Zusammenfassung der Merkmale des Arzneimittels - Ezetimib/Simvastatin Ascend 10 mg/20 mg Tabletten
Public Summary of the Risk Management Plan according to Section 34 Sentence 1a sub-section 3 of the
Medicinal Products Act(2)
Ezetimib/Simvastatin Ascend 10 mg/10 mg Tabletten
Ezetimib/Simvastatin Ascend 10 mg/20 mg Tabletten
Ezetimib/Simvastatin Ascend 10 mg/40 mg Tabletten
Ezetimib/Simvastatin Ascend 10 mg/80 mg Tabletten
Administrative Information:
| Wirkstoffe | Ezetimib Simvastatin |
| ATC-Code | C10BA02 |
| Darreichungsform | Tablette |
| Art der Anwendung | zum Einnehmen |
| Inhaber der Zulassung | Ascend GmbH c/o Pollux Business Center GmbH Sebastian-Kneipp-Straße 41 60439 Frankfurt am Main Deutschland |
| Zulassungsnummern | 2203533.00.00 2203534.00.00 2203535.00.00 2203536.00.00 |
| Datum der Zulassung | 07.10.2022 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 0.1 / 04.01.2019 |
| Datum der Genehmigung des RMPs | 07.10.2022 |
Der im Folgenden wiedergegebene Ausschnitt des Risikomanagement-Plans (RMP) der o. g. Arzneimittel ist eine Zusammenfassung der wesentlichen Inhalte des RMP. Der RMP beschreibt die zu ergreifenden Maßnahmen zur Arzneimittelsicherheit, die Aktivitäten im Risikomanagement und in der Risikoanalyse um sicherzustellen, dass diese Arzneimittel so sicher wie möglich angewendet werden.
Weitere Informationen zu RMP-Zusammenfassungen finden Sie(nur auf Englisch verfügbar).
Diese RMP-Zusammenfassung sollte in Verbindung mit der Zusammenfassung des öffentlichen Bewertungsberichts und der Produktinformation zu o. g. Arzneimitteln gelesen werden, welche Sie auf der Produktseite auf PharmNet.Bundfinden können.
Diese Zusammenfassung des RMPs wurde durch das Bundesinstitut für Arzneimittel und Medizinprodukte am 16. November 2022 veröffentlicht.
(1)
(2)
This is a summary of the risk management plan (RMP) for Ezetimibe/Simvastatin 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg Tablets. The RMP details important risks of Ezetimibe/Simvastatin 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg Tablets, how these risks can be minimised, and how more information will be obtained about Ezetimibe/Simvastatin 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg Tablet’s risks and uncertainties (missing information).
Ezetimibe/Simvastatin 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg Tablet’s summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Ezetimibe/Simvastatin 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg Tablets should be used.
Ezetimibe/Simvastatin 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg Tablets is authorised for Prevention of Cardiovascular Events, Hypercholesterolaemia and as adjunctive therapy Homozygous Familial Hypercholesterolaemia (HoFH) (see SmPC for the full indication). It contains ezetimibe/simvastatin as the active substance and it is given by oral route.
Important risks of Ezetimibe/Simvastatin 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg Tablets, together with measures to minimize such risks, are outlined below.
Measures to minimise the risks identified for Ezetimibe/Simvastatin 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg Tablets:
Specific information, including warnings, precautions, and advice on correct use, in the package leaflet and SmPC addressed to patients and healthcare professionals; Prescription only medicine.Together, these measures will constitute routine risk minimisation measures.
In addition to these measures, information about adverse reactions is collected continuously and regularly analysed, so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.
The important information that may affect the safe use of Ezetimibe/Simvastatin 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg Tablets is not yet available, it is listed under ‘missing information’ below
II.A List of important risks and missing information:
Important risks of Ezetimibe/Simvastatin 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg Tablets are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely taken. Important risks can be regarded as identified or potential. Identified risks are concerns for which there is sufficient proof of a link with the use of Ezetimibe/Simvastatin 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg Tablets. Potential risks are concerns for which an association with the use of this medicine is possible based on available data, but this association has not been established yet and needs further evaluation. Missing information refers to information on the safety of the medicinal product that is currently missing and needs to be collected (e.g. on the long-term use of the medicine);
| Important identified risks | Myopathy/ Rhabdomyolysis Abnormal liver functions Hypersensitivity reactions Drug interaction with warfarin, another coumarin anticoagulant, or fluindione Drug interaction with cyclosporine |
| Important potential risks | Pancreatitis Cholecystitis/Cholelithiasis Interstitial Lung disease Simvastatin Hypersensitivity Syndrome New onset diabetes/Impaired glucose metabolism Haemorrhagic stroke |
| Missing information | Exposure during pregnancy and lactation Use in children (limited clinical trial experience in children 10–17years of age, no clinical trial experience in children younger than 10 years of age) |
II.B Summary of important risks
The safety information in the proposed Product Information is aligned to the reference medicinal product.