Beipackzettel - Cytisiniclin APC Pharmlog
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)
Cytisiniclin APC Pharmlog
Administrative Information:
| Wirkstoff | Cytisiniclin |
| ATC-Code | N07BA04 |
| Darreichungsform | Filmtablette |
| Art der Anwendung | zum Einnehmen |
| Inhaber der Zulassung | APC Pharmlog Sp. z.o.o. ul. Aleje Jerozolimskie 146C 02–305 WARSAW Polen |
| Zulassungsnummer | 7005525.00.00 |
| Datum der Zulassung | 14.05.2023 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 0.3 / 15.11.2022 |
| Datum der Genehmigung des RMPs | 14.05.2023 |
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 21. Juni 2023 veröffentlicht.
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Part VI: Summary of the risk management plan
Summary of risk management plan for Cytisinicline APC Pharmlog ( Cytisinicline )
This is a summary of the risk management plan (RMP) for Cytisinicline APC Pharmlog. The RMP details important risks of Cytisinicline APC Pharmlog, how these risks can be minimised, and how more information will be obtained about Cytisinicline APC Pharmlog’s risks and uncertainties (missing information).
Cytisinicline APC Pharmlog’s summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Cytisinicline APC Pharmlog should be used.
Important new concerns or changes to the current ones will be included in updates of Cytisinicline APC Pharmlog’s RMP.
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I. The medicine and what it is used for
The indication of the medical product Cytisinicline APC Pharmlog is smoking cessation and reduction of nicotine cravings in adult smokers who are willing to stop smoking. The treatment goal of Cytisinicline APC Pharmlog is the permanent cessation of nicotine-containing products use (see SmPC for the full indication).
It contains cytisinicline as the active substance and it is given by oral route of administration.
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II. Risks associated with the medicine and activities to minimise or further characterise the risks
Important risks Cytisinicline APC Pharmlog, together with measures to minimise such risks and the proposed studies for learning more about Cytisinicline APC Pharmlog 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 addition to these measures, information about adverse reactions is collected continuously and regularly analysed so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.
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II. A List of important risks and missing information
Important risks of Cytisinicline APC Pharmlog 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 Cytisinicline APC Pharmlog. 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).
| Summary of safety concerns | ||
| Important identified risks | | None |
| 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 Cytisinicline APC Pharmlog.
II.C.2 Other studies in post-authorisation development plan
There are no studies required for Cytisinicline APC Pharmlog.
Page 10 of 13
Risk Management Plan: CytisiniclineRX0.3
RD-106/13
DC/PL+5/1