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Last updated about 15 hours ago

Validation checklist for Type II (non) clinical variations

about 18 hours ago

Validation checklist for Type II (non) clinical variations

Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union

about 19 hours ago

Obtaining and maintaining a scientific opinion on a medicine for use outside...

PSUSA/00010396/202504

about 19 hours ago

PSUSA/00010396/202504

PSUSA/00000583/202503

about 19 hours ago

PSUSA/00000583/202503

Referral: Tecovirimat SIGA, tecovirimat Article 20 procedures Under evaluation, 30/01/2026

about 19 hours ago

Referral: Tecovirimat SIGA, tecovirimat Article 20 procedures Under evaluation, 30/01/2026

Human medicines European public assessment report (EPAR): Trisenox, arsenic trioxide, Date of authorisation: 05/03/2002, Revision: 33, Status: Authorised

about 19 hours 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

about 19 hours ago

Human medicines European public assessment report (EPAR): Lenvima, lenvatinib, Date of authorisation...

Use of Bayesian methods in clinical development - Scientific guideline

about 21 hours 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

about 21 hours 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

about 21 hours 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

about 21 hours ago

Concept paper on the revision of the guideline on clinical evaluation of...

Human medicines European public assessment report (EPAR): Pemetrexed Accord, pemetrexed, Date of authorisation: 18/01/2016, Revision: 15, Status: Authorised

about 21 hours ago

Human medicines European public assessment report (EPAR): Pemetrexed Accord, pemetrexed, Date of...