Metformin product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 28 November 2023 - 15:21
Metformin product-specific bioequivalence guidance
Lurasidone product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 28 November 2023 - 15:17
Lurasidone product-specific bioequivalence guidance
Fampridine product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 28 November 2023 - 15:01
Fampridine product-specific bioequivalence guidance
IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants
Submitted by Anonymous (not verified) on 28 November 2023 - 15:00
IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants
Bosutinib product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 28 November 2023 - 14:58
Bosutinib product-specific bioequivalence guidance
Human medicines European public assessment report (EPAR): Zessly, infliximab, Arthritis, Psoriatic;Psoriasis;Crohn Disease;Arthritis, Rheumatoid;Colitis, Ulcerative;Spondylitis, Ankylosing, Date of authorisation: 18/05/2018, Revision: 12, Status: Authori
Submitted by Anonymous (not verified) on 28 November 2023 - 14:41
Human medicines European public assessment report (EPAR): Zessly, infliximab, Arthritis, Psoriatic;Psoriasis;Crohn Disease;Arthritis, Rheumatoid;Colitis, Ulcerative;Spondylitis, Ankylosing, Date of authorisation: 18/05/2018, Revision: 12, Status: Authorised
Lomustine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001902/202301
Submitted by Anonymous (not verified) on 28 November 2023 - 13:00
Lomustine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001902/202301
Lomustine : List of nationally authorised medicinal products - PSUSA/00001902/202301
Submitted by Anonymous (not verified) on 28 November 2023 - 12:57
Lomustine : List of nationally authorised medicinal products - PSUSA/00001902/202301
Human medicines European public assessment report (EPAR): Cyramza, ramucirumab, Stomach Neoplasms, Date of authorisation: 19/12/2014, Revision: 16, Status: Authorised
Submitted by Anonymous (not verified) on 28 November 2023 - 12:50
Human medicines European public assessment report (EPAR): Cyramza, ramucirumab, Stomach Neoplasms, Date of authorisation: 19/12/2014, Revision: 16, Status: Authorised
Bicalutamide : List of nationally authorised medicinal products - PSUSA/00000407/202302
Submitted by Anonymous (not verified) on 28 November 2023 - 12:49
Bicalutamide : List of nationally authorised medicinal products - PSUSA/00000407/202302