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Displaying 141 - 160 of 669
PIPS Search Results
PIP Number Active Substance Sort ascending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100820-PIP01-22
  • Tirzepatide
  • Treatment of obesity
  • Mounjaro
  • Other: Obesity, Overweight
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100799-PIP01-22-M01 (update)
  • BEDAQUILINE FUMARATE
  • Treatment of multi-drug resistant tuberculosis
  • Sirturo
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100701-PIP01-22-M01 (update)
  • Outer Membrane Vesicles (OMV) from N. meningitidis Strain NZ 98/254
  • Recombinant Neisseria meningitis group B Protein 936-741
  • Meningococcal group W-135 oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Meningococcal group A oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Meningococcal group C oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Recombinant Neisseria meningitis group B Protein 287- 953
  • Recombinant Neisseria meningitis group B Protein 961c
  • Meningococcal group Y oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Prevention of meningococcal meningitis
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100645-PIP01-22-M01 (update)
  • AMIKACIN SULFATE
  • Treatment of Pseudomonas aeruginosa lung infection/colonisation in cystic fibrosis patients
  • Treatment of non-tuberculous mycobacterial lung infection
  • Arikayce
  • Arikayce
  • Arikayce liposomal
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100805-PIP01-22-M01 (update)
  • ATIDARSAGENE AUTOTEMCEL
  • Treatment of metachromatic leukodystrophy (MLD)
  • Libmeldy
  • Libmeldy
  • Libmeldy
  • Other: Lysosomal storage Disorder
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100544-PIP01-22-M01 (update)
  • sebetralstat
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100544-PIP01-22-M02 (update)
  • sebetralstat
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/01/2024
MHRA-100719-PIP01-22
  • LUTETIUM (177LU) OXODOTREOTIDE
  • Treatment of gastroenteropancreatic neuroendocrine tumours
  • Lutathera 370 MBq/mL solution for infusion
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Lutathera
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023
MHRA-100110-PIP02-22
  • Yellow fever virus, strain vYF-247
  • Prevention of yellow fever disease
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023
MHRA-100737-PIP01-22
  • Clazakizumab
  • Prevention and treatment of rejection of transplanted kidney
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023
MHRA-100684-PIP01-22
  • Clazakizumab
  • Prevention of cardiovascular events in patients with atherosclerosis
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100371-PIP01-21
  • Ex vivo expanded autologous human keratinocytes containing epidermal stem cells genetically modified with a gamma-retroviral (RV) vector expressing the full-length LAMB3 cDNA
  • Treatment of Junctional Epidermolysis Bullosa (JEB)
  • HOLOGENE 5
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023
MHRA-100792-PIP01-22
  • OBINUTUZUMAB
  • Prevention of cytokine release syndrome induced by anti CD20/CD3 antibodies
  • Gazyvaro
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023
MHRA-100687-PIP01-22-M01 (update)
  • OBINUTUZUMAB
  • Treatment of systemic lupus erythematosus
  • Gazyvaro
  • Gazyvaro
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 24/08/2023
MHRA-100681-PIP01-22
  • Lomitapide
  • Treatment of (heterozygous or homozygous) familial hypercholesterolaemia
  • Lojuxta hard capsule
  • Other: Hypercholesterolaemia (HoFH)
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100466-PIP01-22
  • zilovertamab vedotin
  • Treatment of malignant neoplasms of haematopoietic and lymphoid tissue
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic, and lymphoid tissue)
  • not available at present
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 30/06/2023
MHRA-100845-PIP01-23-M01 (update)
  • CABOTEGRAVIR
  • Prevention of human immunodeficiency virus (HIV-1) infection
  • VOCABRIA and CABENUVA
  • Apretude
  • APRETUDE
  • Apretude
  • VOCABRIA/APRETUDE
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 20/06/2023
MHRA-100901-PIP01-23-M01 (update)
  • CABOTEGRAVIR
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Vocabria
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100126-PIP01-21-M01 (update)
  • Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene
  • Duchenne Muscular Dystrophy
  • fordadistrogene movaparvovec
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 15/06/2023
MHRA-100598-PIP01-22
  • Cobolimab
  • Treatment of lung cancer
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 25/05/2023