MHRA paediatric investigation plan
Apexxnar (Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate)
MHRA paediatric investigation plan MHRA-100236-PIP01-21-M03 (update) · Modification
Key facts
| PIP number | MHRA-100236-PIP01-21-M03 (update) |
|---|---|
| Product names | Apexxnar, Prevnar 20 |
| Active substances | 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 and 8 more |
| Therapeutic areas | Vaccines |
| Conditions | Prevention of disease caused by Streptococcus pneumoniae |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Compliance check outcome | Partial |
| Published | Dec 19, 2023 |
| MHRA record | cms.mhra.gov.uk |
About MHRA paediatric investigation plans
A paediatric investigation plan sets out the studies a company must run in children to support authorisation of a medicine in the UK, or records a waiver or deferral.
Source: UK Medicines and Healthcare products Regulatory Agency (MHRA). Contains public sector information licensed under the Open Government Licence v3.0 · Source date: