What's new

What's new

Human medicines European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau), chenodeoxycholic acid, Date of authorisation: 10/04/2017, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau), chenodeoxycholic acid, Date of authorisation: 10/04/2017, Revision: 7, Status: Authorised

13 August 2025

Human medicines European public assessment report (EPAR): Enbrel, etanercept, Date of authorisation: 02/02/2000, Revision: 76, Status: Authorised

Human medicines European public assessment report (EPAR): Enbrel, etanercept, Date of authorisation: 02/02/2000, Revision: 76, Status: Authorised

13 August 2025

List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2025

List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animal and humans to veterinary medicinal products for 2025

12 August 2025

Human medicines European public assessment report (EPAR): Dazublys, trastuzumab, Date of authorisation: 30/06/2025, Status: Authorised

Human medicines European public assessment report (EPAR): Dazublys, trastuzumab, Date of authorisation: 30/06/2025, Status: Authorised

12 August 2025

Good agricultural and collection practice for starting materials of herbal origin - Scientific guideline

Good agricultural and collection practice for starting materials of herbal origin - Scientific guideline

12 August 2025

Combined VeDDRA list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products

Combined VeDDRA list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products

12 August 2025

Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine, Date of authorisation: 06/01/2021, Revision: 56, Status: Authorised

Human medicines European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna), COVID-19 mRNA vaccine, Date of authorisation: 06/01/2021, Revision: 56, Status: Authorised

12 August 2025

Human medicines European public assessment report (EPAR): Nurzigma, pridopidine, Status: Opinion under re-examination

Human medicines European public assessment report (EPAR): Nurzigma, pridopidine, Status: Opinion under re-examination

12 August 2025

Human medicines European public assessment report (EPAR): Dyrupeg, pegfilgrastim, Date of authorisation: 28/03/2025, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Dyrupeg, pegfilgrastim, Date of authorisation: 28/03/2025, Revision: 3, Status: Authorised

12 August 2025

Human medicines European public assessment report (EPAR): Comirnaty, COVID-19 mRNA vaccine,tozinameran,riltozinameran and tozinameran,famtozinameran and tozinameran,raxtozinameran, Date of authorisation: 21/12/2020, Revision: 54, Status: Authorised

Human medicines European public assessment report (EPAR): Comirnaty, COVID-19 mRNA vaccine,tozinameran,riltozinameran and tozinameran,famtozinameran and tozinameran,raxtozinameran, Date of authorisation: 21/12/2020, Revision: 54, Status: Authorised

12 August 2025