Displaying 21 - 40 of 1121
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-102390-PIP01-26
  • empasiprubart
  • Treatment of Chronic Inflammatory Demyelinating Polyneuropathy
  • Not available at present
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100606-PIP01-22-M03 (update)
  • SPARSENTAN
  • Treatment of focal segmental glomerulosclerosis
  • Other: Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101488-PIP01-24-M02 (update)
  • Etavopivat
  • Treatment of sickle cell disease
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-102207-PIP01-25
  • Dazukibart
  • Treatment of idiopathic inflammatory myopathy
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102442-PIP01-26
  • Gocatamig
  • Neuroendocrine carcinomas (excluding Neuroblastoma)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102427-PIP01-26
  • BRIMONIDINE TARTRATE
  • CARBACHOL
  • Treatment of presbyopia
  • YUVEZZI
  • YUVEZZI
  • Ophthamology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102026-PIP01-25
  • DB-OTO
  • Treatment of otoferlin gene-mediated hearing loss
  • Other: Audiology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102444-PIP01-26
  • MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE
  • Treatment of myelodysplastic syndrome
  • Omjjara
  • Ojjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • OJJAARA
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara
  • Ojjara
  • Omjjaara
  • Omjjara
  • Omjjara
  • Omjjara
  • Omjjara 100mg Film coated tablet PLGB 19494/0318
  • Omjjara 150mg Film coated tablet PLGB 19494/0322
  • Omjjara 200mg Film coated tablet PLGB 19494/0323
  • Other: Congenital, familial and genetic disorders, neoplasms benign, malignant and unspecified (including cysts and polyps)
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102542-PIP01-26-M01 (update)
  • CEFTOBIPROLE MEDOCARIL SODIUM
  • Treatment of pneumonia
  • Zevtera and associated names
  • Zevtera
  • Mabelio
  • Zevtera
  • Zevtera
  • Zevtera
  • Mabelio
  • Mabelio
  • Mabelio
  • Zevtera
  • Zevtera
  • Zevtera
  • Zevtera
  • Adaluzis
  • Zevtera
  • Zevtera
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102252-PIP01-25
  • mavorixafor
  • Treatment of WHIM (Warts, Hypogammaglobulinaemia, Infections, and Myelokathexis) syndrome
  • Xolremdi
  • Xolremdi
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-102342-PIP01-26
  • Sepiapterin
  • Treatment of hyperphenylalaninaemia
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Sephience
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-100709-PIP01-22-M03 (update)
  • Rozanolixizumab
  • Treatment of myasthenia gravis
  • Rystiggo
  • Rystiggo
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101078-PIP01-23-M03 (update)
  • OLAPARIB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic, and lymphoid tissue).
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Lynparza
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102526-PIP01-26
  • Egalognastat hydrocloride
  • Treatment of Progressive Supranuclear Palsy
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102345-PIP01-26
  • precemtabart tocentecan
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, hematopoietic and lymphoid tissue neoplasms).
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102403-PIP01-26
  • mebufotenin benzoate
  • Treatment of Major Depressive Disorder
  • Neurology
  • Psychiatry
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102479-PIP01-26
  • FLUTICASONE FUROATE
  • UMECLIDINIUM BROMIDE
  • VILANTEROL TRIFENATATE
  • Treatment of asthma
  • Trelegy Ellipta
  • Trelegy Ellipta/ Elebrato Ellipta
  • Trelegy Ellipta (PLGB 19494/0287)
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102114-PIP01-25
  • Standardised allergen extract of peanut kernels (Arachis hypogaea)
  • Treatment of peanut allergy
  • Not available at present
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101354-PIP01-24-M01 (update)
  • UPADACITINIB
  • Treatment of alopecia areata
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102377-PIP01-26
  • PIBRENTASVIR
  • GLECAPREVIR
  • Treatment of acute hepatitis C virus (HCV) infection
  • Maviret 100 mg / 40 mg Film-coated tablet
  • Maviret 50 mg / 20 mg Coated granules in sachet
  • Infectious diseases
W: decision granting a waiver in all age groups for the listed condition(s). No