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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101897-PIP01-25
  • doxecitine
  • doxribtimine
  • Treatment of thymidine kinase 2 deficiency
  • KYGEVVI
  • Endocrinology-Gynaecology-Fertility-metabolism
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-102032-PIP01-25-M01 (update)
  • Neisseria meningitidis group B fHBP protein subfamily A
  • Neisseria meningitidis group B fHBP protein subfamily B
  • Prevention of invasive meningococcal disease caused by Neisseira meningitidis serogroup B
  • Trumenba
  • Trumenba
  • Trumenba
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102165-PIP01-25
  • adeno-associated viral vector serotype Anc80 containing the 5' portion of human OTOF gene
  • adeno-associated viral vector serotype Anc80 containing the 3' portion of human OTOF gene
  • Treatment of otoferlin gene-mediated hearing loss
  • Oto-Rhino-Laryngology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-102050-PIP01-25
  • Aficamten
  • Treatment of hypertrophic cardiomyopathy
  • Cardiovascular Diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100090-PIP01-21-M01 (update)
  • DUPILUMAB
  • Treatment of atopic dermatitis
  • Dupixent
  • Dupixent
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100078-PIP01-21-M03 (update)
  • AZTREONAM
  • AVIBACTAM
  • Treatment of infections caused by aerobic gram-negative bacteria
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100076-PIP01-21-M01 (update)
  • TENOFOVIR DISOPROXIL FUMARATE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • Treatment of chronic viral hepatitis B
  • Viread
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100062-PIP01-21
  • (14S)-8-[3-(2-{dispiro[2.0.2^(4).1^(3)]heptan-7-yl}ethoxy)-1H-pyrazol-1-yl]-12,12-dimethyl-2lambda^(6)-thia-3,9,11,18,23-penta-azatetracyclo[17.3.1.1^(11,14).0^(5,10)]tetracosa-1(22),5,7,9,19(23),20-hexaene-2,2,4-trione calcium salt hydrate
  • TEZACAFTOR
  • DEUTIVACAFTOR
  • Treatment of Cystic Fibrosis
  • Pneumology - Allergology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100237-PIP01-21-M02 (update)
  • Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage)
  • Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)
  • Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain
  • Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain
  • Prevention of influenza infection
  • Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (QIV-HD)
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101058-PIP01-23
  • SIROLIMUS
  • Treatment of Tuberous Sclerosis
  • Pascomer
  • Dermatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-100920-PIP01-23-M01 (update)
  • Pneumococcal Polysaccharide Serotype 3 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 6A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 7F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 19A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 22F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 33F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 8 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 9N – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 10A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 11A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 12F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 17F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 20A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 15A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 15C – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 16F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23A – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23B – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 24F – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 31 – Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 35B – Diphtheria CRM197 Conjugate
  • Prevention of disease caused by Streptococcus pneumoniae.
  • TBD
  • CAPVAXIVE®
  • CAPVAXIVE™
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100716-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of chronic Graft versus Host Disease
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100552-PIP01-22-M01 (update)
  • RILPIVIRINE HYDROCHLORIDE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • edurant
  • edurant
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
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 Full Compliance Check Granted
MHRA-100496-PIP01-22-M01 (update)
  • RUXOLITINIB PHOSPHATE
  • Treatment of acute Graft versus Host Disease (aGvHD)
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Jakavi
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100303-PIP01-21-M03 (update)
  • EMTRICITABINE
  • TENOFOVIR ALAFENAMIDE FUMARATE
  • COBICISTAT
  • DARUNAVIR ETHANOLATE
  • Treatment of human immunodeficiency virus type-1 (HIV-1) infection
  • Symtuza
  • Symtuza
  • Symtuza
  • Symtuza
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100236-PIP01-21-M03 (update)
  • Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Prevention of disease caused by Streptococcus pneumoniae
  • Apexxnar
  • Prevnar 20
  • Apexxnar
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100200-PIP01-21-M03 (update)
  • REGORAFENIB
  • Treatment of all conditions contained in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Stivarga
  • Stivarga
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100195-PIP01-21-M04 (update)
  • BALOXAVIR MARBOXIL
  • Treatment of Influenza
  • Prevention of Influenza
  • Xofluxa
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Xofluza
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100175-PIP01-21-M01 (update)
  • AGOMELATINE
  • Treatment of major depressive episodes
  • Valdoxan
  • Valdoxan
  • Psychiatry
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
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