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238 results
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Opinion/decision on a Paediatric investigation plan (PIP): Evarrest, human fibrinogen, human thrombin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001149-PIP01-11-M06, Route(s) of administration: Epilesional use, Pharmaceutical form(s): Solution for sealant, Sealant matrix
Decision date: 27/01/2021, Last updated: 29/09/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Coagadex, Human coagulation factor X
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000971-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: V, 26/01/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Fluad Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001715-PIP01-14-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 29/01/2020, Last updated: 01/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Iblias, octocog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001064-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 16/03/2018, Last updated: 06/06/2018, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Praxbind, idarucizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001438-PIP01-13-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 17/04/2019, Last updated: 16/09/2021, Compliance check: V, 24/07/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Reblozyl, Luspatercept
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001521-PIP01-13-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recarbrio, relebactam (MK-7655A), cilastatin sodium, imipenem monohydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001809-PIP01-15-M02, Route(s) of administration: Parenteral use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 24/07/2020, Last updated: 29/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Spherox, spheroids of human autologous matrix-associated chondrocytes
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001264-PIP01-12-M02, Route(s) of administration: Intra-articular use, Pharmaceutical form(s): Implantation suspension
Decision date: 15/06/2018, Last updated: 16/09/2021, Compliance check: V, 24/07/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Cinqaero, Reslizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001202-PIP02-13-M04, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 12/08/2020, Last updated: 28/06/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Strensiq, asfotase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000987-PIP01-10-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/05/2019, Last updated: 21/09/2021, Compliance check: V, 18/10/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Vimizim, Recombinant human N-acetylgalactosamine-6-sulfatase (BMN110)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000973-PIP01-10-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 30/03/2015, Last updated: 06/05/2015, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xofigo, radium (223Ra) dichloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001986-PIP01-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 03/07/2017, Last updated: 24/07/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Evenity, Romosozumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001075-PIP04-15-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/05/2020, Last updated: 16/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xerava, eravacycline
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001555-PIP01-13-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 15/07/2020, Last updated: 01/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Sirturo, bedaquiline fumarate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000912-PIP01-10-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules
Decision date: 09/09/2020, Last updated: 08/07/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Blincyto, blinatumomab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000574-PIP02-12-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
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): GHRYVELIN (previously Macimorelin Aeterna Zentaris), Macimorelin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001988-PIP01-16-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral solution
Decision date: 06/04/2020, Last updated: 08/03/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Biktarvy, bictegravir, emtricitabine, tenofovir alafenamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001766-PIP01-15-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Film-coated tablet
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Isentress, Raltegravir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000279-PIP01-08-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Chewable tablet, Granules for oral suspension
Decision date: 15/06/2016, Last updated: 02/03/2018, Compliance check: V, 19/06/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Zolgensma, onasemnogene abeparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002168-PIP01-17-M03, Route(s) of administration: Intravenous use, Intrathecal use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 09/09/2020, Last updated: 02/07/2021, Compliance check: X -
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Direct healthcare professional communication (DHPC): Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy
Active substance: onasemnogene abeparvovec, DHPC type: Type II variation, Last updated: 18/03/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Emgality, Galcanezumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001860-PIP03-16-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/04/2020, Last updated: 08/03/2021, Compliance check: X -
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Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Batch-specific product recall
Active substance: alpha1-proteinase inhibitor (human), DHPC type: Quality defect, Last updated: 12/02/2021 -
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Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Sterility issue with the infusion device co-packed with Respreeza 4.000 mg and 5.000 mg
Active substance: Human alpha1-proteinase inhibitor, DHPC type: Medicine shortage, Last updated: 26/03/2021 -
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet
Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020