Zusammenfassung der Merkmale des Arzneimittels - Amifampridin Koanaa 10 mg Tabletten
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 | Amifampridinphosphat |
| ATC-Code | N07XX05 |
| Darreichungsform | Tablette |
| Art der Anwendung | zum Einnehmen |
| Inhaber der Zulassung | Koanaa Healthcare Spain S.L. CM de Can Camps, 17–19, KIBO Building 2H 08174 SANT CUGAT DEL VALLES Spanien |
| Zulassungsnummer | 7010379.00.00 |
| Datum der Zulassung | 08.01.2024 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 0.1 / 07.07.2022 |
| Datum der Genehmigung des RMPs | 08.01.2024 |
Der im Folgenden wiedergegebene Ausschnitt des Risikomanagement-Plans (RMP) des o. g. Arzneimittels 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 dieses Arzneimittel so sicher wie möglich angewendet wird.
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. Arzneimittel 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. Februar 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 amifampridine koanaa 10 mg tablets. The RMP details important risks of amifampridine koanaa 10 mg tablets, how these risks can be minimised, and how more information will be obtained about amifampridine koanaa’s risks and uncertainties (missing information).
Amifampridine koanaa 10 mg tablets summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how amifampridine koanaa 10 mg tablets should be used.
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. It contains amifampridine as the active substance and it is given orally as tablet.
Important risks of amifampridine koanaa 10 mg tablets, together with measures to minimise such risks and the proposed studies for learning more about amifampridine koanaa 10 mg tablets 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 are 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, including PSUR assessment so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.
If important information that may affect the safe use of amifampridine is not yet available, it is listed under ‘missing information’ below.
II.A List of important risks and missing information
Important risks of amifampridine koanaa 10 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 amifampridine koanaa 10 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).
List of important risks and missing information
| Important identified risks | Seizures |
| Food-drug interaction | |
| Important potential risks | Movement disorders |
| Cardiac toxicity including QTc prolongation | |
| Peripheral vascular disorders/Raynaud's phenomenon | |
| Respiratory disorders including bronchospasm | |
| Hepatotoxicity | |
| Serious gastrointestinal conditions | |
| Risk of nerve sheath tumour development (Schwannoma in rats) | |
| Missing information | Limited information on use in patients with renal impairment |
| Lack of information on use in patients with hepatic disease | |
| Lack of information on use during pregnancy and lactation | |
| Lack of information on potential drug-drug interactions (DDI) (including QTc prolonging drugs, seizure threshold reducing drugs, atropinic and cholinergic drugs, and depolarizing and non-depolarizing muscle relaxants) | |
| Lack of photosafety data |
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 for amifampridine koanaa 10 mg tablets.