 18.71 KB | PDF
Violaine Closson Carella … Violaine Closson Carella … INFORMATION Violaine Closson Carella WORK EXPERIENCE June 2016 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Mecasermin rinfabate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-000534-PIP03-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 28/02/2020, Last updated: 05/04/2022, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/0066/2020 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Dipalmitoylphosphatidylcholine, 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol sodium salt, synthetic surfactant protein C analogue, synthetic surfactant protein B analogue (CHF 5633)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-001780-PIP01-15, Route(s) of administration: Endotracheopulmonary use, Pharmaceutical form(s): Endotracheopulmonary instillation, suspension
Decision date: 21/12/2016, Last updated: 10/12/2021, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/0363/2016 … -
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Opinion/decision on a Paediatric investigation plan (PIP): octenidine dihydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-001384-PIP01-12, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 21/12/2016, Last updated: 29/11/2021, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/0360/2016 … -
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Opinion/decision on a Paediatric investigation plan (PIP): hydrocortisone (hemisuccinate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-002305-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 09/09/2020, Last updated: 02/07/2021, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/0358/2020 … -
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Opinion/decision on a Paediatric investigation plan (PIP): 2-iminobiotin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-001070-PIP01-10-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 15/05/2020, Last updated: 16/03/2021, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/0192/2020 … -
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Opinion/decision on a Paediatric investigation plan (PIP): isoflurane
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-002320-PIP01-17-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation vapour, liquid
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/0190/2020 … to a paediatric intensive care unit or with a planned ICU … -
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Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-001553-PIP01-13-M02, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Nebuliser solution
Decision date: 07/12/2018, Last updated: 20/02/2019, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/0367/2018 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Azithromycin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-001298-PIP01-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Age-appropriate dosage form for parenteral use
Decision date: 27/02/2013, Last updated: 23/04/2013, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/0037/2013 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Synagis, palivizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-001309-PIP01-12, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection, Powder and solvent for solution for injection
Decision date: 30/04/2013, Last updated: 31/05/2013, Compliance check: V, 09/08/2013atology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/0111/2013 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Morphine (hydrochloride)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-000711-PIP01-09, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 20/01/2012, Last updated: 24/02/2012, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/0001/2012 … -
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Opinion/decision on a Paediatric investigation plan (PIP): budesonide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-001120-PIP01-10, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Pressurised inhalation, solution
Decision date: 30/11/2011, Last updated: 21/12/2011, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/285/2011 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fentanyl citrate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-000712-PIP01-09, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 23/11/2010, Last updated: 20/12/2010, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/231/2010 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pagibaximab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-000608-PIP01-09, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 29/10/2010, Last updated: 25/11/2010, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/212/2010 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Motavizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-000352-PIP01-08-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 27/10/2010, Last updated: 24/11/2010, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/199/2010 … -
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Opinion/decision on a Paediatric investigation plan (PIP): The whole range of unmanipulated autologous mononuclear cells derived from human umbilical cord blood (Hau-UCB-mnc)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-001799-PIP03-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Suspension for infusion
Decision date: 25/09/2020, Last updated: 06/07/2021, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/0385/2020 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Retinol (Vitamin A)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-002790-PIP01-20, Route(s) of administration: Intramuscular use, Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 28/01/2021, Last updated: 06/10/2021, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/0023/2021 …