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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101349-PIP01-24
  • SECUKINUMAB
  • Treatment of rotator cuff tendinopathy
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Cosentyx
  • Immunology -Rheumatology-Transplantation
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101000-PIP01-23-M02 (update)
  • Rilzabrutinib
  • Treatment of immune thrombocytopenia.
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100678-PIP01-22-M01 (update)
  • vamikibart
  • Treatment of uveitic macular oedema
  • Ophthamology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101282-PIP01-23
  • eftilagimod alfa
  • Treatment of non-small cell lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101094-PIP01-23-M01 (update)
  • Givinostat
  • Treatment of Duchenne muscular dystrophy
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100312-PIP01-21-M02 (update)
  • RITLECITINIB TOSYLATE
  • Treatment of alopecia areata
  • Litfulo
  • Litfulo
  • Litfulo
  • Litfulo
  • Litfulo
  • Dermatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100580-PIP01-22-M02 (update)
  • CEMIPLIMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue)
  • Libtayo
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101375-PIP01-24-M01 (update)
  • FREMANEZUMAB
  • Prophylaxis of migraine headaches
  • Ajovy
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100690-PIP01-22-M02 (update)
  • IMIPENEM MONOHYDRATE
  • CILASTATIN SODIUM
  • RELEBACTAM MONOHYDRATE
  • Treatment of infections caused by gram-negative organisms.
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • RECARBRIO
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101409-PIP01-24-M01 (update)
  • IVOSIDENIB
  • Treatment of Acute Myeloid Leukaemia.
  • Tibsovo
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100038-PIP01-21-M03 (update)
  • Recombinant SARS-CoV-2 spike protein
  • Prevention of coronavirus disease 2019 (COVID-19)
  • VidPrevtyn Beta
  • VidPrevtyn Beta
  • Vaccines
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100343-PIP01-21-M04 (update)
  • MACITENTAN
  • Treatment of pulmonary arterial hypertension
  • Treatment of systemic sclerosis
  • Treatment of idiopathic pulmonary fibrosis
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100931-PIP01-23-M02 (update)
  • mirikizumab
  • Treatment of ulcerative colitis
  • Treatment of Crohn's disease
  • Omvoh
  • Omvoh
  • Omvoh
  • Omvoh
  • Omvoh
  • Omvoh
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100991-PIP01-23-M01 (update)
  • Maralixibat chloride
  • Progressive familial intrahepatic cholestasis (PFIC)
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • LIVMARLI
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100262-PIP01-21-M02 (update)
  • DALBAVANCIN HYDROCHLORIDE
  • Treatment of acute bacterial skin and skin structure infections (ABSSSI)
  • Xydalba
  • Xydalba
  • Xydalba
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100701-PIP01-22-M02 (update)
  • Recombinant Neisseria meningitis group B Protein 936-741
  • Meningococcal group W-135 oligosaccharides conjugated to Corynebacterium diptheriae CRM197 protein
  • Meningococcal group A oligosaccharides conjugated to Corynebacterium diptheriae CRM197 protein
  • Recombinant Neisseria meningitis group B Protein 287-953
  • Recombinant Neisseria meningitis group B Protein 961c
  • Meningococcal group Y oligosaccharides conjugated to Corynebacterium diptheriae CRM197 protein
  • Outer Membrane Vesicles (OMV) from N. meningitidis Strain NZ 98/254
  • Meningococcal group C oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Prevention of meningococcal meningitis
  • Not available at present
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100868-PIP01-23-M02 (update)
  • AFAMELANOTIDE
  • Treatment of erythropoietic protoporphyria (EPP)
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • SCENESSE
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100070-PIP01-21-M01 (update)
  • molnupiravir
  • Treatment of coronavirus disease 2019 (COVID-19)
  • Lagevrio
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101362-PIP01-24-M01 (update)
  • ZANAMIVIR
  • Prevention of influenza
  • Treatment of influenza
  • Relenza (inhalation powder)
  • Dectova (solution for infusion)
  • Dectova
  • Dectova
  • Relenza
  • Relenza
  • Relenza
  • Relenza
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101360-PIP01-24-M01 (update)
  • Purified Rabies virus, WISTAR PM/WI 38-1503-3M strain (inactivated)
  • Prevention of rabies viral infection
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
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