Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete - Dimethylfumarat Genepharm 120 mg magensaftresistente Hartkapseln
c@3 genepharm
Summary of safety concerns
| 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 |
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/Genepharm.
II.C.2 Other studies in post-authorisation development plan
There are no studies required for Dimethyl fumarate/Genepharm.
Rev.2 accompanying GVP Module V Rev.2
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