1270 results
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Human medicine European public assessment report (EPAR): INOmax
Nitric oxide, Hypertension, Pulmonary; Respiratory Insufficiency
Date of authorisation: 01/08/2001, Revision: 22, Authorised, Last updated: 15/01/2021marketing-authorisation holder is Linde Healthcare AB. The marketing … marketing authorisation holder is Linde Healthcare AB. The marketing … -
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Human medicine European public assessment report (EPAR): Sixmo (updated)
Buprenorphine hydrochloride, Opioid-Related Disorders
Date of authorisation: 19/06/2019,
, Revision: 4, Authorised, Last updated: 20/02/2023
and who are also receiving medical, social and psychological … buprenorphine, within a framework of medical, social and psychological … -
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Opinion/decision on a Paediatric investigation plan (PIP): Amikacin sulfate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000525-PIP01-08-M07, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Nebuliser suspension
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: XNetherlands B.V. E-mail: medicalinformation@insmed.com Tel: +1 908 977 9900 PM … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fluocinolone acetonide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-000801-PIP03-16-M01, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Intravitreal implant in applicator
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: X44 (0)8001488274 E-mail: medicalinformation@alimerasciences.com Decision type PM: decision … -
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Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, tezacaftor, ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001640-PIP01-14-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 30/09/2021, Last updated: 12/01/2023, Compliance check: XIreland) Limited E-mail: medicalinfo@vrtx.com Tel: +1 877 634 8789 PM … -
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Third European Medicines Agency-Medicines for Europe bilateral meeting
European Medicines Agency, Amsterdam, the Netherlands, 23/03/2020, Last updated: 10/03/2020Registration closed Contact point Linda Malaguti Follow link linda.malaguti@ema.europa.eu Topics: Medicines … -
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Opinion/decision on a Paediatric investigation plan (PIP): Catumaxomab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002879-PIP01-20, Route(s) of administration: Intraperitoneal use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: Xascites Intraperitoneal use Lindis Biotech GmbH Email: info lindisbiotech.de Tel. +49 8945239600 … application submitted by Lindis Biotech GmbH on 8 September … decision is addressed to Lindis Biotech GmbH, Am Klopferspitz … -
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Opinion/decision on a Paediatric investigation plan (PIP): nivolumab, Relatlimab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002727-PIP01-19-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 17/03/2021, Last updated: 09/03/2023, Compliance check: V, 10/09/2021International Corporation E-mail: medical.information@bms.com Tel. +44 1423 533 610 PM … -
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Opinion/decision on a Paediatric investigation plan (PIP): Orkambi, Lumacaftor, ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001582-PIP01-13-M10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules
Decision date: 22/12/2020, Last updated: 27/09/2021, Compliance check: XTel. +1 8776348789 E-mail: medicalinfo@vrtx.com Decision type PM: decision … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lonapegsomatropin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002692-PIP01-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 15/07/2020, Last updated: 16/09/2021, Compliance check: X, 04/09/2020Endocrinology Division A/S E-mail: MedicalAffairs@ascendispharma.com Tel. +45 70222244 P: decision … -
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Orphan designation: 1-((2S,4S)-2-((((S)-(4-bromophenoxy)(((S)-1-oxo-1-(((S)-pentan-2-yl)oxy)propan-2-yl)amino)phosphoryl)oxy)methyl)-1,3-dioxolan-4-yl)-2-oxo-1,2-dihydropyrimidin-4-aminium chloride for: Treatment of hepatocellular carcinoma
Date of designation: 04/06/2020, Positive, Last updated: 19/08/2020Tel. +46854683120 E-mail: Linda.Basse@medivir.com … -
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Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000335-PIP01-08-M14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules in sachet
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: XTel. +1 8776348789 E-mail: medicalinfo@vrtx.com Decision type PM: decision … -
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Opinion/decision on a Paediatric investigation plan (PIP): Opdivo, nivolumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001407-PIP01-12-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 05/11/2020, Last updated: 10/03/2023, Compliance check: V, 21/01/2022Squibb Pharma EEIG E-mail: medical.information@bms.com Tel. +44 1423 533 610 PM … -
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Opinion/decision on a Paediatric investigation plan (PIP): Cendakimab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002640-PIP01-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/09/2021, Last updated: 02/12/2022, Compliance check: XSquibb Pharma EEIG E-mail: medical.information@bms.com Tel: +44 1423 53 3610 P … -
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Opinion/decision on a Paediatric investigation plan (PIP): 2-[[2-ethyl-6-[4-[2-(3-hydroxyazetidin-1-yl)-2-oxoethyl]piperazin-1-yl]-8-methylimidazo[1,2-a]pyridin-3-yl](methyl)amino]-4-(4-fluorophenyl)-1,3-thiazole-5-carbonitrile
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-002333-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate formulation
Decision date: 18/04/2020, Last updated: 29/11/2021, Compliance check: XTel. ++32 15342900 E-mail: medicalinfo@glpg.com Decision type P: decision … Telephone: +32 1534 2900 Email: medicalinfo@glpg.com Official address … -
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European Medicines Agency and EuropaBio annual bilateral meeting 2022
Online, 10:00 - 12:00 Amsterdam time (CEST), 07/06/2022, Last updated: 07/06/2022linda.malaguti@ema.europa.eu … -
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European Medicines Agency and EuropaBio annual bilateral meeting 2020
Virtual meeting, 26/05/2020, Last updated: 20/05/2020linda.malaguti@ema.europa.eu … -
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Opinion/decision on a Paediatric investigation plan (PIP): birch bark
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-001299-PIP03-17-M01, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Gel
Decision date: 22/10/2020, Last updated: 23/07/2021, Compliance check: XResearch Limited E-mail: medicalmonitor@amrytpharma.com Tel: +353 1 6694606 PM: decision … -
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Opinion/decision on a Paediatric investigation plan (PIP): Brensocatib
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-002905-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/10/2021, Last updated: 22/03/2022, Compliance check: XNetherlands B.V. E-mail: medicalinformation@insmed.com Telephone: +1 9089474303 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Zeposia, Ozanimod (hydrochloride)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001710-PIP03-17-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 08/06/2021, Last updated: 02/12/2022, Compliance check: XSquibb Pharma EEIG E-mail: medical.information@bms.com Tel: +44 1423 53 3610 PM … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tirasemtiv
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-001594-PIP02-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 08/08/2014, Last updated: 22/08/2014, Compliance check: XGroup United States E-mail: medicalaffairs@cytokinetics.com Tel. +1 650 6243000 Decision … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lumacaftor
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001173-PIP01-11-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 19/12/2013, Last updated: 04/02/2014, Compliance check: XTel. +1 8776348789 E-mail: medicalinfo@vrtx.com PM: decision on the application … -
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Orphan designation: Ganaxolone for: Treatment of tuberous sclerosis
Date of designation: 15/10/2021, Positive, Last updated: 20/01/2022Tel. +44 14848014670 E-mail: Medicalaffairs@marinuspharma.com … -
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Opinion/decision on a Paediatric investigation plan (PIP): ivacaftor / tezacaftor/ potassium (benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl)cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide (VX-659)
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- 002191-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 22/03/2019, Last updated: 24/06/2019, Compliance check: XTel. +1 8776348789 E-mail: medicalinfo@vrtx.com P: decision agreeing on a … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vonoprazan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology; Infectious diseases
PIP number: EMEA-002703-PIP01-19, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Tablet, Dispersible tablet, Age-appropriate dosage form
Decision date: 04/12/2020, Last updated: 22/09/2021, Compliance check: XPharmaceuticals, Inc. E-mail: medicalinformation@phathompharma.com Tel: +1 8777428466 Decision …