Any data generated within the Medical Need Program will only be used in the scope of pharmacovigilance. Only one indication can be envisaged per program. DRUG ELIGIBILITY CRITERIA FOR THIS MEDICAL NEED PROGRAM Medical need programs relate by nature to products that are authorized in Belgium for which: the sought indication has been obtained but the product is not yet commercially available in Belgium, or a demand to obtain the sought indication is in process, or clinical trials are ongoing in the sought indication and/or results are relevant for the scope of the Medical need program . RECOMMANDATIONS The applicant should describe what are the international clinical guidelines recommendations in the indication of the program. PATIENTS ELIGIBILITY CRITERIA FOR THIS MEDICAL NEED PROGRAM Inclusion/Exclusion criteria As mandatory inclusion criteria : The patient is not eligible for a clinical running with Product name and/or a clinical trial running in the envisaged indication of this program. The patient cannot be satisfactorily treated with the approved and commercially available alternative treatments, in accordance with clinical guidelines, because of efficacy and/or safety issues. It is recommended to the Inclusion/Exclusion criteria with the SmPC recommendations. An overview of relevant clinical trials ongoing in Belgium in the envisaged indication with Product name or with another product should be provided (see the table below). For each trial it should be commented whether the patient population of the Medical Need Program is (partly) eligible for inclusion in that trial. In case running clinical trials in the same indication are identified, and the patient population of the program with an unmet medical need is eligible for such trials, the existence of these trials must be clearly communicated to the treating physicians involved in the MNP as part of the MNP documentation and patients must be offered first the possibility to participate in the concerned trials. Amongst others, relevant sources are and . Patient EudraCT Number Title of clinical trial Phase Indication population of MNP
Any data generated within the Medical Need Program will only be used in the scope of pharmacovigilance. Only one indication can be envisaged per program. DRUG ELIGIBILITY CRITERIA FOR THIS MEDICAL NEED PROGRAM Medical need programs relate by nature to products that are authorized in Belgium for which: the sought indication has been obtained but the product is not yet commercially available in Belgium, or a demand to obtain the sought indication is in process, or clinical trials are ongoing in the sought indication and/or results are relevant for the scope of the Medical need program . RECOMMANDATIONS The applicant should describe what are the international clinical guidelines recommendations in the indication of the program. PATIENTS ELIGIBILITY CRITERIA FOR THIS MEDICAL NEED PROGRAM Inclusion/Exclusion criteria As mandatory inclusion criteria : The patient is not eligible for a clinical running with Product name and/or a clinical trial running in the envisaged indication of this program. The patient cannot be satisfactorily treated with the approved and commercially available alternative treatments, in accordance with clinical guidelines, because of efficacy and/or safety issues. It is recommended to the Inclusion/Exclusion criteria with the SmPC recommendations. An overview of relevant clinical trials ongoing in Belgium in the envisaged indication with Product name or with another product should be provided (see the table below). For each trial it should be commented whether the patient population of the Medical Need Program is (partly) eligible for inclusion in that trial. In case running clinical trials in the same indication are identified, and the patient population of the program with an unmet medical need is eligible for such trials, the existence of these trials must be clearly communicated to the treating physicians involved in the MNP as part of the MNP documentation and patients must be offered first the possibility to participate in the concerned trials. Amongst others, relevant sources are and . EudraCT Number Title of clinical trial Phase Indication Patient population of MNP
mnp_protocol_v1.4_definitive.docx