Displaying 21 - 40 of 1021
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100198-PIP01-21-M01 (update)
  • RURIOCTOCOG ALFA PEGOL
  • Treatment and prophylaxis of bleeding in patients with haemophilia A
  • Adynovi
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100197-PIP01-21-M03 (update)
  • Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
  • Prevention of Ebola disease
  • ERVEBO
  • ERVEBO
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100170-PIP01-21-M02 (update)
  • CANAGLIFLOZIN HEMIHYDRATE
  • Treatment of Type 2 Diabetes Mellitus
  • Invokana
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100168-PIP01-21-M01 (update)
  • Naloxegol (as naloxegol oxalate)
  • Treatment of opioid-induced constipation
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Moventig
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100166-PIP01-21-M01 (update)
  • ENTRECTINIB
  • Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms).
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Rozlytrek
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100161-PIP01-21-M01 (update)
  • Pneumococcal Polysaccharide Serotype 1 - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 3 - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 4 - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 5 - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 6A - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 6B - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 7F - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 9V - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 14 - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 18C - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 19A - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 19F - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 22F - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 23F - Diphtheria CRM197 Conjugate
  • Pneumococcal Polysaccharide Serotype 33F - Diphtheria CRM197 Conjugate
  • Prevention of disease caused by Streptococcus pneumoniae
  • Not available at present
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100158-PIP01-21-M01 (update)
  • PEMBROLIZUMAB
  • Treatment of Hodgkin lymphoma
  • Keytruda
  • Keytruda
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100148-PIP01-21-M03 (update)
  • LENVATINIB MESILATE
  • Treatment of all conditions included in the category of malignant neoplasms except haematopoietic and lymphoid tissue neoplasms, papillary thryoid cancer, follicular thyroid cancer and osteosarcoma
  • Lenvima
  • Lenvima
  • Kisplyx
  • Kisplyx
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100140-PIP01-21-M01 (update)
  • BENRALIZUMAB
  • Treatment of Hypereosinophilic syndrome (HES)
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA PEN
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • FASENRA
  • Other: Respiratory, thoracic and mediastinal disorders, Immune system disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100111-PIP01-21-M01 (update)
  • Islatravir
  • DORAVIRINE
  • Treatment of human immunodeficiency virus-1 (HIV-1) infection
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100108-PIP01-21-M01 (update)
  • BRIVARACETAM
  • Treatment of epilepsy with partial onset seizures.
  • Briviact
  • Briviact
  • Briviact
  • Briviact
  • Briviact
  • BRIVLERA
  • BRIVLERA
  • Briviact
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100116-PIP01-21-M03 (update)
  • IVACAFTOR
  • TEZACAFTOR
  • ELEXACAFTOR
  • Treatment of Cystic Fibrosis
  • Kaftrio
  • Other: Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100097-PIP01-21-M01 (update)
  • eladocagene exuparvovec
  • Treatment of Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency
  • Upstaza
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100093-PIP01-21-M05 (update)
  • UPADACITINIB
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and juvenile idiopathic arthritis).
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101879-PIP01-25-M01 (update)
  • BECLOMETASONE DIPROPIONATE
  • FORMOTEROL FUMARATE DIHYDRATE
  • GLYCOPYRRONIUM BROMIDE
  • Treatment of asthma
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Trimbow
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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