Displaying 141 - 160 of 933
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
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 24/06/2024
MHRA-101277-PIP01-23
  • LIVE ATTENUATED MEASLES VIRUS (SCHWARZ STRAIN)
  • LIVE ATTEN'D MUMPS VIRUS (RIT 4385 DERIVED FROM JERYL LYNN)
  • LIVE ATTENUATED RUBELLA (WISTAR RA 27/3 STRAIN)
  • Varicella virus Oka strain (live, attenuated)
  • Prevention of measles, mumps, rubella and varicella
  • Vaccines
W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-101156-PIP01-23
  • Cagrilintide
  • SEMAGLUTIDE
  • Type 2 Diabetes mellitus
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-101265-PIP01-23
  • efgartigimod alfa
  • Treatment of thyroid eye disease
  • Vyvgar
  • Vyvgart
  • Vyvgart
  • Endocrinology-Gynaecology-Fertility-metabolism
W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-101226-PIP01-23
  • Volrustomig
  • Treatment of cervical cancer
  • Treatment of renal cell carcinoma
  • Treatment of lung cancer
  • Treatment of mesothelioma
  • Volrustomig
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024
MHRA-101222-PIP01-23
  • SJP-0132
  • Treatment of Dry Eye Disease
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No 24/06/2024