Manufacturers, importers and distributors of human and veterinary medicines must check their data in the Organisation Management Service database of the EMA

From 28 January 2022, new regulations will come into force for manufacturers, importers and distributors of medicines for human and veterinary use. The FAMHP is asking them to check from 28 January 2022 onwards whether their organisation's data are correctly registered in the Organisation Management Service of the European Medicines Agency (EMA).

Give your opinion on a genetically modified medicine for the treatment of Duchenne muscular dystrophy

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine SRP-9001 for the treatment of Duchenne muscular dystrophy. The public consultation runs from 17 January 2022 to 16 February 2022.

Give your opinion on a genetically modified medicine for the treatment of various types of advanced cancer

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial testing the genetically modified oncolytic virus VSV-GP (BI 1831169), for the treatment of patients with various types of advanced cancer (solid tumours). The public consultation runs from 11 January 2022 to 10 February 2022.

Otezla

Active substance apremilast
Holder Amgen
Status Running
Indication Treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy. The patient has received prior treatment with a topical therapy AND with colchicine.

Tecartus

Active substance autologous anti-CD19 CD3+ cells (CAR+ viable T cells)
Holder     Gilead Sciences Belgium bv
Status Running
Indication treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton's tyrosine kinase (BTK) inhibitor
Public documents

Limited availability of RoActemra (Roche): new situation update

The availability of RoActemra (tocilizumab), a drug used for certain rheumatological and hematological disorders, can still not be fully guaranteed. Currently, there is a stock for both the intravenous and subcutaneous form of administration, taking into account the previously approved indications, i.e. exclusive use in COVID-19 patients. Based on the information currently available to the FAMHP, Roche will also not be able to confirm deliveries long in advance in the coming months.

PRAC December 2021 – Assessment of recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax

During the December 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has assessed recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax.
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