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Human medicines European public assessment report (EPAR): Zutectra, human hepatitis B immunoglobulin, Date of authorisation: 30/11/2009, Revision: 19, Status: Authorised
1 day ago
Human medicines European public assessment report (EPAR): Zutectra, human hepatitis B immunoglobulin...
Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 18, Status: Authorised
1 day ago
Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil...
Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, efavirenz,emtricitabine,tenofovir disoproxil, Date of authorisation: 05/09/2017, Revision: 19, Status: Authorised
1 day ago
Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, efavirenz,emtricitabine,tenofovir disoproxil...
Human medicines European public assessment report (EPAR): Sugammadex Mylan, sugammadex, Date of authorisation: 15/11/2021, Revision: 7, Status: Authorised
1 day ago
Human medicines European public assessment report (EPAR): Sugammadex Mylan, sugammadex, Date of...
Human medicines European public assessment report (EPAR): Fulvestrant Mylan, fulvestrant, Date of authorisation: 08/01/2018, Revision: 8, Status: Authorised
1 day ago
Human medicines European public assessment report (EPAR): Fulvestrant Mylan, fulvestrant, Date of...
Regulatory Perspectives on Herbal Medicinal / Botanical Drug Product Development: Joint FDA / EMA Workshop, Online, from 25 September 2026, 10:00 (CEST) to 25 September 2026, 13:00 (CEST)
1 day ago
Regulatory Perspectives on Herbal Medicinal / Botanical Drug Product Development: Joint FDA...
Regulatory Perspectives on Herbal Medicinal Botanical Drug Product Development - Joint FDA-EMA Workshop: Event agenda
1 day ago
Regulatory Perspectives on Herbal Medicinal Botanical Drug Product Development - Joint FDA-EMA...
Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for Identification of Medicinal Products (IDMP) in Europe: Registration requirements to public PMS API (beta release) - Chapter 1, Annex B
1 day ago
Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO)...
Product Management Service (PMS) User Acceptance Testing (UAT) Application Programming Interface (API) registration process for industry - Chapter 1, Annex A
1 day ago
Product Management Service (PMS) User Acceptance Testing (UAT) Application Programming Interface (API)...
Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1: Registration requirements for production environments
1 day ago
Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO)...