Zusammenfassung der Merkmale des Arzneimittels - Dutilox 120 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)
Dutilox 120 mg magensaftresistente Hartkapseln
Administrative Information:
| Wirkstoff | Duloxetinhydrochlorid |
| ATC-Code | N06AX21 |
| Darreichungsform | magensaftresistente Hartkapsel |
| Art der Anwendung | zum Einnehmen |
| Inhaber der Zulassung | Symphar Sp. z o.o. ul. Koszykowa 65 00–667 WARSZAWA Polen |
| Zulassungsnummer | 7011570.00.00 |
| Datum der Zulassung | 22.09.2023 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 1.2 / 10.08.2023 |
| Datum der Genehmigung des RMPs | 22.09.2023 |
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 30. Oktober 2023 veröffentlicht.
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Risk Management Plan Symphar Sp. z o.o.
Dutilox 120 mg, gastro-resistant capsules, hard
Part VI: Summary of the risk management plan
Summary of risk management plan for
This is a summary of the risk management plan (RMP) for Dutilox 120 mg, gastro-resistant capsules, hard. The RMP details important risks of Dutilox 120 mg, gastro-resistant capsules, hard how these risks will be minimised, and how more information will be obtained about Dutilox 120 mg, gastro-resistant capsules, hard risks and uncertainties (missing information).
Dutilox 120 mg, gastro-resistant capsules, hard summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Dutilox 120 mg, gastro-resistant capsules, hard should be used.
Important new concerns or changes to the current ones will be included in updates of Dutilox 120 mg, gastro-resistant capsules, hard.
I. The medicine and what it is used for
Dutilox 120 mg, gastro-resistant capsules, hard is authorised for treatment of major depressive disorder and generalised anxiety disorder. It contains duloxetine (in the form of duloxetine hydrochloride) as an active substance and it is given orally.
II. Risks associated with the medicine and activities to minimise or further characterise the risks
Important risks of Dutilox 120 mg, gastro-resistant capsules, hard together with measures to minimise such risks and the proposed studies for learning more about Dutilox 120 mg, gastro-resistant capsules, hard 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.
Risk Management Plan
Symphar Sp. z o.o.
Dutilox 120 mg, gastro-resistant capsules, hard
II.A List of important risks and missing information
Important risks of Dutilox 120 mg, gastro-resistant capsules, hard 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 Dutilox 120 mg, gastro-resistant capsules, hard. 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 | Suicidality |
| Important potential risks | None |
| Missing information | None |
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 Dutilox 120 mg, gastro-resistant capsules, hard.