Overview. On 30 January 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Capvaxive, a vaccine intended for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae.. The applicant for this medicinal product is Merck Sharp & Dohme B.V.

4 days ago · Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in ...

5 days ago · EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its January 2025 meeting. The CHMP recommended granting a marketing authorisation for Capvaxive (pneumococcal polysaccharide conjugate vaccine (21-valent)), a vaccine intended for the prevention of invasive disease and pneumonia caused by streptococcus ...

4 days ago · RAHWAY, N.J.-- (BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the...

Capvaxive

4 days ago · The CHMP’s recommendation will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway, and a final decision is expected by the second quarter of 2025. ... Please see Prescribing Information for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) ...

1 day ago · RAHWAY - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in ...

4 days ago · The CHMP's recommendation is for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.

4 days ago · Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...

4 days ago · Merck announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, recommended the approval of capvaxive for active immunization for the ...