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Last updated 2 days ago
Validation checklist for Type II (non) clinical variations
2 days ago
Validation checklist for Type II (non) clinical variations
Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union
3 days ago
Obtaining and maintaining a scientific opinion on a medicine for use outside...
Referral: Tecovirimat SIGA, tecovirimat Article 20 procedures Under evaluation, 30/01/2026
3 days ago
Referral: Tecovirimat SIGA, tecovirimat Article 20 procedures Under evaluation, 30/01/2026
Human medicines European public assessment report (EPAR): Osvyrti, denosumab, Date of authorisation: 26/05/2025, Revision: 1, Status: Authorised
3 days ago
Human medicines European public assessment report (EPAR): Osvyrti, denosumab, Date of authorisation...
Human medicines European public assessment report (EPAR): Trisenox, arsenic trioxide, Date of authorisation: 05/03/2002, Revision: 33, Status: Authorised
3 days ago
Human medicines European public assessment report (EPAR): Trisenox, arsenic trioxide, Date of...
Human medicines European public assessment report (EPAR): Lenvima, lenvatinib, Date of authorisation: 28/05/2015, Revision: 27, Status: Authorised
3 days ago
Human medicines European public assessment report (EPAR): Lenvima, lenvatinib, Date of authorisation...
Use of Bayesian methods in clinical development - Scientific guideline
3 days ago
Use of Bayesian methods in clinical development - Scientific guideline
Concept paper for the development of a reflection paper on the use of Bayesian methods in clinical development
3 days ago
Concept paper for the development of a reflection paper on the use...
Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 27, Status: Authorised
3 days ago
Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation...
Concept paper on the revision of the guideline on clinical evaluation of diagnostic agents and its appendix 1 on imaging agents
3 days ago
Concept paper on the revision of the guideline on clinical evaluation of...