Adifemu 120 mg - Zusammengefasste Informationen

Zusammenfassung des Risikomanagement-Plans gemäß § 34Zusammenfassung 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 mgAdifemu 120 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.

(1)

(2)

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.

II.    Risks associated with the medicine and activities to minimise or further characterise the risksII. 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.

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	PML Decreases in leukocyte and lymphocyte counts Drug-induced liver injury
Important potential risks	Serious and opportunistic infections (other than PML and herpes zoster) Malignancies Effects on pregnancy outcome Interaction with nephrotoxic medications leading to renal toxicity
Missing information	Long term efficacy and safety Safety profile in patients over the age of 55 years Safety profile in patients with moderate to severe renal impairment Safety profile in patients with hepatic impairment Safety profile in patients with severe active GI disease Increased risk of infection in patients concomitantly taking anti-neoplastic or immunosuppressive therapies

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.