Zusammenfassung der Merkmale des Arzneimittels - Dimethylfumarat Vivanta 240 mg magensaftresistente Hartkapseln
Public Summary of the Risk Management Plan according to Section 34 Sentence 1a sub-section 3 of the
Medicinal Products Act(2)
Administrative Information:
| Wirkstoff | Dimethylfumarat |
| ATC-Code | L04AX07 |
| Darreichungsform | magensaftresistente Hartkapsel |
| Art der Anwendung | zum Einnehmen |
| Inhaber der Zulassung | Vivanta Generics s.r.o. Trtinová 260/1 196 00 CAKOVICE, PRAHA 9 Tschechische Republik |
| Zulassungsnummern | 7011472.00.00 7011473.00.00 |
| Datum der Zulassung | 10.05.2024 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 1.1 / 17.08.2023 |
| Datum der Genehmigung des RMPs | 10.05.2024 |
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 28. Juni 2024 veröffentlicht.
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Part VI: Summary of the risk management plan
This is a summary of the risk management plan (RMP) for Dimethyl fumarate 120 mg & 240 mg, gastro-resistant hard capsules. The RMP details important risks of Dimethyl fumarate, how these risks can be minimised, and how more information will be obtained about Dimethyl fumarate's risks and uncertainties (missing information).
Dimethyl fumarate 120 mg & 240 mg, gastro-resistant hard capsules' Summary of Product Characteristics (SmPC) and its Package Leaflet (PL) give essential information to healthcare professionals and patients on how the capsules should be used.
Important new safety concerns or changes to the current ones will be included in updates of Dimethyl fumarate 120 mg & 240 mg, gastro-resistant hard capsules’ RMP.
Dimethyl fumarate is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). It contains dimethyl fumarate as the active substance, and it is given orally.
Important risks of Dimethyl fumarate, together with measures to minimise such risks and the proposed studies for learning more about Dimethyl fumarate 120 mg & 240 mg, gastro-resistant hard capsules' risks, are outlined below.
Measures to minimise the risks identified for medicinal products can be:
Specific information, such as warnings, precautions, and advice on correct use. in the package leaflet and SmPC addressed to patients and healthcare professionals; Important advice on the medicine’s packaging; The authorised pack size — the amount of medicine in a pack is chosen so to ensure that the medicine is used correctly; The medicine’s legal status — the way a medicine is supplied to the patient (e.g. with or without prescription) can help to minimise its risks.Together, these measures constitute routine risk minimisation measures.
In the case of Dimethyl fumarate 120 mg & 240 mg. gastro-resistant hard capsules, these measures are supplemented with additional risk minimisation measures mentioned under ‘TLB Summary of important risks”, below.
If important information that may affect the safe use of the capsules is not yet available, it is listed under ‘missing information’ below.
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In addition to these measures, infomiation about adverse reactions is collected continuously and regularly analysed so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.
Important risks of Dimethyl fumarate are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely administered.
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 Dimethyl fumarate. 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);
| List of important risks and missing information | |
| Important identified risks | Progressive Multifocal Leukoencephalopathy (PML) Decreases in leukocyte and lymphocyte counts Drug-induced liver injury |
| Important potential risks | Serious and opportunistic infections (other than PML and herpes zoster) Malignancies Effects on pregnancy outcome Interaction with nephrotoxic medications leading to renal toxicity |
| Missing information | Long-term efficacy and safety Safety profile in patients over the age of 55 years Safety profile in patients with moderate to severe renal impairment Safety profile in patients with hepatic impairment Safety profile in patients with severe active GI disease Increased risk of infection in patients concomitantly taking anti-neoplastic or immunosuppressive therapies |