Human medicines European public assessment report (EPAR): Rasagiline ratiopharm, rasagiline, Date of authorisation: 12/01/2015, Revision: 10, Status: Authorised

Orphan designation: imetelstat sodium Treatment of myelodysplastic syndromes, 27/07/2020 Positive

ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b

Orphan designation: Unesbulin Treatment of soft tissue sarcoma, 10/12/2021 Withdrawn

Orphan designation: Lactobacillus plantarum Treatment of amyotrophic lateral sclerosis, 16/12/2019 Withdrawn

Orphan designation: Alrefimotide acetate,riletamotide acetate,tapderimotide acetate Treatment of mesothelioma, 21/03/2024 Withdrawn

Orphan designation: Glofitamab Treatment of diffuse large B-cell lymphoma, 15/10/2021 Withdrawn

Human medicines European public assessment report (EPAR): Kentera (previously Oxybutynin Nicobrand), oxybutynin, Date of authorisation: 15/06/2004, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Azilect, rasagiline, Date of authorisation: 21/02/2005, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Evrenzo, roxadustat, Date of authorisation: 18/08/2021, Revision: 6, Status: Authorised