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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-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-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-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-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-100553-PIP01-22-M01 (update)
  • REMIMAZOLAM BESYLATE
  • Sedation
  • General Anaesthesia
  • Byfavo 20mg
  • Anerem
  • Byfavo
  • Byfavo
  • Byfavo
  • Anaesthesiology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/06/2023
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-100447-PIP01-22-M02 (update)
  • Tirzepatide
  • Treatment of Type 2 Diabetes Mellitus
  • Mounjaro
  • Mounjaro
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
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-100709-PIP01-22-M01 (update)
  • rozanolixizumab
  • Treatment of myasthenia gravis
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100714-PIP01-22-M01 (update)
  • Gepotidacin
  • Treatment of uncomplicated urogenital gonorrhoea (GC)
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100720-PIP01-22-M01 (update)
  • Gepotidacin
  • Treatment of uncomplicated urinary tract infections
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100720-PIP01-22-M02 (update)
  • Gepotidacin
  • Treatment of uncomplicated urinary tract infection
  • Not available at present
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 24/08/2023
MHRA-100475-PIP01-22-M01 (update)
  • Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup W polysaccharide conjugated to tetanus toxoid
  • Prevention of invasive meningococcal disease
  • MenQuadfi
  • MenQuadfi
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100959-PIP01-23-M01 (update)
  • DOSTARLIMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies).
  • Jemperli
  • Jemperli
  • Jemperli
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 30/06/2023
MHRA-100733-PIP01-22
  • Botulinum toxin type E
  • Treatment of skin wrinkling
  • Dermatology
 W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100699-PIP01-22-M01 (update)
  • DIROXIMEL FUMARATE
  • Treatment of Multiple Sclerosis
  • Vumerity
  • Vumerity
  • Vumerity
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100029-PIP01-21-M01 (update)
  • RECOMBINANT REPLICATION-INCOMPETENT ADENOVIRUS SEROTYPE 26 VECTOR ENCODING THE SARS-COV-2 SPIKE PROTEIN PER.C6 CELL LINE
  • COVID-19 vaccine (Ad26.COV2-S [recombinant])
  • Prevention of coronavirus disease-2019 (COVID-19)
  • COVID-19 vaccine Janssen
  • Jcovden (previously COVID-19 Vaccine Janssen)
  • Infectious diseases
  • Vaccines
 W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100846-PIP01-23-M01 (update)
  • ENALAPRIL MALEATE
  • Treatment of heart failure
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 30/06/2023
MHRA-100740-PIP01-22
  • Xevinapant
  • Treatment of head and neck epithelial malignant neoplasms
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100775-PIP01-22-M01 (update)
  • (4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-4- hydroxy-1,1-dioxido-1-benzothiepin-5-yl] phenoxy] methyl] phenyl] methyl]-4-aza-1-azoniabicyclo[2.2.2]octane Chloride
  • Maralixibat chloride
  • Treatment of Alagille Syndrome (ALGS)
  • maralixibat chloride
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 01/08/2023
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