Beipackzettel - Adifemu 240 mg
Zusammenfassung des Risikomanagement-Plans gemäß § 34
Public Summary of the Risk Management Plan according to Section 34 Sentence 1a sub-section 3 of the
Medicinal Products Act(2)
Adifemu 120 mg
Adifemu 240 mg
Administrative Information:
| Wirkstoff | Dimethylfumarat |
| ATC-Code | L04AX07 |
| Darreichungsform | magensaftresistente Hartkapsel |
| Art der Anwendung | zum Einnehmen |
| Inhaber der Zulassung | Vipharm S.A. ul. Artura i Franciszka Radziwillów 9 05–850 OZARÓW MAZOWIECKI Polen |
| Zulassungsnummern | 7010731.00.00 7010732.00.00 |
| Datum der Zulassung | 19.11.2023 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 0.4 / 21.04.2023 |
| Datum der Genehmigung des RMPs | 19.11.2023 |
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 29. Dezember 2023 veröffentlicht.
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(1)
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(2)
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. This RMP details important risks of [Dimethyl fumarate] 120 mg & 240 mg gastro-resistant hard capsules, how these risks can be minimised, and how more information will be obtained about [Dimethyl fumarate] 120 mg & 240 mg gastro-resistant hard capsules risks and uncertainties (missing information).
[Dimethyl fumarate] 120 mg & 240 mg gastro-resistant hard capsules’ summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how [Dimethyl fumarate] 120 mg & 240 mg gastro-resistant hard capsules should be used.
Important new concerns or changes to the current ones will be included in updates of [Dimethyl fumarate] 120 mg & 240 mg gastro-resistant hard capsules’ RMP.
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I. The medicine and what it is used for
[Dimethyl fumarate] 120 mg & 240 mg gastro-resistant hard capsules is authorised 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.
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II. Risks associated with the medicine and activities to minimise or further characterise the risks
Important risks of [Dimethyl fumarate] 120 mg & 240 mg gastro-resistant hard capsules, together with measures to minimise such risks and the proposed studies for learning more [Dimethyl fumarate] 120 mg & 240 mg gastro-resistant hard capsules, 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 addition to these measures, information about adverse reactions is collected continuously and regularly analysed so that immediate action can be taken necessary. These measures constitute routine pharmacovigilance activities.
If important information that may affect the safe use of [Dimethyl fumarate] 120 mg & 240 mg gastro-resistant hard capsules is not yet available, it is listed under ‘missing information’ below.
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II. A List of important risks and missing information
Important risks of [Dimethyl fumarate] 120 mg & 240 mg gastro-resistant hard capsules 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 [Dimethyl fumarate] 120 mg & 240 mg gastro-
resistant hard capsules. 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 |
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| Important potential risks |
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| Missing information |
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PML: Progressive Multifocal Leukoencephalopathy; GI: Gastrointestinal
II.B Summary of important risks
The safety information in the proposed product information is aligned to the reference medicinal product.
II.C Post-authorisation development plan
II.C.1 Studies which are conditions of the marketing authorisation
There are no studies which are conditions of the marketing authorisation or specific obligation of [Dimethyl fumarate] 120 mg & 240 mg gastro-resistant hard capsules.
II.C.2 Other studies in post-authorisation development plan
There are no studies required for [Dimethyl fumarate] 120 mg & 240 mg gastro-resistant hard capsules.
Risk Management Plan
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