169 results
Keyword Epinephrine Remove keyword
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Withdrawn application: Neffy
epinephrine, date of withdrawal: 04/04/2022, Initial authorisation, Last updated: 20/05/2022epinephrine Overview ARS Pharmaceuticals … International non-proprietary name: epinephrine Procedure No. EMEA/H/C/005584/0000 Note Assessment … Neffy Neffy epinephrine epinephrine … -
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Referral: Adrenaline auto-injectors
adrenaline (epinephrine), Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/06/2015, EC decision date: 14/08/2015, Last updated: 26/08/2015al. (2013). "Predictors of epinephrine autoinjector needle length … randomized maternal evaluation of epinephrine autoinjection devices." Pediatr … E., X. Gu, et al. (2001). "Epinephrine absorption in adults: intramuscular … -
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Opinion/decision on a Paediatric investigation plan (PIP): Adrenaline (epinephrine)
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-002749-PIP01-19, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray, solution
Decision date: 05/11/2020, Last updated: 09/09/2021, Compliance check: XKey facts Adrenaline (epinephrine) Pneumology-allergologyP/0431/2020EMEA-002749-PIP01-19 … a waiver for adrenaline (epinephrine) (EMEA-002749-PIP01-19) PDF … a waiver for adrenaline (epinephrine) (EMEA-002749-PIP01-19) in … -
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Press release: Better training tools recommended to support patients using adrenaline auto-injectors
CHMP, Last updated: 26/06/2015al. (2013). "Predictors of epinephrine autoinjector needle length … randomized maternal evaluation of epinephrine autoinjection devices." Pediatr … E., X. Gu, et al. (2001). "Epinephrine absorption in adults: intramuscular … -
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National expert: Nadine Petitpain, Ministry for Health (updated)
- Declaration of interests - 81.19 KB | PDF
- Curriculum Vitae - 25.97 KB | PDF
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National expert: Rolf Gedeborg, Medical Products Agency (updated)
- Declaration of interests - 80.21 KB | PDF
- Curriculum Vitae - 34.07 KB | PDF
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National expert: Jose Manuel Zubeldia, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 24.34 KB | PDF
Oct;4(10):728-739. Is Self-Injectable Epinephrine Being Used by Children with … May-Jun;7(5):1599-1609. When is epinephrine prescribed for anaphylaxis … -
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Referral: Septanest and associated names
articaine (hydrochloride), adrenaline (tartrate), Article 30 referrals
Status: European Commission final decision, opinion/position date: 28/06/2018, EC decision date: 28/03/2019, Last updated: 19/06/2019together with adrenaline (epinephrine), which helps prolong articaine’s … -
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Human medicine European public assessment report (EPAR): Palforzia (updated)
defatted powder of Arachis hypogaea L., semen (peanuts), Peanut Hypersensitivity
Date of authorisation: 17/12/2020,
, Revision: 3, Authorised, Last updated: 30/05/2022
Self-injectable adrenaline (epinephrine) must be available to the … -
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Human medicine European public assessment report (EPAR): Nuceiva (updated)
Botulinum toxin type A, Skin Aging
Date of authorisation: 27/09/2019,, Revision: 4, Authorised, Last updated: 10/06/2022
injection of botulinum toxin. Epinephrine (adrenaline) or any other … -
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Human medicine European public assessment report (EPAR): Ganfort (updated)
bimatoprost, timolol, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 19/05/2006, Revision: 22, Authorised, Last updated: 23/06/2022 -
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Human medicine European public assessment report (EPAR): Oncaspar (updated)
pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/01/2016, Revision: 14, Authorised, Last updated: 07/06/2022 -
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Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,
, Revision: 6, Authorised, Last updated: 24/03/2022
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Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,, 
, Revision: 23, Authorised, Last updated: 24/05/2022
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Human medicine European public assessment report (EPAR): Truvelog Mix 30 (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/04/2022,, Authorised, Last updated: 15/06/2022
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Human medicine European public assessment report (EPAR): Naglazyme
galsulfase, Mucopolysaccharidosis VI
Date of authorisation: 23/01/2006,, , Revision: 19, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): Insulin aspart Sanofi
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020,
, Revision: 3, Authorised, Last updated: 27/01/2022
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Human medicine European public assessment report (EPAR): Insuman
insulin human, Diabetes Mellitus
Date of authorisation: 21/02/1997, Revision: 31, Authorised, Last updated: 08/12/2021 -
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Human medicine European public assessment report (EPAR): Firazyr
icatibant, Angioedemas, Hereditary
Date of authorisation: 11/07/2008, Revision: 19, Authorised, Last updated: 11/01/2022 -
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Human medicine European public assessment report (EPAR): Regkirona (updated)
Regdanvimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 3, Authorised, Last updated: 30/05/2022
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Human medicine European public assessment report (EPAR): Rapiscan
regadenoson, Myocardial Perfusion Imaging
Date of authorisation: 06/09/2010, Revision: 14, Authorised, Last updated: 13/01/2022 -
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Human medicine European public assessment report (EPAR): Riximyo (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 15/06/2017,, Revision: 10, Authorised, Last updated: 13/06/2022
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National expert: Martina Weise, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 80.21 KB | PDF
- Curriculum Vitae - 24.66 KB | PDF
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Human medicine European public assessment report (EPAR): Rixathon (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 15/06/2017,, Revision: 8, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Ruxience
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell; Arthritis, Rheumatoid; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 01/04/2020,, , Revision: 7, Authorised, Last updated: 21/03/2022