Minutes of the PRAC meeting 13-16 May 2024
Submitted by Anonymous (not verified) on 9 April 2025 - 10:39
Minutes of the PRAC meeting 13-16 May 2024
Human medicines European public assessment report (EPAR): Quinsair, levofloxacin, Date of authorisation: 25/03/2015, Revision: 17, Status: Authorised
Submitted by Anonymous (not verified) on 9 April 2025 - 10:26
Human medicines European public assessment report (EPAR): Quinsair, levofloxacin, Date of authorisation: 25/03/2015, Revision: 17, Status: Authorised
Human medicines European public assessment report (EPAR): Rasagiline ratiopharm, rasagiline, Date of authorisation: 12/01/2015, Revision: 10, Status: Authorised
Submitted by Anonymous (not verified) on 9 April 2025 - 9:45
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
Submitted by Anonymous (not verified) on 9 April 2025 - 9:44
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
Submitted by Anonymous (not verified) on 9 April 2025 - 9:35
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Orphan designation: Unesbulin Treatment of soft tissue sarcoma, 10/12/2021 Withdrawn
Submitted by Anonymous (not verified) on 9 April 2025 - 9:33
Orphan designation: Unesbulin Treatment of soft tissue sarcoma, 10/12/2021 Withdrawn
Orphan designation: Lactobacillus plantarum Treatment of amyotrophic lateral sclerosis, 16/12/2019 Withdrawn
Submitted by Anonymous (not verified) on 9 April 2025 - 9:30
Orphan designation: Lactobacillus plantarum Treatment of amyotrophic lateral sclerosis, 16/12/2019 Withdrawn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designation: Alrefimotide acetate,riletamotide acetate,tapderimotide acetate Treatment of mesothelioma, 21/03/2024 Withdrawn
Submitted by Anonymous (not verified) on 9 April 2025 - 9:27
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designation: Alrefimotide acetate,riletamotide acetate,tapderimotide acetate Treatment of mesothelioma, 21/03/2024 Withdrawn
Orphan designation: Glofitamab Treatment of diffuse large B-cell lymphoma, 15/10/2021 Withdrawn
Submitted by Anonymous (not verified) on 9 April 2025 - 9:23
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
Submitted by Anonymous (not verified) on 8 April 2025 - 16:15
Human medicines European public assessment report (EPAR): Kentera (previously Oxybutynin Nicobrand), oxybutynin, Date of authorisation: 15/06/2004, Revision: 23, Status: Authorised