Latest Biotechnology, Pharmaceutical and Healthcare News from European Medicines Agency

Veterinary medicine European Public Assessment Report (EPAR): Equilis Prequenza Te, vaccine against equine influenza and tetanus in horses, Revision: 7, Authorised

Veterinary medicine European Public Assessment Report (EPAR): Equilis Prequenza, vaccine against equine influenza in horses, Revision: 7, Authorised

Human medicines European Public Assessment Report (EPAR): Eliquis, apixaban, Revision: 2, Authorised

Human medicines European Public Assessment Report (EPAR): Helicobacter Test INFAI, 13C-urea, Revision: 11, Authorised

Human medicines European Public Assessment Report (EPAR): Dificlir, fidaxomicin, Revision: 3, Authorised

News and press releases: European Medicines Agency issues six key recommendations to tackle the issue of medication errors

The European Medicines Agency (EMA) has issued six key recommendations to tackle the issue of medication errors causing harm in the European Union (EU).

News and press releases: eSubmission Gateway or web client to become mandatory for all eCTD submissions through the centralised procedure in 2014

From 1 March 2014, the use of the eSubmission Gateway or web client will become mandatory for all electronic Common Technical Document (eCTD) submissions through the centralised procedure.

Human medicines European Public Assessment Report (EPAR): Maruxa, memantine, Revision: 0, Authorised

Human medicines European Public Assessment Report (EPAR): Prepandrix, prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted), Revision: 7, Authorised

Human medicines European Public Assessment Report (EPAR): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), irbesartan / hydrochlorothiazide, Revision: 16, Authorised

Human medicines European Public Assessment Report (EPAR): Pumarix, pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted), Revision: 2, Authorised

Human medicines European Public Assessment Report (EPAR): Soliris, eculizumab, Revision: 9, Authorised

Human medicines European Public Assessment Report (EPAR): Thalidomide Celgene (previously Thalidomide Pharmion), thalidomide, Revision: 14, Authorised

Veterinary medicine European Public Assessment Report (EPAR): Cerenia, maropitant citrate, Revision: 11, Authorised

Human medicines European Public Assessment Report (EPAR): Tandemact, pioglitazone / glimepiride, Revision: 9, Authorised

Human medicines European Public Assessment Report (EPAR): Karvezide, irbesartan / hydrochlorothiazide, Revision: 28, Authorised

Human medicines European Public Assessment Report (EPAR): Zometa, zoledronic acid, Revision: 19, Authorised

Human medicines European Public Assessment Report (EPAR): Competact, pioglitazone / metformin, Revision: 11, Authorised

Human medicines European Public Assessment Report (EPAR): Irbesartan/Hydrochlorothiazide Teva, irbesartan / hydrochlorothiazide, Revision: 5, Authorised

Human medicines European Public Assessment Report (EPAR): Bydureon, exenatide, Revision: 1, Authorised

Human medicines European Public Assessment Report (EPAR): Signifor, pasireotide, Revision: 1, Authorised

News and press releases: European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics

Following the conclusion of the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of Diane 35 and its generics outweigh the risks in a specific patient group, the French National Agency for the Safety of Medicine and Health Product...

News and press releases: International Clinical Trials Day: 20 May 2013

The European Medicines Agency supports International Clinical Trials Day, which is taking place on Monday 20 May 2013.

Human medicines European Public Assessment Report (EPAR): Lyrica, pregabalin, Revision: 22, Authorised

Human medicines European Public Assessment Report (EPAR): Neulasta, pegfilgrastim, Revision: 19, Authorised