Berbira 120 mg magensaftresistente Hartkapseln - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

/äDALVO

always on target

• I. The medicine and what it is used for

Dimethyl Fumarate is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS) (see SmPC for the full indication). It contains dimethyl fumarate as the active substance and it is given by oral route of administration..

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

Important risks of Dimethyl Fumarate, together with measures to minimise such risks and the proposed studies for learning more about Dimethyl Fumarate's 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 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 Dimethyl Fumarate 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 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. 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

List of important risks and missing information
	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

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 dimethyl fumarate.

II.C.2 Other studies in post-authorisation development plan

There are no studies required for dimethyl fumarate.

Risk Management Plan Version

December 2022

0.4

Page 10/89