![]() Updated SmPC and PIL - Frozen storage instructions The website decision page for the mRNA COVID-19 vaccines has been updated to reflect the fact that the 15-minute observation period following vaccination has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction. ![]() The patient information leaflet has not been changed. someone having a different vaccine to their primary course as a booster) and shorten the interval between the primary course and booster dose from at least 6 months to at least 3 months. This is a change to the Summary of Product Characteristics to allow for third dose heterologous boosting (i.e. Update to PIL - to allow for heterologous boosting and to shorten the dose interval between the primary course and booster dose from at least 6 months to at least 3 months. The batch site address and the Marketing Authorisation Holder (MAH) address in the product information has also been updated. ![]() We have updated the product information for the Moderna COVID-19 vaccine (also known as ‘Spikevax’) to include a warning regarding the risk of flare-ups of capillary leak syndrome (CLS) in individuals who already have CLS. Storage instructions changed from “-25✬ to -15✬” to “-50✬ to -15✬. Shelf-life instructions updated in SPC (sections 6.3 & 6.4) and PIL. Minor change to SmPC text on myo/pericarditis Update the SmPC and PIL to include heavy menstrual bleeding as an adverse event Update the SmPC and PIL to include extensive swelling of the vaccinated limb as an adverse event Update the SmPC and PIL to include urticaria as an adverse event Update the SmPC and PIL to extend the indication for booster dose to the 12+ years age group (previously 18+ years) Updated SmPC & PIL to reflect - Extension of indication to 6-11 y+ immunogenicity. Product information has been updated to reflect the authorisation of the Moderna vaccine (Spikevax) for use in those aged 6 months to 5 years. Shelf-life of the product for Spikevax bivalent BA.4-5 Original/Omicron information updated. The MHRA can confirm that Spikevax does not contain any components of animal origin.Ī full list of ingredients for the qualitative and quantitative composition of the vaccine can be found at point 2 in the Summary of Product Characteristics for COVID-19 Vaccine Moderna.Ī full list of ingredients for the excipient composition of the vaccine can be found at point 6.1 in the Summary of Product Characteristics for COVID-19 Vaccine Moderna.Ī full list of ingredients for the qualitative and quantitative composition of the vaccine and a full list of the excipient composition of the vaccine can be found at point 6 in the Patient Information Leaflet for COVID-19 Vaccine Moderna. See further information in our press release. ![]() This MA has similar requirements to that granted by the MHRA. Spikevax is authorised in Northern Ireland under the MA granted by the EMA on 6 January 2021. The MHRA reviews this application, together with due consideration of the EC decision, before making an independent decision on the quality, safety, and effectiveness of the vaccine. This is when the marketing authorisation application made by the company references the decision made by the European Medicines Agency’s Committee for Medicinal Products for Human Use ( CHMP). The Marketing Authorisation (MA) granted by the MHRA is valid in Great Britain only and was approved via the European Commission ( EC) Decision Reliance Route. It is not intended to provide practical advice on how to use this product. It explains how this product was assessed and how its authorisation was recommended, as well as its conditions of use. The Public Assessment Report ( PAR) is a scientific report, written by the MHRA. This is based on the Summary of Product Characteristics of the product. The Patient Information Leaflet provides information for patients on using the medicine safely. It is used by healthcare professionals, such as doctors, nurses and pharmacists. It explains how to use and prescribe a medicine. ![]() The Summary of Product Characteristics is a description of a medicinal product’s properties and the conditions attached to its use. Information about the Spikevax vaccine (formerly COVID-19 Vaccine Moderna), approved by the MHRA on 8 January 2021. The product information for the Spikevax bivalent Original/Omicron booster vaccine can be found on a separate page. ![]()
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