diff --git a/Meeting Highlights from the Committee for Medicinal Products for Human Use %28CHMP%29 12-15 December 2025.-.md b/Meeting Highlights from the Committee for Medicinal Products for Human Use %28CHMP%29 12-15 December 2025.-.md new file mode 100644 index 0000000..fee8759 --- /dev/null +++ b/Meeting Highlights from the Committee for Medicinal Products for Human Use %28CHMP%29 12-15 December 2025.-.md @@ -0,0 +1 @@ +
The committee recommended to increase using unique Spikevax vaccine and Spikevax bivalent Original/Omicron BA.1 as a booster dose in kids aged 6 to 11 years. The committee recommended converting the conditional advertising and marketing authorisation of the COVID-19 vaccine Jcovden to a regular advertising authorisation. An outline of all the COVID-19 vaccines authorised within the EU is obtainable on EMA’s web site. The agenda of the December 2022 CHMP assembly is published on EMA's website. Minutes of the November 2022 CHMP assembly might be revealed in the coming weeks. Key figures from the December 2022 CHMP assembly are represented within the graphic below. This product was designated as an orphan medication during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) on the time of approval to find out whether the information accessible up to now permits sustaining the medicine’s orphan status and granting the medication ten years of market exclusivity.

Classic infantile-onset Pompe disease typically begins with enzyme substitute therapy (ERT) as soon as a diagnosis is made. In ERT, the infant is recurrently treated with an artificial copy of the acid alpha-glucosidase enzyme. One examine showed that babies treated with ERT earlier than 6 months had larger survival charges in addition to the flexibility to breathe and not using a ventilator. The 2017 research also found that ERT treatment led to better heart well being and improved learning of motor expertise. While ERT isn’t a cure for Pompe disease - no cure presently exists - it may improve high quality of life and improve life expectancy. Along with ERT therapy, treatments that deal with breathing difficulties, trouble swallowing, and physical issues are often additionally crucial. Sometimes a feeding tube is a part of treating infantile Pompe disease, an effort to make sure correct nutrition. Sometimes, delicate or pureed foods are introduced before resorting to a feeding tube.

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