European marketing authorisation

ERYTECH Announces Withdrawal of Its European Marketing Authorization Application for GRASPA.

Cardiome Announces The Transfer Of European Marketing

Genmab announces European marketing authorisation for Darzalex.

GlaxoSmithKline : GSK receives European marketing

Gilead Receives European Marketing Authorization for Eviplera(R), a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 Infection in Treatment-Naive Adults.

INS - GSK Receives European Marketing Authorisation to

The Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion for SpinrazaTM, a first step towards market authorisation.Blog Coverage Sunesis Pharma Withdraws European Marketing Authorization Application for Vosaroxin.

European reflections on reviewing NDAs and ANDAs for ICH Q3D elemental impurity compliance.April 16, 2014 — Navidea Biopharmaceuticals Inc. held an update meeting with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines.The FDA granted Breakthrough Therapy designation for Kanuma for LAL Deficiency presenting in infants and accepted the Kanuma BLA for Priority Review.Marketing authorisation, decentralised procedure, national authorization, european reference, EU regulatory filling.

Genmab Announces European Marketing Authorization for

European Medicines Agency - Paediatric medicines

In order to obtain a marketing authorisation by the European Commission for a product to.Genmab announced today that the European Commission has granted a marketing authorization for.

There are three procedures by which a marketing authorisation in EU can be obtained, Centralised Procedure which is compulsory.

European Medicines Agency - Orphan medicines

Merck and Endocyte Announce Acceptance for Review of European Marketing Authorization Applications for Vintafolide and Companion Diagnostic Etarfolatide for Folate.

Genmab announces European marketing authorisation for

SCENESSE® attains historic breakthrough European Marketing

Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency.The decision follows the June 2015 positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP).

Finox Biotech’s bemfola gets European marketing

European Drug Law Summary Marketing Authorizations

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LAL-D affects patients of all ages with clinical manifestations from infancy through adulthood and may have sudden and unpredictable clinical complications.Elanco, a division of Eli Lilly and Company, provides comprehensive products and knowledge services to improve animal health and food-animal production in more than 70 countries around the world.

Theratechnologies Announces Filing of European Marketing

Kanuma, an innovative ERT, is the first approved treatment in the European Union for patients with LAL-D, a genetic and progressive ultra-rare metabolic disease in which patients suffer multi-organ damage and premature death.Janssen Submits European Marketing Authorisation Application for Canagliflozin in Type 2 Diabetes.

In pediatric and adult patients with LAL-D, treatment with Kanuma resulted in normalization of ALT, reduction in liver fat content and other markers of liver injury compared to placebo, as well as significant improvements in lipid accumulation as measured by LDL-C and HDL-C.This is sent to the European Commission to be transformed into a marketing authorisation valid for the whole of the EU.

ERYTECH Announces Withdrawal of Its European Marketing

Marketing authorization to european union - PdfSR.com

Genmab A/S Announces European Marketing Authorization For

Basilea submits European Marketing Authorization Application of ceftobiprole for the treatment of pneumonia.

RESULTS Results show that cumulative 8-years expenditure for 90 orphan drugs in Slovakia with European orphan designation and European marketing authorisation by date.GSK, Fondazione Telethon and Ospedale San Raffaele gain approval to provide life-saving gene therapy to patients.

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Regulated information 1 July, 2014 European Medicines Agency renews Marketing Authorisation for ChondroCelect Leuven (BELGIUM) - 1 July, 2014 -TiGenix NV.

Infants experience profound growth failure, liver fibrosis, and cirrhosis with a median age of death at 3.7 months.Pfizer said that The European Commission granted European marketing authorization for its pneumococcal conjugate vaccine, Prevenar 13 (Pneumococcal Polysaccharide.European Drug Law Summary Marketing Authorizations: Innovator Drugs and Biologics. when an marketing authorization.

Signs and symptoms included chest discomfort, conjunctival injection, dyspnea, generalized and itchy rash, hyperemia, mild eyelid edema, rhinorrhea, severe respiratory distress, tachycardia, tachypnea and urticaria.VELCADE (Bortezomib) receives European marketing authorisation First new cancer treatment for multiple myeloma in a decade.