For help on how to get the results you want, see our search tips.
22 results
Categories
Human Remove Human filter
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): zofenopril, nebivolol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002593-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Equine immunoglobulin F(ab')2 fragments targeting Shiga toxin
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-002444-PIP02-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 10/09/2020, Last updated: 23/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): levonorgestrel
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-002474-PIP02-18, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal delivery system
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Trifarotene
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-001492-PIP02-18, Route(s) of administration: Topical use, Pharmaceutical form(s): Cream
Decision date: 11/09/2020, Last updated: 20/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): PEGylated-fibroblast growth factor 21 (BMS-986036)
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-002448-PIP01-18, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002569-PIP04-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 11/09/2020, Last updated: 25/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Baloxavir marboxil
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-002440-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension
Decision date: 02/09/2020, Last updated: 23/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Infigratinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002594-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): fosmetpantotenate
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-002036-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension, Granules for oral suspension
Decision date: 11/09/2020, Last updated: 20/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tirzepatide
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-002360-PIP01-18, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 10/09/2020, Last updated: 23/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): pegvorhyaluronidase alpha
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-001883-PIP03-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 11/09/2020, Last updated: 20/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): liposomal ciclosporin A (L-CsA)
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-002344-PIP02-18, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Powder for nebuliser solution
Decision date: 11/09/2020, Last updated: 23/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): dostarlimab
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-002463-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Botulinum toxin type A
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002628-PIP01-19, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Eptinezumab
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-002243-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 11/09/2020, Last updated: 23/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002569-PIP04-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 11/09/2020, Last updated: 25/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Fexapotide (friflutate)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Uro-nephrology
PIP number: EMEA-002598-PIP01-19, Route(s) of administration: Intraprostatic use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 11/09/2020, Last updated: 25/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): birch bark
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-001299-PIP03-17, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Gel
Decision date: 11/09/2020, Last updated: 20/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): mitapivat
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-002684-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Film-coated tablet
Decision date: 09/09/2020, Last updated: 16/02/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): belantamab mafodotin (updated)
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): Zejula, Niraparib (tosilate monohydrate)
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-002268-PIP02-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate oral liquid dosage form
Decision date: 10/09/2020, Last updated: 23/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Atropine (sulfate), Obidoxime (chloride)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002570-PIP01-19, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: X