Generated Narrative: RegulatedAuthorization MA-52042011 Profile: IDMP RegulatedAuthorization identifier: http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MarketingAuthorisationNumber/52042011 subject: MedicinalProductDefinition: extension = Tablet and solvent for rectal suspension,Distale Form der Colitis ulcerosa bei ungenügendem Ansprechen auf oder Kontraindikation für Mesalazin.; identifier = http://SMC.ch/ig/idmp/NamingSystem/IDSystem-ch-MPID#CH-7601001346451-5204201; domain = Human; combinedPharmaceuticalDoseForm = Tablet and solvent for rectal suspension; indication = Leichte bis mittelschwere Colitis ulcerosa des Rectums sowie des Colon sigmoideum.; legalStatusOfSupply = Medicinal product subject to medical or veterinary prescription (B); additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Authorised for the treatment in children; classification = budesonide,NA KAS art. 12 para. 5 TPLO,Synthetic,Originator product type: Marketing Authorisation region: Switzerland status: valid statusDate: 1993-06-18 holder: Organization Tillotts Pharma AG regulator: Organization SMC Generated Narrative: Organization #holder-Tillotts-Pharma-AG Profile: CH EPL Organization identifier: LOC Identifier/100005174, GLN Identifier/7601001346451 name: Tillotts Pharma AG Generated Narrative: Organization #regulator-SMC Profile: CH EPL Organization identifier: LOC Identifier/100010911, GLN Identifier/7601001398511 name: SMC