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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort descending	Date Published
MHRA-100386-PIP01-21	patritumab deruxtecan	Treatment of lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100480-PIP01-22	(S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropane-2-yl)-1H-pyrazole-4-carboxamide	Treatment of mature B-cell malignancies		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100516-PIP01-22	Toripalimab	Malignant neoplasms (except CNS, haematopoietic and lymphoid tissue and melanoma).	Not available at present TUOYI	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	03/11/2022
MHRA-100200-PIP01-21-M01 (update)	REGORAFENIB	Treatment of all malignant neoplasms (except haematopoietic and lymphoid tissue)	Stivarga Stivarga	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	04/11/2022
MHRA-100236-PIP01-21-M01 (update)	Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate	Disease caused by Streptococcus pneumoniae		Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	10/11/2022
MHRA-100236-PIP01-21-M02 (update)	Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate	Prevention of disease caused by Streptococcus pneumoniae	Prevnar 20 Apexxnar	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	10/11/2022
MHRA-100092-PIP01-21-M02 (update)	VENETOCLAX	Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue Treatment of solid malignant tumours	Venclyxto Vencylxto Venclyxto Venclyxto Venclyxto Venclyxto Venclyxto Venclyxto	Haematology-Hemostaseology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	30/11/2022
MHRA-100078-PIP01-21-M02 (update)	AVIBACTAM AZTREONAM	Treatment of infections caused by aerobic gram-negative bacteria		Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100401-PIP01-21	Humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135)	Treatment of multiple myeloma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	07/12/2022
MHRA-100187-PIP01-21-M01 (update)	VONICOG ALFA	Treatment of von Willebrand Disease		Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100211-PIP01-21-M01 (update)	VOLANESORSEN SODIUM	Treatment of familial chylomicronemia syndrome	WAYLIVRA WAYLIVRA	Gastroenterology-Hepatology Cardiovascular Diseases Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100216-PIP01-21-M02 (update)	TRALOKINUMAB	Treatment of atopic dermatitis	Adtralza Adtralza Adtralza	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100288-PIP01-21-M01 (update)	DENOSUMAB	Treatment of osteoporosis	Prolia Prolia Prolia Prolia XGEVA XGEVA XGEVA XGEVA	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100296-PIP01-21-M01 (update)	palovarotene	Treatment of fibrodysplasia ossificans progressiva	SOHONOS	Other: Musculo-skeletal	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100323-PIP01-21-M01 (update)	SAXAGLIPTIN	Treatment of Type 2 Diabetes Mellitus	Onglyza Onglyza Onglyza Onglyza Onglyza	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100302-PIP01-21-M01 (update)	CRIZANLIZUMAB	Treatment of sickle cell disease	Adakveo® 10 mg/ml concentrate for solution for infusion	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100329-PIP01-21-M01 (update)	EDOXABAN TOSYLATE	Treatment of venous thromboembolism Prevention of arterial thromboembolism Prevention of Venous thromboembolism	Lixiana film-coated tablets Lixiana	Cardiovascular Diseases Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100333-PIP01-21-M01 (update)	MIRABEGRON	Treatment of neurogenic detrusor overactivity	BETMIGA BETMIGA MYRBETRIQ / MYRBETRIQ GRANULES	Uro-Nephrology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100361-PIP01-21-M01 (update)	GOLIMUMAB	Treatment of ulcerative colitis	Simponi 50 mg solution for injection in pre-filled pen Simponi 50 mg solution for injection in pre-filled syringe Simponi 100 mg solution for injection in pre-filled pen Simponi 45 mg/0.45 mL solution for injection in pre-filled pen Simponi Simponi Simponi Simponi Simponi Simponi Simponi Simponi	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022
MHRA-100408-PIP01-21-M01 (update)	Hepatitis B (rDNA) surface antigen adjuvanted	Prevention of hepatitis B virus infection	HEPLISAV B	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	07/12/2022

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