PIP Search Page

Displaying 441 - 460 of 773

PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100236-PIP01-21-M03 (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	Apexxnar Prevnar 20 Apexxnar	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	19/12/2023
MHRA-100470-PIP01-22-M01 (update)	Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis serogroup B fHbp subfamily A Neisseria meningitidis serogroup B fHbp subfamily B Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein	Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y		Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100473-PIP01-22-M01 (update)	Recombinant COVID-19 subunit nanoparticle	Prevention of coronavirus disease 2019 (COVID-19)	SKYCovion	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-101028-PIP01-23-M01 (update)	Cholera vaccine, recombinant, live, oral (strain CVD 103-HgR)	Prevention of cholera	Vaxchora	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100978-PIP01-23	Genetically detoxified Pertussis Toxin (PTgen) and Pertussis Filamentous Haemagglutinin (FHA)	Prevention of Pertussis disease	Pertagen Pertagen Pertagen Pertagen aPgen	Vaccines	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/01/2024
MHRA-100920-PIP01-23	Pneumococcal Polysaccharide Serotype 3 – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 6A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 7F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 19A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 22F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 33F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 8 – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 9N – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 10A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 11A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 12F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 17F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 15A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 15C – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 16F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 23A – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 23B – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 24F – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 31 – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 35B – Diphtheria CRM197 Conjugate Pneumococcal Polysaccharide Serotype 20A – Diphtheria CRM197 Conjugate	Prevention of disease caused by Streptococcus pneumoniae		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100680-PIP01-22	Influenza recombinant H7 haemagglutinin	Prevention of influenza infection		Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100797-PIP01-22	Single-stranded 5' capped mRNA encoding the HAs of the influenza virus strains A and B (mRNA-1010)	Prevention of influenza disease	Not available at present	Vaccines	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/04/2024
MHRA-100197-PIP01-21-M02 (update)	Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)	Prevention of Ebola disease	ERVEBO	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		01/05/2024
MHRA-100601-PIP01-22-M03 (update)	elasomeran imelasomeran DAVESOMERAN ANDUSOMERAN	Prevention of coronavirus disease 2019 (COVID-19)	Spikevax Spikevax bivalent Original/Omicron BA.1 Spikevax bivalent Original/Omicron BA.4-5 Spikevax Spikevax Spikevax bivalent Original/Omicron BA.1 Spikevax Spikevax bivalent Original/Omicron BA.1 Spikevax bivalent Original/Omicron BA.4-5 Spikevax bivalent Original/Omicron BA.1 Spikevax bivalent Original/Omicron BA.1 Spikevax bivalent Original/Omicron BA.4-5 Spikevax bivalent Original/Omicron BA.4-5 Spikevax XBB.1.5 Spikevax XBB.1.5 Spikevax XBB.1.5 Spikevax XBB.1.5 Spikevax XBB.1.5 Spikevax XBB.1.5 Spikevax XBB1.5	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		01/05/2024
MHRA-100673-PIP01-22	Fidrisertib	Treatment of fibrodysplasia ossificans progressiva		Other: Musculoskeletal	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
MHRA-100974-PIP01-23	BOTULINUM TOXIN TYPE A	Treatment of skin wrinkling	Not yet defined	Other: Aesthetics	W: decision granting a waiver in all age groups for the listed condition(s).	No		19/12/2023
MHRA-100156-PIP01-21-M01 (update)	FLUOCINOLONE ACETONIDE	Treatment of non-infectious uveitis Secondary prevention of non-infectious uveitis	ILUVIEN 190 micrograms intravitreal implant in applicator ILUVIEN 190 micrograms intravitreal implant in applicator ILUVIEN 190 micrograms intravitreal implant in applicator ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 mikrogramů intravitreální implantát v aplikátoru ILUVIEN Iluvien 190 mikrogrammaa, implantaatti silmän lasiaiseen, asetin ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 Mikrogramm intravitreales Implantat im Applikator ILUVIEN 190 microgrammi impianto intravitreale in applicatore ILUVIEN 190 microgrammes, implant intravitréen avec applicateur ILUVIEN 190 microgram, intravitreaal implant in applicator Iluvien 190 mikrogram intravitrealt implantat i applikator ILUVIEN, 190 mikrogramów, implant do ciałka szklistego w aplikatorze ILUVIEN 190 microgramas implante intravítreo em aplicador ILUVIEN 190 microgramos implante intravítreo en aplicador Iluvien 190 mikrogram intravitrealt implantat i applikator ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg ILUVIEN fluocinolone acetonide 190 micrograms intravitreal implant in applicator	Ophthamology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		18/03/2022
MHRA-100279-PIP01-21	Humanized monoclonal antibody of IgG1 sub-type targeting the human SEMA3A polypeptide	Diabetic retinopathy		Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No		04/05/2022
MHRA-100370-PIP01-21-M01 (update)	EX VIVO EXPANDED AUTOLOGOUS HUMAN CORNEAL EPITHELIAL CELLS CONTAINING STEM CELLS	Treatment of limbal stem cell deficiency due to ocular burns	Holoclar Holoclar Holoclar	Ophthamology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		27/09/2022
MHRA-100493-PIP01-22	BI 765128 - humanized monoclonal antibody of IgG1 subtype targeting NRP1	Diabetic retinopathy		Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No		25/05/2023
MHRA-100678-PIP01-22	Humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220)	Treatment of uveitic macular oedema	Not available at present	Ophthamology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		19/12/2023
MHRA-101230-PIP01-23	teprotumumab	Treatment of thyroid eye disease	Not available at present TEPEZZA	Ophthamology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-101188-PIP01-23-M01 (update)	fosdenopterin	Treatment of patients with molybdenum cofactor deficiency (MoCD) Type A	Nulibry	Other: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100102-PIP01-21-M01 (update)	MOMETASONE FUROATE INDACATEROL ACETATE	Treatment of asthma	Atectura Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler Atectura Breezhaler Atectura Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021

Download XLSX