18042 results
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News: EMA issues advice on use of antibody combination (bamlanivimab / etesevimab)
CHMP, Last updated: 05/03/2021 -
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Human medicine European public assessment report (EPAR): Onbevzi
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms
Date of authorisation: 11/01/2021,
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, Authorised, Last updated: 05/03/2021
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Opinion/decision on a Paediatric investigation plan (PIP): hydrocortisone, benzocaine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002739-PIP01-19, Route(s) of administration: Rectal use, Pharmaceutical form(s): Rectal ointment
Decision date: 13/05/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): rosuvastatin calcium, fenofibrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases, Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002743-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 13/05/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 18-(p-[131I]-iodophenyl)octadecyl phosphocholine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002745-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 13/05/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pneumococcal Polyssacharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate, Pneumococcal Polyssacharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-002330-PIP01-18, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Difelikefalin
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-002565-PIP02-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 13/05/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): imatinib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002643-PIP01-19, Route(s) of administration: Nasogastric use, Oral use, Pharmaceutical form(s): Powder for oral solution
Decision date: 13/05/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cyclophosphamide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002644-PIP01-19, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Powder for oral solution
Decision date: 15/05/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tiragolumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002721-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 13/05/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ravagalimab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002617-PIP01-19, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection, Solution for infusion
Decision date: 25/06/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Atropine (sulfate)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Ophthalmology
PIP number: EMEA-002545-PIP01-19, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops
Decision date: 17/06/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated viral vector serotype 8 containing the human RPGR gene
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Ophthalmology
PIP number: EMEA-002601-PIP01-19, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Suspension for injection
Decision date: 17/06/2020, Last updated: 05/03/2021, Compliance check: X -
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News: EMA website briefly unavailable on 8 March 2021
Last updated: 05/03/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Gepotidacin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-002443-PIP02-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Age appropriate oral formulation, Film-coated tablet
Decision date: 16/06/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gepotidacin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-002443-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Age appropriate oral formulation, Film-coated tablet
Decision date: 16/06/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): fidanacogene elaparvovec
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002362-PIP02-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 17/06/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sodium alginate oligosaccharide
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-002321-PIP01-17, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, Capsule, hard
Decision date: 19/06/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Bis-choline tetrathiomolybdate
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-002232-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Coated tablet
Decision date: 19/06/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 4-[4-({4-[({2-[(3S)-2,6-dioxopiperidin-3-yl]-1-oxo-2,3-dihydro-1H-isoindol-4-yl}oxy)methyl]phenyl}methyl)piperazin-1-yl]-3-fluorobenzonitrile
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002714-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pneumococcal polysaccharides individually biotinylated and complexed with a carrier protein (recombinant fusion construct of rhizavidin and Streptococcus pneumoniae derived proteins), 24-valent
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-002641-PIP01-19, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 18/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dexamethasone sodium phosphate encapsulated in human autologous erythrocytes
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-001957-PIP02-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 16/06/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): temozolomide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002634-PIP01-19, Route(s) of administration: Gastric use, Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): 3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5- fluorobenzonitrile
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002619-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Idasanutlin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001489-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Film-coated dispersible tablet
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: X