{"id":44979,"date":"2026-09-11T10:26:47","date_gmt":"2026-09-11T08:26:47","guid":{"rendered":"https:\/\/celonpharma.com\/?p=44979"},"modified":"2026-09-11T10:26:48","modified_gmt":"2026-09-11T08:26:48","slug":"current-report-no-20-2026-positive-notified-body-opinion-for-the-pen-injector-used-in-the-development-of-celon-pharmas-semaglutide-product","status":"publish","type":"post","link":"https:\/\/celonpharma.com\/en\/current-report-no-20-2026-positive-notified-body-opinion-for-the-pen-injector-used-in-the-development-of-celon-pharmas-semaglutide-product\/","title":{"rendered":"Current Report No. 20\/2026 &#8211; Positive Notified Body Opinion for the Pen Injector Used in the Development of Celon Pharma\u2019s Semaglutide Product"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Legal basis:<\/strong> Article 17(1) of the Market Abuse Regulation (MAR) \u2013 Inside Information<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">With reference to Current Report No. 17\/2026 dated 20 August 2026 concerning the positive results of the bioequivalence study of a medicinal product containing semaglutide, the Management Board of Celon Pharma S.A. (the \u201cCompany\u201d) hereby announces that it has received a positive Notified Body Opinion from T\u00dcV Rheinland LGA Products GmbH (NB 0197) concerning the compliance of the pre-filled pen injector, which constitutes an integral part of the medicinal product (the \u201cPen Injector\u201d), with the applicable General Safety and Performance Requirements (\u201cGSPR\u201d) set out in Annex I to Regulation (EU) 2017\/745 of the European Parliament and of the Council on medical devices (the \u201cMDR\u201d).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Opinion was issued in accordance with Article 117 of the MDR and confirms that the pre-filled Pen Injector complies with the applicable safety and performance requirements, including those relating to design and manufacture and the information supplied with the device.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The assessment also covered the Pen Injector manufacturing process, including the process controls applied, validation activities and the manufacturing environment, as well as Human Factors Studies, all of which were considered to be appropriately controlled and monitored.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Obtaining the above-mentioned positive Opinion represents a significant milestone in the regulatory approval process for Celon Semaglutide. The Opinion is required as part of the product\u2019s marketing authorisation dossier and enables the Company to continue the development of the project in accordance with the planned timeline.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Legal basis: Article 17(1) of the Market Abuse Regulation (MAR) \u2013 Inside Information With reference to Current Report No. 17\/2026 dated 20 August 2026 concerning the positive results of the bioequivalence study of a medicinal product containing semaglutide, the Management Board of Celon Pharma S.A. (the \u201cCompany\u201d) hereby announces that it has received a positive<a class=\"excerpt-read-more float-right\" href=\"https:\/\/celonpharma.com\/en\/current-report-no-20-2026-positive-notified-body-opinion-for-the-pen-injector-used-in-the-development-of-celon-pharmas-semaglutide-product\/\" title=\"ReadCurrent Report No. 20\/2026 &#8211; Positive Notified Body Opinion for the Pen Injector Used in the Development of Celon Pharma\u2019s Semaglutide Product\">Read more &raquo;<\/a><\/p>\n","protected":false},"author":20,"featured_media":31750,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[46],"tags":[],"class_list":["post-44979","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-current-reports"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Current Report No. 20\/2026 - Positive Notified Body Opinion for the Pen Injector Used in the Development of Celon Pharma\u2019s Semaglutide Product - Celon Pharma<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/celonpharma.com\/en\/current-report-no-20-2026-positive-notified-body-opinion-for-the-pen-injector-used-in-the-development-of-celon-pharmas-semaglutide-product\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Current Report No. 20\/2026 - Positive Notified Body Opinion for the Pen Injector Used in the Development of Celon Pharma\u2019s Semaglutide Product - Celon Pharma\" \/>\n<meta property=\"og:description\" content=\"Legal basis: Article 17(1) of the Market Abuse Regulation (MAR) \u2013 Inside Information With reference to Current Report No. 17\/2026 dated 20 August 2026 concerning the positive results of the bioequivalence study of a medicinal product containing semaglutide, the Management Board of Celon Pharma S.A. 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