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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-101212-PIP01-23-M01 (update)
  • CEFEPIME DIHYDROCHLORIDE MONOHYDRATE
  • enmetazobactam
  • Treatment of infections caused by gram-negative organisms
  • EXBLIFEP
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100586-PIP01-22-M02 (update)
  • DUPILUMAB
  • Treatment of asthma
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dupixent
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100037-PIP01-21-M02 (update)
  • ponesimod
  • Treatment of Multiple Sclerosis
  • Ponvory
  • Neurology
  • Other: Autoimmune disease/dysfunction
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100989-PIP01-23-M01 (update)
  • DERMATOPHAGOIDES FARINAE
  • DERMATOPHAGOIDES PTERONYSSINUS
  • Treatment of asthma
  • Treatment of allergic rhinitis
  • ACARIZAX and associated names
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • AMITEND
  • ACARIZAX
  • AITARO
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACCARIZAX
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100485-PIP01-22-M02 (update)
  • AMG 176 (4S,7aR,9aR,10S,11E,14S,15R)-6'-chloro-10-methoxy-14,15-dimethyl-3',4',7a,8,9,9a,10,13,14,15-decahydro-2'H,7H-spiro[1,19-ethenocyclobuta[i][1,4]oxazepino[3,4f][1,2,7]thiadiazacyclohexadecine-4,1'-naphthalen]-18(17H)-one 16,16-dioxide
  • Treatment of acute myeloid leukaemia
  • Tapotoclax
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100442-PIP01-22-M02 (update)
  • TALIMOGENE LAHERPAREPVEC
  • Treatment of melanoma
  • Imlygic
  • Imlygic
  • Imlygic
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100068-PIP01-21-M02 (update)
  • VEDOLIZUMAB
  • Treatment of Pouchitis
  • Entyvio
  • Entyvio
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101008-PIP01-23-M01 (update)
  • AMBRISENTAN
  • Pulmonary Arterial Hypertension
  • Volibris
  • Volibris
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100300-PIP01-21-M03 (update)
  • DARUNAVIR
  • COBICISTAT
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100301-PIP05-23
  • Nipocalimab
  • Treatment of Idiopathic inflammatory myopathies
  • Immunology -Rheumatology-Transplantation
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101118-PIP01-23
  • 5’-capped mRNA encoding HPV16 oncoprotein E6 5’-capped mRNA encoding HPV16 oncoprotein E7
  • Treatment of head and neck squamous cell carcinoma
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101115-PIP01-23
  • Sodium ({(2S)-1,4-bis[2-(4-chloro-3-fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1/1)
  • Treatment of Amyotrophic lateral sclerosis
  • Not available at present
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100797-PIP01-22
  • Single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B (mRNA-1010)
  • Prevention of influenza disease
  • Not available at present
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100789-PIP01-22
  • Fazirsiran
  • Treatment of congenital alpha-1 antitrypsin deficiency
  • Not available at present
  • Gastroenterology-Hepatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100562-PIP01-22
  • strontium-82 chloride/ rubidium-82 chloride
  • Visualisation of myocardial perfusion for diagnostic purposes
  • Ruby-Fill
  • Ruby-Fill
  • Ruby-Fill
  • Cardiovascular Diseases
  • Diagnostic
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100971-PIP01-23
  • Sipavibart (AZD3152)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Infectious diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100689-PIP01-22
  • Dersimelagon
  • Treatment of systemic sclerosis
  • Other: Autoimmune and immune dysfunction diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100680-PIP01-22
  • Influenza recombinant H7 haemagglutinin
  • Prevention of influenza infection
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100103-PIP01-21
  • Rozanolixizumab
  • Treatment of myelin oligodendrocyte glycoprotein antibody-associated disease
  • Not available at present
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100594-PIP01-22
  • N-[4-(6-fluoro-3,4-dihydro-1H-isoquinolin-2-yl)-2,6-dimethyl-phenyl]-3,3-dimethylbutanamide
  • Treatment of focal onset seizures
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
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