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PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort descending	Date Published
MHRA-100377-PIP01-21-M01 (update)	ACALABRUTINIB	Treatment of mature B cell neoplasms	calquence calquence	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100352-PIP01-21-M01 (update)	AVAPRITINIB	Treatment of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)	AYVAKYT AYVAKYT AYVAKYT AYVAKYT	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
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	27/09/2022
MHRA-100164-PIP01-21-M01 (update)	Nirmatrelvir RITONAVIR	Treatment of coronavirus disease 2019 (COVID-19) Prevention of coronavirus disease 2019 (COVID-19)	Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid Paxlovid	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100490-PIP01-22-M01 (update)	nirsevimab (MEDI8897)	Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).	Beyfortus	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100177-PIP01-21-M01 (update)	INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN	Prevention of influenza	FLUCELVAX TETRA FLUCELVAX TETRA FLUCELVAX QUADRIVALENT FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX TETRA	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	21/10/2022
MHRA-100198-PIP01-21-M01 (update)	RURIOCTOCOG ALFA PEGOL	Treatment and prophylaxis of bleeding in patients with haemophilia A	Adynovi	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100284-PIP01-21-M01 (update)	MEXILETINE HYDROCHLORIDE	Treatment of myotonic disorders		Other: Muscle disorders	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100283-PIP01-21-M01 (update)	USTEKINUMAB	Treatment of Crohn's disease	Stelara Stelara Stelara Stelara Stelara Stelara Stelara	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100286-PIP01-21-M01 (update)	USTEKINUMAB	Treatment of ulcerative colitis	Stelara Stelara Stelara Stelara Stelara Stelara Stelara	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100321-PIP01-21-M01 (update)	GUSELKUMAB	Chronic idiopathic arthritis (including rheumatoid, psoriatic, ankylosing spondylitis and JIA)	TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100300-PIP01-21-M01 (update)	DARUNAVIR COBICISTAT	Treatment of HIV-1 Infection	REZOLSTA REZOLSTA REZOLSTA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100325-PIP01-21-M01 (update)	NALDEMEDINE	Treatment of opioid-induced constipation	Rizmoic Rizmoic SYMPROIC SYMPROIC	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100343-PIP01-21-M01 (update)	MACITENTAN	Treatment of pulmonary arterial hypertension systemic sclerosis idiopathic pulmonary fibrosis	Opsumit Opsumit Opsumit Opsumit Opsumit Opsumit Opsumit Zependo Opsumit Opsumit Opsumit Opsumit Opsumit Zependo Opsumit Opsumit Opsumit Opsumit	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100334-PIP01-21-M01 (update)	INDACATEROL ACETATE GLYCOPYRRONIUM BROMIDE MOMETASONE FUROATE	Treatment of asthma	Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Zimbus Breezhaler Zimbus Breezhaler Zimbus Breezhaler Zimbus Breezhaler Zimbus Breezhaler	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100268-PIP01-21-M01 (update)	INOTUZUMAB OZOGAMICIN	Treatment of B cell acute lymphoblastic leukaemia	Besponsa Besponsa	Haematology-Hemostaseology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100187-PIP01-21-M02 (update)	VONICOG ALFA	Treatment of von Willebrand Disease	veyvondi Vonvendi veyvondi Vonvendi veyvondi Vonvendi veyvondi	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
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

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