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7 Current news of Swissmedic Schweizerisches Heilmittelinstitut
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Novartis gains approval for Gilenya as a first-line disease modifying oral therapy for multiple sclerosis in Switzerland and Australia
01-26-2011
Swissmedic, the Swiss Agency for Therapeutic Products, and the Australian Therapeutic Goods Administration (TGA) have granted approval for Gilenya® (fingolimod) 0.5 mg as a first-line, oral disease-modifying therapy (DMT) for the treatment of relapsing-remitting multiple sclerosis ...
Discontinuation of sale of ceftobiprole in Switzerland
09-13-2010
Basilea Pharmaceutica Ltd. announces that Janssen-Cilag AG, a Johnson & Johnson company, will be discontinuing sale of ceftobiprole (Zevtera(TM)) for the treatment of complicated skin and soft tissue infections (cSSTI) in Switzerland. Janssen-Cilag AG, the holder of the Marketing ...
Novartis drug Tasigna approved in Switzerland after fast-track review for treatment of patients with newly diagnosed Ph+ CML
08-31-2010
Swissmedic has granted approval for Tasigna® (nilotinib) 300 mg twice daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Tasigna is the first new therapeutic option for newly diagnosed patients ...
Swiss authorities grant product approval for Intercell's IXIARO
Vaccine to help prevent Japanese Encephalitis now available in Switzerland
07-15-2010
Intercell AG announced that Swissmedic has approved IXIARO®,its vaccine against Japanese Encephalitis. IXIARO®, which is distributed and marketed by Novartis, is now available in Switzerland. The decision by the Swiss authorities represents another important milestone for the licensure ...
Swissmedic accepts Santhera's filing of SNT-MC17 in Friedreich's Ataxia
10-05-2007
Santhera Pharmaceuticals and Takeda Pharma AG announced that Swissmedic has accepted the filing of an application for authorization for Santhera's lead compound SNT-MC17 for the treatment of Friedreich's Ataxia (FRDA). SNT-MC17 has shown clinical efficacy in FRDA patients on neurological and ...
Basilea: Submission of marketing authorization application for Alitretinoin to Swiss regulatory authority
10-02-2007
Basilea Pharmaceutica Ltd. announced the submission of a marketing authorization application to Swissmedic for its investigational drug alitretinoin. The submission supports the proposed use of oral alitretinoin in severe refractory chronic hand eczema. Basilea also announced the appointment ...
Swiss Regulatory Authority Grants Accelerated Assessment of Planned Market Authorization Application for Ceftobiprole
06-01-2007
Basilea Pharmaceutica Ltd. announced that Swissmedic granted Janssen-Cilag AG, a Johnson & Johnson company, accelerated assessment of the planned market authorization application ("Beschleunigtes Zulassungsverfahren") for ceftobiprole for the treatment of complicated skin and soft tissue ...
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