Beipackzettel - Amifampridin Koanaa 10 mg Tabletten
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)
Amifampridin Koanaa 10 mg Tabletten
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
Summary of risk management plan for Amifampridine Koanaa 10 mg tablets (Amifampridine)
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.
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I. The medicine and what it is used for
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. It contains amifampridine as the active substance and it is given orally as tablet.
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II. Risks associated with the medicine and activities to minimise or further characterise the risks
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.
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II.A List of important risks and missing information