Displaying 1 - 20 of 1154
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-102116-PIP01-25
  • Delpacibart etedesiran
  • Treatment of myotonic disorders
  • Not available at present
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102374-PIP01-26
  • KETAMINE HYDROCHLORIDE
  • SUFENTANIL CITRATE
  • Treatment of acute pain
  • Kemsu
  • Pain
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-102538-PIP01-26
  • ECUR combination of two nonreplicating recombinant adeno-associated virus vectors, libenucgene parvec (ECUR-506A) and rezotcagene parvec (ECUR-506D)
  • Treatment of ornithine transcarbamylase deficiency
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102441-PIP01-26
  • Surovatamig (formerly AZD0486)
  • Treatment of mature B-cell neoplasms
  • Not available at present
  • Oncology
  • Other: Blood and lymphatic system disorders
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102440-PIP01-26
  • Surovatamig (formerly AZD0486)
  • B-Lymphoblastic Leukaemia/lymphoma
  • Not available at present
  • Oncology
  • Other: Blood and lymphatic system disorders
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101616-PIP01-24
  • Multivalent pneumococcal polysaccharide vaccine
  • Prevention of pneumococcal disease caused by S. pneumoniae
  • N/A
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102466-PIP01-26
  • Aleniglipron
  • Treatment of obesity
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102594-PIP01-26
  • ELECOGLIPRON
  • DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
  • Treatment of heart failure
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101711-PIP01-24-M02 (update)
  • IPTACOPAN HYDROCHLORIDE MONOHYDRATE
  • Treatment of C3 glomerulopathy
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101323-PIP01-23
  • tulisokibart
  • Treatment of ulcerative colitis
  • 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-101323-PIP02-24
  • tulisokibart
  • Treatment of Crohn's disease
  • 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-101097-PIP01-23-M02 (update)
  • Modified Vaccinia Ankara – Bavarian Nordic Live virus
  • Prevention of smallpox, mpox and diseases caused by vaccinia virus
  • Imvanex
  • Imvamune
  • Imvanex
  • Imvanex
  • Jynneos
  • Jynneos
  • Jynneos
  • Jynneos
  • IMVANEX (associated names: JYNNEOS, IMVAMUNE)
  • Infectious diseases
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-102591-PIP01-26
  • Bemdaneprocel
  • Treatment of Parkinson’s disease.
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100432-PIP01-22-M01 (update)
  • Zilurgisertib
  • Treatment of fibrodysplasia ossificans progressiva
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100129-PIP01-21-M04 (update)
  • Cipaglucosidase alfa
  • Treatment of glycogen storage disease Type II (Pompe's disease)
  • Pombiliti
  • Pombiliti
  • Pomiliti
  • Pombilti
  • Pombiliti
  • Pombiliti
  • Pombiliti
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100102-PIP01-21-M03 (update)
  • INDACATEROL ACETATE
  • MOMETASONE FUROATE
  • Treatment of asthma
  • Atectura Breezhaler
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101964-PIP01-25-M01 (update)
  • Orforglipron
  • Treatment of Type 2 Diabetes Mellitus
  • Foundayo
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102598-PIP01-26
  • Orelabrutinib
  • Treatment of marginal zone lymphoma
  • Hibruka
  • Hibruka
  • Hibruka
  • Hibruka
  • Yinuokai
  • Yinuokai
  • Yinuokai
  • Yinuokai
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102587-PIP01-26
  • orelabrutinib
  • Treatment of mantle cell lymphoma
  • Hibruka
  • Hibruka
  • Yinuokai
  • Hibruka
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101005-PIP02-26
  • Bocunebart
  • Preventive treatment of migraine
  • Not available at present
  • Neurology
  • Pain
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No