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authorised medicines abroad e.g. Sativex ® UK labeling excerpt • active ingredients • two soft extracts from Cannabis sativa leaf and flower corresp. to 61-71% delta-9-tetrahydrocannabinol and 60-71% cannabidiol. • dosage form • Oromucosal spray • indication • symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy • dosage • titration period is required to reach optimal dose 4
Switzerland: Legal Situation I enacted by swiss government / commencement date: July 1 st 2011 Ordinance on the Control of Narcotics of May 25 th 2011 Verordnung über die Betäubungsmittelkontrolle vom 25. Mai 2011 (Betäubungsmittelkontrollverordnung, BetmKV) application for marketing authorisation for a medicinal product containing preparations made of Cannabis sativa L. is possible 5
Page 1 and 2: The Way to the Cannabis Medication
Page 3: authorised medicines abroad e.g. Ma
Page 7 and 8: Switzerland: Legal Situation III Or
Page 9 and 10: Switzerland: Legal Situation V Admi
Page 11 and 12: Documentation I • about analytica
Page 13 and 14: Herbal medicinal products: Document
Page 15 and 16: Authorisation Procedure - Overview
Page 17: Swissmedic / Swiss Agency for Thera

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