Displaying 161 - 180 of 268
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-100099-PIP01-21-M02 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
  • Briviact (in Italy: Nubriveo)
  • Briviact
  • Briviact
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100099-PIP01-21-M01 (update)
  • BRIVARACETAM
  • Treatment of paediatric epilepsy syndromes
  • Treatment of neonatal seizures
  • Briviact
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100087-PIP01-21-M01 (update)
  • LACOSAMIDE
  • Treatment of generalised epilepsy and epileptic syndromes
  • VIMPAT
  • lacosamide
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • VIMPAT
  • lacosamide
  • lacosamide
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100049-PIP01-21-M02 (update)
  • IBRUTINIB
  • Treatment of mature B-cell neoplasm
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Imbruvica
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted 17/05/2022
MHRA-100038-PIP01-21-M01 (update)
  • SARS CoV2 prefusion Spike delta TM (CoV2 preS dTM) protein, recombinant adjuvanted with AS03
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vidprevtyn
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100024-PIP01-21-M02 (update)
  • LAROTRECTINIB
  • Malignant neoplasms (except CNS tumours, haematopoietic and lymphoid tissue neoplasms
  • VITRAKVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
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 17/05/2022
MHRA-100324-PIP01-21
  • Loncastuximab tesirine
  • Treatment of mature B-cell neoplasms
  • Zynlonta
  • Zynlonta
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100346-PIP01-21
  • molnupiravir
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Lagevrio
  • Lagevrio
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100381-PIP01-21
  • Regdanvimab
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Regkirona
  • Regkirona Inj.
  • Infectious diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100368-PIP01-21
  • aumolertinib
  • Treatment of lung cancer
  • Ameile
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No 17/05/2022
MHRA-100275-PIP01-21
  • SEMAGLUTIDE
  • Treatment of non-alcoholic steatohepatitis (NASH)
  • Ozempic
  • OZEMPIC 0.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
  • Ozempic
  • Ozempic
  • Ozempic
  • Ozempic
  • OZEMPIC 0.25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
  • OZEMPIC 1 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100208-PIP01-21
  • Peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain
  • Treatment of non-alcoholic steatohepatitis
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100230-PIP01-21
  • Thienopyrimidine Derivative
  • Treatment of fibrosing interstitial lung disease
  • Pneumology - Allergology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100254-PIP01-21
  • epcoritamab
  • Treatment of mature B-cell malignancies
  • Not available at present
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100291-PIP01-21
  • imetelstat
  • Treatment of acute myeloid leukaemia
  • Treatment of Myelodysplastic Syndromes (MDS), including JMML
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100179-PIP01-21
  • vemircopan
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100179-PIP01-21
  • vemircopan
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Haematology-Hemostaseology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100196-PIP01-21
  • SARS-CoV-2 virus, beta-propiolactone inactivated
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Not available
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022
MHRA-100232-PIP01-21
  • ALECTINIB
  • Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • Alecensa
  • Alecensa
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No 17/05/2022