Search Filters:

The items contained in the list are being used to filter the search results. Click them to remove them from the search filter.
Displaying 141 - 160 of 599
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100430-PIP01-22
  • ±3,4-methylenedioxymethamphetamine hydrochloride (MDMA)
  • Treatment of post-traumatic stress disorder
  • Not available at present
  • Psychiatry
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100612-PIP01-22
  • Fosmanogepix
  • Treatment of invasive fungal infections
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100118-PIP02-22
  • OCRELIZUMAB
  • Treatment of Multiple Sclerosis
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100788-PIP01-22
  • favezelimab
  • PEMBROLIZUMAB
  • Treatment of Hodgkin lymphoma
  • Not availble at present
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100513-PIP01-22
  • efgartigimod alfa
  • Treatment of dermatomyositis
  • Treatment of immune-mediated necrotizing myopathy
  • Treatment of polymyositis (including antisynthetase syndrome)
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100721-PIP01-22
  • Recombinant fusion protein linking iduronate 2-sulfatase to engineered Fc with binding site for transferrin receptor (DNL310)
  • Treatment of mucopolysaccharidosis II (Hunter syndrome)
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100424-PIP01-22
  • zilebesiran sodium
  • Treatment of hypertension
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100966-PIP01-23
  • COVID-19 Vaccine (recombinant, adjuvanted)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100578-PIP01-22
  • Cagrilintide
  • SEMAGLUTIDE
  • Treatment of obesity
  • Not available at present
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 24/08/2023
MHRA-100641-PIP01-22-M02 (update)
  • DURVALUMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue)
  • IMFINZI
  • IMFINZI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 14/08/2023
MHRA-100740-PIP01-22
  • Xevinapant
  • Treatment of head and neck epithelial malignant neoplasms
  • Not available at present
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
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. No 30/06/2023
MHRA-100164-PIP01-21-M02 (update)
  • Nirmatrelvir
  • RITONAVIR
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Prevention of Coronavirus Disease 2019 (COVID-19)
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Paxlovid
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100717-PIP01-22-M01 (update)
  • RISDIPLAM
  • Treatment of spinal muscular atrophy
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Evrysdi
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100130-PIP01-21-M02 (update)
  • BUPIVACAINE
  • Postsurgical analgesia
  • EXPAREL liposomal
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • EXPAREL
  • Pain
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100029-PIP01-21-M01 (update)
  • RECOMBINANT REPLICATION-INCOMPETENT ADENOVIRUS SEROTYPE 26 VECTOR ENCODING THE SARS-COV-2 SPIKE PROTEIN PER.C6 CELL LINE
  • COVID-19 vaccine (Ad26.COV2-S [recombinant])
  • Prevention of coronavirus disease-2019 (COVID-19)
  • COVID-19 vaccine Janssen
  • Jcovden (previously COVID-19 Vaccine Janssen)
  • Infectious diseases
  • Vaccines
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100351-PIP01-21-M01 (update)
  • DOLUTEGRAVIR
  • RILPIVIRINE
  • Treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection.
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JASUPA
  • Juluca 50mg/25mg film-coated tablets
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • JULUCA
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100699-PIP01-22-M01 (update)
  • DIROXIMEL FUMARATE
  • Treatment of Multiple Sclerosis
  • Vumerity
  • Vumerity
  • Vumerity
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100733-PIP01-22
  • Botulinum toxin type E
  • Treatment of skin wrinkling
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023
MHRA-100684-PIP01-22
  • Clazakizumab
  • Prevention of cardiovascular events in patients with atherosclerosis
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No 30/06/2023