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Displaying 261 - 280 of 1047
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101204-PIP01-23
  • Ravulizumab (ALXN1210)
  • Prevention of kidney injury in high-risk patients with chronic kidney disease undergoing cardiopulmonary bypass
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Uro-Nephrology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100494-PIP01-22-M02 (update)
  • NIVOLUMAB
  • Treatment of malignant neoplasms of lymphoid tissue
  • Treatment of malignant neoplasms of the central nervous system
  • OPDIVO
  • OPDIVO
  • OPDIVO
  • OPDIVO
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100502-PIP01-22-M02 (update)
  • Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • Recombinant Influenza Hemagglutinin-strain B (Victoria lineage)
  • Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage)
  • Prevention of influenza disease
  • Supemtek
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101127-PIP01-23
  • Zimberelimab
  • Treatment of lung cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101126-PIP01-23
  • Zimberelimab
  • Treatment of gastric and gastroesophageal junction adenocarcinoma. Treatment of oesophageal carcinoma.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101400-PIP01-24
  • nirogacestat hydrobromide
  • Treatment of soft tissue sarcoma
  • Not yet available in the United Kingdom (Ogsiveo in the United States and European Union).
  • Ogsiveo
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100086-PIP01-21-M02 (update)
  • UPADACITINIB
  • treatment of atopic dermatitis
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Rinvoq
  • Immunology -Rheumatology-Transplantation
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100921-PIP01-23-M04 (update)
  • AVATROMBOPAG MALEATE
  • Treatment of Idiopathic Thrombocytopenia Purpura
  • Treatment of Thrombocytopenic Purpura Secondary to Liver Disease
  • Doptelet
  • Doptelet
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101301-PIP01-23
  • Fusion protein consisting of relaxin and Fc domain of IgG1
  • Treatment of pulmonary hypertension due to left heart disease.
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101315-PIP01-23
  • NIVOLUMAB
  • relatlimab
  • Treatment of all conditions in the category of malignant neoplasms (except nervous system neoplasms, haematopoietic and lymphoid tissue neoplasms and melanoma)
  • Opdualag
  • Opdualag
  • Opdualag
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101313-PIP01-23
  • maplirpacept
  • Treatment of multiple myeloma.
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101247-PIP01-23
  • empasiprubart
  • Treatment of multifocal motor neuropathy
  • empasiprubart
  • Neurology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101236-PIP01-23
  • Rilzabrutinib
  • Treatment of autoimmune haemolytic anaemia.
  • Haematology-Hemostaseology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101242-PIP01-23-M01 (update)
  • LUMASIRAN SODIUM
  • Treatment of hyperoxaluria.
  • Oxlumo
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101159-PIP01-23
  • MK 2870- Humanised IgG1 monoclonal antibody against TROP2, conjugated to a topoisomerase I inhibitor belotecan-derivative
  • Treatment of lung cancer
  • Treatment of cervical cancer
  • Treatment of ovarian cancer
  • Treatment of endometrial cancer
  • Treatment of gastric cancer
  • Treatment of breast cancer
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101175-PIP01-23
  • baxdrostat
  • Treatment of hypertension
  • Not available at present
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101151-PIP01-23-M01 (update)
  • OBETICHOLIC ACID
  • Treatment of primary biliary cirrhosis
  • Treatment of biliary atresia
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Ocaliva
  • Gastroenterology-Hepatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100146-PIP01-21
  • tezepelumab
  • Treatment of eosinophilic esophagitis
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101111-PIP01-23
  • Cendakimab (BMS-986355)
  • Treatment of Eosinophilic Esophagitis (EoE)
  • Immunology -Rheumatology-Transplantation
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
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