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Displaying 301 - 320 of 1097
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101268-PIP01-23
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H5N1
  • Prevention of pandemic influenza
  • Incellipan
  • Audenz
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-101264-PIP01-23
  • cemdisiran
  • Treatment of myasthenia gravis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101264-PIP01-23
  • cemdisiran
  • Treatment of myasthenia gravis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101263-PIP01-23
  • pozelimab
  • Treatment of myasthenia gravis
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100363-PIP01-21
  • Repagermanium
  • Treatment of focal segmental glomerulosclerosis (FSGS)
  • Uro-Nephrology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100191-PIP02-22
  • albaconazole
  • Treatment of vulvovaginal candidiasis
  • Not available at present
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101210-PIP01-23
  • Zapomeran
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available at present
  • Kostaive
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101269-PIP01-23
  • Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen
  • Prevention of zoonotic influenza
  • Celldemic
  • Audenz
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101112-PIP01-23
  • Interleukin-23 receptor antagonist peptide (JNJ-77242113)
  • Treatment of psoriasis
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100918-PIP01-23
  • BELIMUMAB
  • Treatment of systemic sclerosis
  • Benlysta
  • Benlysta
  • Benlysta
  • Benlysta
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101069-PIP01-23
  • resminostat mesilate
  • Treatment of cutaneous T-cell lymphoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101394-PIP01-24
  • clascoterone
  • Treatment of acne vulgaris
  • Winlevi 10 mg/g cream
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101172-PIP01-23
  • Disitamab vedotin
  • Treatment of solid tumours including central nervous system malignancies
  • Aidixi
  • Aidixi
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101392-PIP01-24
  • Influenza Virus Type A, H1N1
  • Influenza Virus Type A, H3N2
  • Influenza Virus Type B, Victoria lineage
  • Prevention of influenza infection
  • Fluenz
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101103-PIP01-23
  • FINERENONE
  • Treatment of heart failure
  • Kerendia
  • Kerendia
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101169-PIP01-23
  • vibostolimab
  • PEMBROLIZUMAB
  • Treatment of melanoma
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101235-PIP01-23
  • Humanised monoclonal antibody derivative against fibroblast growth factor receptor 3
  • Treatment of achondroplasia
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101215-PIP01-23
  • Rocatinlimab
  • Treatment of prurigo nodularis
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101171-PIP01-23
  • ABBV-CLS-7262 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 vanishing white matter disease
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101298-PIP01-23
  • Ulviprubart
  • Treatment of inclusion body myositis
  • Not available at present
  • Immunology -Rheumatology-Transplantation
  • Other: Musculoskeletal disorders
W: decision granting a waiver in all age groups for the listed condition(s). No