We refer primarily to the information provided by the European Medicines Agency –EMEA, the European body being “responsible for the protection and promotion of public and animal health, through the evaluation, supervision and authorisation of medicines for human and veterinary use” (quote EMEA website: www.emea.europa.eu)

Where available, you are brought to the EPAR (European Public Assessment Report) and the Package Leaflet on the EMEA website providing scientifically approved and unbiased information. Within the EPAR, the "Summary for the Public" is meant for a short overview on the specific drug in understandable layman’s language, often available in all EU languages. The same applies to the "Package Leaflet", which frequent users of the drug should know anyway. More details can be found in the other parts of the EPAR, but the terminology often requires advanced medical knowledge.

The EMEA or the national competent authorities (NCA) decide on the market authorisation of any new drug in Europe. Therefore - if there is no EMEA authorisation for a specific drug – the drug information should come via the authorising NCA, provided usually in the national language(s).
Furthermore, we make reference with links to to the therapy recommendations of the Multiple Sclerosis Therapy Consensus Group published in 2004 as ”Escalating immunotherapy of multiple sclerosis- New aspects and practical application” and its updates in 2006 and in 2007.These therapy recommedations were approved by most of the leading neurologists in Europe, endorsed in 2007 the European Parliament, the European Commission and the German Health Minister and form now a substantial part of EMSP’s “European Code of Good Practice in MS”.

If you want to know more about a specific therapy, please see the table below for the list of approved DMTs for MS. In clicking on the either agent name or on the indication you will be forwarded to the relevant information provided by EMEA or by the national competent authorities.

List of approved DMTs for MS
Click on the Agent	Approved	Click on the Indication
beta interferon [IFN] 1b	FDA:1993 EU: 1997	For the treatment of relapsing forms of MS (US)and for a single clinical episode if MRI features consistent with MS are also present. For RRMS and SPMS with active disease (relapses) in EU
beta IFN 1a-intramuscular [im]	FDA: 1996 EU: 1997	For the treatment of relapsing-remitting forms of MS, and for a single clinical episode if MRI features consistent with MS are also present
glatiramer acetate	FDA:1996 EU: 2002	For the treatment of relapsing-remitting MS and for a single clinical episode if MRI features consistent with MS are also present
mitoxantrone	FDA: 2000 not approved for MS in EU	For treatment of worsening relapsing-remitting MS and for progressive-relapsing or secondary-progressive MS; 2nd line therapy
beta IFN 1a-subcutaneous [sc]	FDA: 2002 EU: 1998	For the treatment of relapsing forms of MS (US) For MS patients with 2 or more relapses in last 2 yrs (EU)
natalizumab	FDA: 2004* FDA&EU:2006	For the treatment of patients with relapsing forms of MS to reduce disability and slow progression; 2nd line therapy
* Voluntarily withdrawn from the market on 2/28/2005; US FDA March 2006 Advisory Panel recommended for re-approval

26th July 2010

IMPORTANT DISCLAIMER: The EMSP does not recommend or endorse any products produced or distributed. The EMSP is unable to make any judgment on suitability of treatment; therapies can always be initiated and supervised by qualified medical practitioners.

Please find attached:
 Escalating immunomodulatory therapy of multiple sclerosis - Current therapeutic recommendations (2008)

 All EMSP Consensus Papers (2008 03)