For help on how to get the results you want, see our search tips.
1033 results
Medicine
Orphan designations Remove Orphan designations filter
Paediatric investigation plans Remove Paediatric investigation plans filter
Summaries of opinion Remove Summaries of opinion filter
Direct healthcare professional communication Remove Direct healthcare professional communication filter
PIP decision type
RPM: decision refers to a refusal on the application for modification of an agreed PIP Remove RPM: decision refers to a refusal on the application for modification of an agreed PIP filter
W: decision granting a waiver in all age groups for all conditions or indications Remove W: decision granting a waiver in all age groups for all conditions or indications filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Zynteglo, betibeglogene autotemcel (updated)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001665-PIP01-14-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 13/05/2022, Last updated: 16/05/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Modified allergen extract of birch pollen
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000932-PIP01-10-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-001501-PIP08-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 17/03/2021, Last updated: 28/03/2023, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus, Dermatophagoides farinae
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001014-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
Decision date: 22/03/2019, Last updated: 13/12/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001016-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
Decision date: 22/03/2019, Last updated: 13/12/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): birch pollen, alder pollen
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001012-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Coated tablet
Decision date: 22/03/2019, Last updated: 13/12/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Recombinant porcine factor VIII, B-domain deleted
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000753-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection, Powder and solvent for solution for injection
Decision date: 24/02/2012, Last updated: 10/10/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): In vitro expanded autologous human articular chondrocytes
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002217-PIP01-17-M02, Route(s) of administration: Intraarticular use, Pharmaceutical form(s): Implant
Decision date: 12/08/2021, Last updated: 01/09/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Elafibranor
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001857-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 12/08/2020, Last updated: 10/08/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tislelizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002480-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 17/04/2019, Last updated: 27/06/2022, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002153-PIP01-17-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, pre-dispensed
Decision date: 14/02/2020, Last updated: 10/12/2021, Compliance check: X -
List item
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: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Reagila, Cariprazine (hydrochloride)
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001652-PIP01-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 17/03/2021, Last updated: 26/11/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): idecabtagene vicleucel
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002369-PIP01-18-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 19/02/2021, Last updated: 08/10/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Lartruvo, Olaratumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001760-PIP01-15-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/03/2019, Last updated: 08/10/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): (1R,2R,3S,4S,5R,6S)-cyclohexane-1,2,3,4,5,6-hexayl-hexakis (dihydrogen phosphate)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002854-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 01/12/2020, Last updated: 22/09/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Veklury, remdesivir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002826-PIP01-20-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Powder for concentrate for solution for infusion
Decision date: 09/08/2021, Last updated: 19/08/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Linerixibat
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002800-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 09/09/2020, Last updated: 01/07/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Anti-neonatal Fc receptor human monoclonal antibody
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002559-PIP01-19, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 16/08/2019, Last updated: 01/07/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Viekirax, Ombitasvir, paritaprevir, ritonavir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001440-PIP01-13-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 12/08/2020, Last updated: 30/06/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Ariclaim, duloxetine hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Uro-nephrology
PIP number: EMEA-000420-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Gastro-resistant capsule
Decision date: 17/11/2010, Last updated: 22/06/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Victrelis, Boceprevir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-000583-PIP01-09-M08, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules, Capsule, hard
Decision date: 17/04/2020, Last updated: 05/03/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Varuby, rolapitant
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001768-PIP02-15-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral dosage form
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): belantamab mafodotin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002468-PIP04-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 11/09/2020, Last updated: 19/02/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): ambrisentan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002030-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/01/2017, Last updated: 19/02/2021, Compliance check: X