Search Filters:

The items contained in the list are being used to filter the search results. Click them to remove them from the search filter.
Displaying 1 - 20 of 72
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100487-PIP01-22
  • exebacase
  • Treatment of Staphylococcus aureus bacteraemia
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100473-PIP01-22
  • Recombinant COVID-19 subunit nanoparticle
  • Prevention of coronavirus disease 2019 (COVID-19)
  • not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100332-PIP01-21
  • sotatercept
  • Treatment of pulmonary arterial hypertension
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 27/09/2022
MHRA-100382-PIP01-21
  • RAVULIZUMAB
  • Treatment of myasthenia gravis
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(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-100218-PIP01-21
  • DUPILUMAB
  • Treatment of chronic spontaneous urticaria
  • Dupixent
  • Dupixent
  • Dermatology
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-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-100141-PIP01-21
  • BENRALIZUMAB
  • Treatment of Eosinophilic Granulomatosis with Polyangitis (EGPA)
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • Pneumology - Allergology
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-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-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-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-100448-PIP01-22
  • RUXOLITINIB PHOSPHATE
  • Treatment of vitiligo
  • OPZELURA
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100312-PIP01-21
  • Ritlectinib
  • Treatment of alopecia areata
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted 29/07/2022
MHRA-100330-PIP01-21
  • Autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) genetically modified with the lentiviral vector IDUA LVV, encoding for the human α-L-iduronidase (IDUA) gene (OTL-203)
  • Treatment of Mucopolysaccharidosis type I, Hurler syndrome (MPS-IH)
  • Other: Metabolic disorders
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100315-PIP01-21
  • Brensocatib
  • Treatment of non‐cystic fibrosis bronchiectasis
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100364-PIP01-21
  • Respiratory Syncytial Virus (RSV) PreF3 recombinant Fusion protein/AS01
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100304-PIP01-21
  • rozibafusp alfa
  • Treatment of systemic lupus erythematosus (SLE)
  • Not available at present
  • Immunology -Rheumatology-Transplantation
  • Other: Inflammation-Rheumatology SLE
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022
MHRA-100305-PIP01-21
  • Single chain urokinase plasminogen activator (scuPA)
  • Treatment of pleural effusion
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 29/07/2022