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Regulatory awareness session on medical devices (Webinar)

European Medicines Agency, Amsterdam, the Netherlands, 02/12/2019, Last updated: 22/11/2019
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Ebola (updated)

Last updated: 22/11/2019
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Human medicine European public assessment report (EPAR): Ivozall

clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/11/2019, , , Authorised, Last updated: 22/11/2019
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Ivozall : EPAR - Risk-management-plan summary (PDF/93.35 KB)

First published: 22/11/2019
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Ivozall : EPAR - Public assessment report (PDF/399.05 KB)

Adopted
First published: 22/11/2019
EMA/CHMP/585665/2019
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Ivozall : EPAR - All authorised presentations (PDF/11.59 KB)

First published: 22/11/2019
Bulgarian
(PDF/33.23 KB)

Croatian
(PDF/25.58 KB)

Czech
(PDF/28.76 KB)

Danish
(PDF/11.51 KB)

Dutch
(PDF/11.58 KB)

Estonian
(PDF/11.69 KB)

Finnish
(PDF/11.46 KB)

French
(PDF/11.59 KB)

German
(PDF/11.74 KB)

Greek
(PDF/32.55 KB)

Hungarian
(PDF/20.01 KB)

Icelandic
(PDF/17.08 KB)

Italian
(PDF/11.68 KB)

Latvian
(PDF/31.21 KB)

Lithuanian
(PDF/25.82 KB)

Maltese
(PDF/30.21 KB)

Norwegian
(PDF/14.39 KB)

Polish
(PDF/28.65 KB)

Portuguese
(PDF/11.73 KB)

Romanian
(PDF/30 KB)

Slovak
(PDF/26.5 KB)

Slovenian
(PDF/19.77 KB)

Spanish
(PDF/11.75 KB)

Swedish
(PDF/11.62 KB)
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Ivozall : EPAR - Product Information (PDF/309.37 KB)

First published: 22/11/2019
Bulgarian
(PDF/408 KB)

Croatian
(PDF/355.25 KB)

Czech
(PDF/365.55 KB)

Danish
(PDF/294.57 KB)

Dutch
(PDF/335.02 KB)

Estonian
(PDF/310.58 KB)

Finnish
(PDF/290.64 KB)

French
(PDF/314.65 KB)

German
(PDF/365.38 KB)

Greek
(PDF/424.05 KB)

Hungarian
(PDF/361.17 KB)

Icelandic
(PDF/510.16 KB)

Italian
(PDF/277.28 KB)

Latvian
(PDF/351.63 KB)

Lithuanian
(PDF/337.43 KB)

Maltese
(PDF/506.51 KB)

Norwegian
(PDF/428.64 KB)

Polish
(PDF/352.85 KB)

Portuguese
(PDF/337.81 KB)

Romanian
(PDF/448.73 KB)

Slovak
(PDF/447.91 KB)

Slovenian
(PDF/364.3 KB)

Spanish
(PDF/342.31 KB)

Swedish
(PDF/354.39 KB)
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Ivozall : EPAR - Medicine overview (PDF/86.84 KB)

First published: 22/11/2019
EMA/519636/2019
Bulgarian
(PDF/109.22 KB)

Croatian
(PDF/103.2 KB)

Czech
(PDF/108.31 KB)

Danish
(PDF/84.76 KB)

Dutch
(PDF/85.35 KB)

Estonian
(PDF/84.28 KB)

Finnish
(PDF/84.76 KB)

French
(PDF/86.08 KB)

German
(PDF/86.35 KB)

Greek
(PDF/115.8 KB)

Hungarian
(PDF/105.1 KB)

Italian
(PDF/85.02 KB)

Latvian
(PDF/112.63 KB)

Lithuanian
(PDF/105.54 KB)

Maltese
(PDF/108.03 KB)

Polish
(PDF/107.82 KB)

Portuguese
(PDF/85.56 KB)

Romanian
(PDF/111.5 KB)

Slovak
(PDF/106.8 KB)

Slovenian
(PDF/101.68 KB)

Spanish
(PDF/85.86 KB)

Swedish
(PDF/85.12 KB)
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Human medicine European public assessment report (EPAR): Silodyx (updated)

silodosin, Prostatic Hyperplasia
Date of authorisation: 29/01/2010, Revision: 13, Authorised, Last updated: 22/11/2019
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P/0290/2019: EMA decision of 16 August 2019 on the granting of a product specific waiver for gallium 68-labelled Prostate-Specific Membrane Antigen-11 (68Ga-PSMA-11) (EMEA-002577-PIP01-19) (PDF/163.35 KB)

Adopted
First published: 22/11/2019
EMA/436742/2019
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P/0289/2019: EMA decision of 16 August 2019 on the granting of a product specific waiver for EGFR-cMET bispecific antibody (EMEA-002573-PIP01-19) (PDF/180.67 KB)

Adopted
First published: 22/11/2019
EMA/444280/2019
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P/0288/2019: EMA decision of 16 August 2019 on the granting of a product specific waiver for anti-neonatal Fc receptor human monoclonal antibody (EMEA-002559-PIP01-19) (PDF/151.81 KB)

Adopted
First published: 22/11/2019
EMA/436685/2019
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Valproate - Article 31 - Assessment report (PDF/343.47 KB)

Adopted
First published: 22/11/2019
EMA/568844/2019
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Inlyta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/171.75 KB) (updated)

First published: 18/07/2013
Last updated: 22/11/2019
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Committee for Advanced Therapies (CAT): 17-19 July 2019 (updated)

European Medicines Agency, Amsterdam, the Netherlands, from 17/07/2019 to 19/07/2019, Last updated: 22/11/2019
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Minutes of the CAT meeting 17-19 July 2019 (PDF/258.11 KB)

Adopted
First published: 22/11/2019
EMA/CAT/633465/2019
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EMA tracking tool: relocation to Amsterdam - Main milestones (PDF/3.94 MB) (updated)

First published: 05/03/2018
Last updated: 22/11/2019
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Product information URLs for member states (XLS/570 KB) (updated)

First published: 27/09/2018
Last updated: 22/11/2019
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Human medicine European public assessment report (EPAR): Trevicta (previously Paliperidone Janssen) (updated)

paliperidone palmitate, Schizophrenia
Date of authorisation: 05/12/2014, Revision: 9, Authorised, Last updated: 22/11/2019
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Human medicine European public assessment report (EPAR): Inlyta (updated)

axitinib, Carcinoma, Renal Cell
Date of authorisation: 03/09/2012, Revision: 12, Authorised, Last updated: 22/11/2019
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Ethanol (updated)

Last updated: 22/11/2019
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Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' (updated)

Last updated: 22/11/2019
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Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 1 (PDF/803.95 KB)

Adopted
First published: 22/11/2019
Legal effective date: 22/11/2019
EMA/CHMP/302620/2017 Rev. 1
Bulgarian
(PDF/839.88 KB)

Croatian
(PDF/817.47 KB)

Czech
(PDF/820.69 KB)

Danish
(PDF/775.32 KB)

Dutch
(PDF/774.1 KB)

Estonian
(PDF/748.01 KB)

Finnish
(PDF/768.01 KB)

French
(PDF/796.79 KB)

German
(PDF/777.2 KB)

Greek
(PDF/851.84 KB)

Hungarian
(PDF/830.38 KB)

Icelandic
(PDF/770.42 KB)

Italian
(PDF/767.61 KB)

Latvian
(PDF/825.2 KB)

Lithuanian
(PDF/826.31 KB)

Maltese
(PDF/804.36 KB)

Norwegian
(PDF/769.45 KB)

Polish
(PDF/817.25 KB)

Portuguese
(PDF/765.58 KB)

Romanian
(PDF/821.81 KB)

Slovak
(PDF/818.86 KB)

Slovenian
(PDF/805.68 KB)

Spanish
(PDF/703.08 KB)

Swedish
(PDF/745.16 KB)
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Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Superseded (PDF/274.36 KB) (updated)

Adopted
First published: 09/10/2017
Last updated: 22/11/2019
Legal effective date: 09/10/2017
EMA/CHMP/302620/2017 Corr.1
Bulgarian
(PDF/199.42 KB)

Croatian
(PDF/139.53 KB)

Czech
(PDF/179.71 KB)

Danish
(PDF/166.39 KB)

Dutch
(PDF/177.2 KB)

Estonian
(PDF/158.59 KB)

Finnish
(PDF/165.96 KB)

French
(PDF/175.6 KB)

German
(PDF/175.39 KB)

Greek
(PDF/231.11 KB)

Hungarian
(PDF/182.16 KB)

Icelandic
(PDF/164.88 KB)

Italian
(PDF/165.88 KB)

Latvian
(PDF/190.25 KB)

Lithuanian
(PDF/191.19 KB)

Maltese
(PDF/190.81 KB)

Norwegian
(PDF/166.2 KB)

Polish
(PDF/195.19 KB)

Portuguese
(PDF/169.75 KB)

Romanian
(PDF/173.86 KB)

Slovak
(PDF/182.42 KB)

Slovenian
(PDF/170.48 KB)

Spanish
(PDF/168.06 KB)

Swedish
(PDF/159.03 KB)
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Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use (PDF/680.01 KB)

Adopted
First published: 22/11/2019
EMA/CHMP/43486/2018

57438 results

Regulatory awareness session on medical devices (Webinar)

Ebola (updated)

Human medicine European public assessment report (EPAR): Ivozall

Ivozall : EPAR - Risk-management-plan summary (PDF/93.35 KB)

Ivozall : EPAR - Public assessment report (PDF/399.05 KB)

Ivozall : EPAR - All authorised presentations (PDF/11.59 KB)

Ivozall : EPAR - Product Information (PDF/309.37 KB)

Ivozall : EPAR - Medicine overview (PDF/86.84 KB)

Human medicine European public assessment report (EPAR): Silodyx (updated)

P/0290/2019: EMA decision of 16 August 2019 on the granting of a product specific waiver for gallium 68-labelled Prostate-Specific Membrane Antigen-11 (68Ga-PSMA-11) (EMEA-002577-PIP01-19) (PDF/163.35 KB)

P/0289/2019: EMA decision of 16 August 2019 on the granting of a product specific waiver for EGFR-cMET bispecific antibody (EMEA-002573-PIP01-19) (PDF/180.67 KB)

P/0288/2019: EMA decision of 16 August 2019 on the granting of a product specific waiver for anti-neonatal Fc receptor human monoclonal antibody (EMEA-002559-PIP01-19) (PDF/151.81 KB)

Valproate - Article 31 - Assessment report (PDF/343.47 KB)

Inlyta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/171.75 KB) (updated)

Committee for Advanced Therapies (CAT): 17-19 July 2019 (updated)

Minutes of the CAT meeting 17-19 July 2019 (PDF/258.11 KB)

EMA tracking tool: relocation to Amsterdam - Main milestones (PDF/3.94 MB) (updated)

Product information URLs for member states (XLS/570 KB) (updated)

Human medicine European public assessment report (EPAR): Trevicta (previously Paliperidone Janssen) (updated)

Human medicine European public assessment report (EPAR): Inlyta (updated)

Ethanol (updated)

Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' (updated)

Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 1 (PDF/803.95 KB)

Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Superseded (PDF/274.36 KB) (updated)

Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use (PDF/680.01 KB)