Displaying 1 - 20 of 1188
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101550-PIP01-24
  • Troriluzole Hydrochloride
  • Treatment of hereditary spinocerebellar ataxia
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101674-PIP01-24
  • Linvoseltamab
  • Treatment of multiple myeloma
  • LYNOZYFIC
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101676-PIP01-24
  • HUMAN ANTI-D IMMUNOGLOBULIN
  • Prevention of Rhesus (Rh) isoimmunisation
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Haematology-Hemostaseology
  • Other: Immunology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101704-PIP01-24
  • Nucresiran sodium
  • Treatment of transthyretin amyloidosis
  • Neurology
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101718-PIP01-24
  • Human alpha-1-proteinase inhibitor immunoglobulin G fusion protein, recombinant
  • Treatment of emphysema secondary to congenital deficiency of alpha-1 antitrypsin
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101579-PIP01-24
  • AZD0780
  • Treatment of elevated cholesterol
  • Treatment of mixed dyslipidaemia
  • AZD0780
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100326-PIP02-24
  • Gemcitabine (hydrochloride)
  • Treatment of malignant bladder neoplasms
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101278-PIP01-23
  • oveporexton
  • Treatment of narcolepsy.
  • Treatment of idiopathic hypersomnia.
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101750-PIP01-24
  • Tenapanor
  • Treatment of hyperphosphataemia
  • Xphozah
  • Phozevel
  • Uro-Nephrology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101752-PIP01-24
  • BELZUTIFAN
  • Treatment of neuroendocrine tumours
  • Welireg
  • Welireg
  • Welireg
  • Welireg
  • Welireg
  • Welireg
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101789-PIP01-25
  • Vixarelimab
  • Treatment of idiopathic pulmonary fibrosis (IPF)
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101761-PIP01-24
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2)
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage)
  • Prevention of influenza infection
  • Adjuvanted Trivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Vaccines
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101748-PIP01-24
  • Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the strains: A/(H1N1)-Like Virus Antigen A/(H3N2)-Like Virus Antigen B/-Like Virus Antigen
  • Prevention of influenza
  • Cell-based Trivalent Influenza Vaccine Seqirus suspension for injection in pre-filled syringe
  • FLUCELVAX
  • FLUCELVAX
  • FLUCELVAX
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-100149-PIP01-21
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Nuvaxovid (proposed invented name)
  • Infectious diseases
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100149-PIP01-21-M01 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid (Please note that details provided herein specifically relate to Singapore)
  • Nuvaxovid
  • Nuvaxovid (Please note that details provided herein specifically relate to Singapore)
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • TBD - Approval not yet granted
  • TBD - Approval not yet granted
  • Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100149-PIP01-21-M02 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100149-PIP01-21-M03 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Nuvaxovid dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100021-PIP01-21
  • Recombinant SARS-CoV-2 spike (S)-protein virus-like particle
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-100021-PIP01-21 -M01 (update)
  • Recombinant SARS-CoV-2 spike (S)-protein virus-like particle
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100023-PIP01-21-M01 (update)
  • bimekizumab
  • Treatment of psoriasis
  • Bimzelx
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No