Dates of 2027 SAWP meetings and submission deadlines Scientific advice, protocol assistance, qualification of biomarkers and parallel HTACG/EMA Joint Scientific Consultation requests

Dates of 2027 SAWP meetings and submission deadlines Scientific advice, protocol assistance, qualification of biomarkers and parallel HTACG/EMA Joint Scientific Consultation requests

Template - Request for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004' to be replaced by 'Briefing Note and Recommendations on a Request for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004

Template - Request for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004' to be replaced by 'Briefing Note and Recommendations on a Request for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004

Human medicines European public assessment report (EPAR): Sylvant, siltuximab, Date of authorisation: 22/05/2014, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Sylvant, siltuximab, Date of authorisation: 22/05/2014, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR): Privigen, human normal immunoglobulin (IVIg), Date of authorisation: 24/04/2008, Revision: 34, Status: Authorised

Human medicines European public assessment report (EPAR): Privigen, human normal immunoglobulin (IVIg), Date of authorisation: 24/04/2008, Revision: 34, Status: Authorised

Human medicines European public assessment report (EPAR): Gilenya, fingolimod, Date of authorisation: 17/03/2011, Revision: 42, Status: Authorised

Human medicines European public assessment report (EPAR): Gilenya, fingolimod, Date of authorisation: 17/03/2011, Revision: 42, Status: Authorised

Concept paper on the development of a reflection paper on the non-clinical requirements for severely debilitating or life-threatening diseases

Concept paper on the development of a reflection paper on the non-clinical requirements for severely debilitating or life-threatening diseases

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