| European Federation of Internal Medicine

European Immunization Week 2018- Statement of Guido Rasi, Executive Director, European Medicines Agency

Posted on: 26/04/2018 - 13:27

Vaccines matter for each of us: yearly, they prevent 2.7 million people from contracting measles, one million from getting whooping cough and two million babies from getting tetanus. They eradicated smallpox. They stopped polio, a dreadful disease affecting millions of children, in almost all... more

Field of Interest: European Union Medical News

Type: News Feed

Medicines for human use under evaluation

Submitted by Anonymous (not verified) on 18 November 2025 - 16:19

Medicines for human use under evaluation

Read more about Medicines for human use under evaluation

Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (17 October - 13 November 2025)

Submitted by Anonymous (not verified) on 18 November 2025 - 16:16

Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (17 October - 13 November 2025)

Read more about Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (17 October - 13 November 2025)

Start of procedure: Extension of marketing authorisation (17 October - 13 November 2025)

Submitted by Anonymous (not verified) on 18 November 2025 - 16:08

Start of procedure: Extension of marketing authorisation (17 October - 13 November 2025)

Read more about Start of procedure: Extension of marketing authorisation (17 October - 13 November 2025)

Human medicines European public assessment report (EPAR): Viread, tenofovir disoproxil, Date of authorisation: 04/02/2002, Revision: 61, Status: Authorised

Submitted by Anonymous (not verified) on 18 November 2025 - 15:56

Human medicines European public assessment report (EPAR): Viread, tenofovir disoproxil, Date of authorisation: 04/02/2002, Revision: 61, Status: Authorised

Read more about Human medicines European public assessment report (EPAR): Viread, tenofovir disoproxil, Date of authorisation: 04/02/2002, Revision: 61, Status: Authorised

Human medicines European public assessment report (EPAR): Hirobriz Breezhaler, indacaterol, Date of authorisation: 30/11/2009, Revision: 21, Status: Authorised

Submitted by Anonymous (not verified) on 18 November 2025 - 15:40

Human medicines European public assessment report (EPAR): Hirobriz Breezhaler, indacaterol, Date of authorisation: 30/11/2009, Revision: 21, Status: Authorised

Read more about Human medicines European public assessment report (EPAR): Hirobriz Breezhaler, indacaterol, Date of authorisation: 30/11/2009, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Oslif Breezhaler, indacaterol, Date of authorisation: 29/11/2009, Revision: 20, Status: Authorised

Submitted by Anonymous (not verified) on 18 November 2025 - 15:35

Human medicines European public assessment report (EPAR): Oslif Breezhaler, indacaterol, Date of authorisation: 29/11/2009, Revision: 20, Status: Authorised

Read more about Human medicines European public assessment report (EPAR): Oslif Breezhaler, indacaterol, Date of authorisation: 29/11/2009, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR): Onbrez Breezhaler, indacaterol, Date of authorisation: 29/11/2009, Revision: 20, Status: Authorised

Submitted by Anonymous (not verified) on 18 November 2025 - 15:33

Human medicines European public assessment report (EPAR): Onbrez Breezhaler, indacaterol, Date of authorisation: 29/11/2009, Revision: 20, Status: Authorised

Read more about Human medicines European public assessment report (EPAR): Onbrez Breezhaler, indacaterol, Date of authorisation: 29/11/2009, Revision: 20, Status: Authorised

Workshop on the use of external controls for evidence generation in regulatory decision-making, Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 November 2025, 10:00 (CET) to 3 November 2025, 17:30 (CET)

Submitted by Anonymous (not verified) on 18 November 2025 - 15:30

Workshop on the use of external controls for evidence generation in regulatory decision-making, Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 November 2025, 10:00 (CET) to 3 November 2025, 17:30 (CET)

Read more about Workshop on the use of external controls for evidence generation in regulatory decision-making, Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 November 2025, 10:00 (CET) to 3 November 2025, 17:30 (CET)

Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, efavirenz,emtricitabine,tenofovir disoproxil, Date of authorisation: 05/09/2017, Revision: 18, Status: Authorised

Submitted by Anonymous (not verified) on 18 November 2025 - 15:18

Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, efavirenz,emtricitabine,tenofovir disoproxil, Date of authorisation: 05/09/2017, Revision: 18, Status: Authorised

Read more about Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, efavirenz,emtricitabine,tenofovir disoproxil, Date of authorisation: 05/09/2017, Revision: 18, Status: Authorised

European Immunization Week 2018- Statement of Guido Rasi, Executive Director, European Medicines Agency

Medicines for human use under evaluation

Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (17 October - 13 November 2025)

Start of procedure: Extension of marketing authorisation (17 October - 13 November 2025)

Human medicines European public assessment report (EPAR): Viread, tenofovir disoproxil, Date of authorisation: 04/02/2002, Revision: 61, Status: Authorised

Human medicines European public assessment report (EPAR): Hirobriz Breezhaler, indacaterol, Date of authorisation: 30/11/2009, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Oslif Breezhaler, indacaterol, Date of authorisation: 29/11/2009, Revision: 20, Status: Authorised

Human medicines European public assessment report (EPAR): Onbrez Breezhaler, indacaterol, Date of authorisation: 29/11/2009, Revision: 20, Status: Authorised

Workshop on the use of external controls for evidence generation in regulatory decision-making, Online, European Medicines Agency, Amsterdam, the Netherlands, from 3 November 2025, 10:00 (CET) to 3 November 2025, 17:30 (CET)

Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, efavirenz,emtricitabine,tenofovir disoproxil, Date of authorisation: 05/09/2017, Revision: 18, Status: Authorised

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