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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100450-PIP01-22-M01 (update)
  • ALPELISIB
  • PIK3CA Related Overgrowth Spectrum (PROS)
  • Piqray
  • Piqray
  • Other: Congenital, Hereditary, Neonatal Disease and Abnormalities
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 29/07/2022
MHRA-100727-PIP01-22-M01 (update)
  • ALPELISIB
  • Treatment of PIK3CA related overgrowth spectrum
  • Vijoice
  • Piqray
  • Vijoice
  • Other: Congenital, Hereditary, Neonatal Disease and Abnormalities
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100806-PIP01-22
  • ALPELISIB
  • Treatment of ovarian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Fallopian cancer (excluding rhabdomyosarcoma and germ cell tumours)
  • Treatment of Peritoneal cancer (excluding blastomas and sarcomas).
  • Piqray
  • Piqray
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 24/08/2023
MHRA-100494-PIP01-22-M01 (update)
  • NIVOLUMAB
  • Malignant neoplasms of lymphoid tissue
  • Malignant neoplasms of the central nervous system
  • OPDIVO
  • OPDIVO
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100761-PIP01-22-M01 (update)
  • NIVOLUMAB
  • relatlimab
  • Treatment of melanoma
  • Opdualag
  • Opdualag
  • Opdualag
  • Opdualag
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 25/05/2023
MHRA-100122-PIP01-21
  • olpasiran
  • Prevention of cardiovascular events
  • Cardiovascular Diseases
 W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100190-PIP01-21
  • Ordesekimab
  • Treatment of coeliac disease
  • Gastroenterology-Hepatology
  • Immunology -Rheumatology-Transplantation
 W: decision granting a waiver in all age groups for the listed condition(s). No 29/07/2022
MHRA-100521-PIP01-22-M01 (update)
  • Evinacumab
  • Treatment of elevated cholesterol
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 29/07/2022
MHRA-100521-PIP01-22-M02 (update)
  • Evinacumab
  • Treatment of elevated cholesterol
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Evkeeza
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100525-PIP01-22-M01 (update)
  • TILDRAKIZUMAB
  • Treatment of psoriasis
  • Ilumetri 100 mg solution for injection in pre-filled syringe
  • Ilumetri 100 mg solution for injection in pre-filled syringe
  • ILUMYA
  • ILUMYA
  • ILUMYA
  • Ilumetri 100 mg solution for injection in pre-filled syringe
  • Ilumetri
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 29/07/2022
MHRA-100409-PIP01-21
  • autologous dendritic cells pulsed with autologous tumour cell lysate
  • Treatment of high grade glioma
  • Oncology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100409-PIP01-21-M01 (update)
  • autologous dendritic cells pulsed with autologous tumour cell lysate
  • Treatment of high grade glioma
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100115-PIP01-21
  • Dersimelagon
  • Treatment of erythropoietic protoporphyria
  • Treatment of X-linked protoporphyria
  • Not available at present
  • Dermatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100105-PIP01-21
  • ALPRAZOLAM
  • Treatment of epileptic seizures
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100151-PIP01-21
  • CANNABIDIOL
  • Treatment of epilepsy with myoclonic-atonic seizures (EMAS)
  • Epidyolex
  • Epidyolex
  • Epidyolex
  • Epidiolex
  • Epidyolex
  • Epidyolex
  • Epidiolex
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100178-PIP01-21
  • DTX401 (a nonreplicating, recombinant adeno-associated virus serotype 8 vector that contains a codon-optimized, wild-type human glucose-6-phosphatase (G6PC) gene)
  • Treatment of glycogen storage disease type 1a (GSDIa)
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100226-PIP01-21
  • Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; ABBV-154
  • Treatment of chronic idiopathic arthritis (rheumatoid, psoriatic, JIA, ankylosing spondylitis)
  • Immunology -Rheumatology-Transplantation
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100295-PIP01-21
  • Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; (ABBV-154).
  • Treatment of polymyalgia rheumatica
  • Immunology -Rheumatology-Transplantation
 W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
MHRA-100335-PIP01-21
  • erdafitinib
  • Malignant neoplasms (except urothelial carcinoma, haematopoietic and lymphoid tissue)
  • BALVERSA
  • BALVERSA
  • ERFANDEL
  • BALVERSA
  • Oncology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100374-PIP01-21
  • Adeno-associated virus serotype 1 vector containing the human progranulin GRN gene
  • Treatment of frontotemporal dementia
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No 27/09/2022
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