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Santhera Pharmaceuticals Holding AG: Santhera Announces Corporate Update and Proposal to Strengthen Capital Structure NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES OR ANY OTHER JURISDICTION IN WHICH IT WOULD BE UNLAWFUL TO DO SO. Pivotal 6-month data readout for vamorolone in Duchenne muscular dystrophy (DMD) expected in the second quarter of 2021 Organization streamlined with a focus on cost savings and progressing vamorolone Preliminary unaudited result for 2020: net sales CHF 15.0 million; net loss CHF 71.2 million; cash on hand as of December 31, 2020, CHF 12.4 millio...

Apply for a traditional herbal registration (THR) How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK. From: Contents THR) before you can market a traditional herbal medicinal product in the UK. A THR is only granted if the medicine is used for minor health conditions where medical supervision is not required (e.g. a cold). If your traditional herbal medicinal product claims to treat major health conditions, you need to apply for a marketing authorisation before you can place it on the market. How to apply Required documents You must incl...

Apply for a licence to market a medicine in the UK How to license a medicine for sale in the UK, including applications through national and international routes. From: Contents Print this page This guidance also covers licensing a medicine in Northern Ireland through the centralised, decentralised and mutual recognition European procedures. Which procedure to follow There are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. The options available will be determined by the intended market a...