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P/0393/2019: EMA decision of 4 December 2019 on the granting of a product specific waiver for (3S,7S)-22-(3-(((2-((5-(2-Carboxyethyl)-2-hydroxybenzyl)(carboxymethyl)amino)ethyl)(carboxymethyl)amino)methyl)-4-hydroxyphenyl)-5,13,20-trioxo-4,6,12,19-tetraaz (PDF/224.47 KB) (new)

Adopted
First published: 03/04/2020
EMA/622502/2019
List item

P/0395/2019: EMA decision of 4 December 2019 on the granting of a product specific waiver for a fully humanized immunoglobulin G4 proline, alanine, alanine (IgG4 PAA) based bispecific antibody directed against cluster of differentiation 3 (CD3) receptor c (PDF/211.99 KB) (new)

Adopted
First published: 03/04/2020
EMA/621656/2019
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P/0396/2019: EMA decision of 4 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for atazanavir (sulfate) / ritonavir (EMEA-002588-PIP01-19) (PDF/211.91 KB) (new)

Adopted
First published: 03/04/2020
EMA/623534/2019
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P/0428/2019: EMA decision of 6 December 2019 on the granting of a product specific waiver for duvelisib (EMEA-002587-PIP01-19) (PDF/195.59 KB) (new)

Adopted
First published: 03/04/2020
EMA/633947/2019
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P/0397/2019: EMA decision of 4 December 2019 on the granting of a product specific waiver for diclofenac (sodium) / thiocolchicoside (EMEA-002580-PIP01-19) (PDF/391.58 KB) (new)

Adopted
First published: 03/04/2020
EMA/606270/2019
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P/0422/2019: EMA decision of 6 December 2019 on the agreement of a paediatric investigation plan for phenobarbital (EMEA-002532-PIP01-18) (PDF/262.09 KB) (new)

Adopted
First published: 03/04/2020
EMA/631880/2019
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P/0426/2019: EMA decision of 6 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for synthetic double-stranded siRNA oligonucleotide directed against lactate... (EMEA-002493-PIP01-18) (PDF/280.87 KB) (new)

Adopted
First published: 03/04/2020
EMA/631879/2019
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P/0400/2019: EMA decision of 4 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant human monoclonal antibody against mannan-binding lectinassociated serine pro (PDF/362.13 KB) (new)

Adopted
First published: 03/04/2020
EMA/607137/2019
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Tenofovir disoproxil Mylan-H-C-PSUSA-00002892-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/146.09 KB) (new)

First published: 03/04/2020
EMA/134602/2020
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P/0403/2019: EMA decision of 4 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for marizomib (EMEA-002452-PIP01-18) (PDF/254.25 KB) (new)

Adopted
First published: 03/04/2020
EMA/630196/2019
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P/0423/2019: EMA decision of 5 December 2019 on the agreement of a paediatric investigation plan for artesunate (EMEA-002402-PIP02-18) (PDF/284.42 KB) (new)

Adopted
First published: 03/04/2020
EMA/630062/2019
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P/0420/2019: EMA decision of 4 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for iclaprim (mesylate) (EMEA-002391-PIP02-19) (PDF/257.11 KB) (new)

Adopted
First published: 03/04/2020
EMA/631366/2019
List item

P/0374/2019: EMA decision of 22 November 2019 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent), (EMEA-001501-PIP01-13-M06) (PDF/220.61 KB) (new)

Adopted
First published: 03/04/2020
EMA/557312/2019
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Press release: EMA provides recommendations on compassionate use of remdesivir for COVID-19

CHMP, Last updated: 03/04/2020
List item

Summary on compassionate use for Remdesivir Gilead (PDF/2.33 MB) (new)

Adopted
First published: 03/04/2020
EMA/178637/2020
List item

Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring adressed to member states for Remdesivir Gilead available for compassionate use (PDF/254.44 KB) (new)

Adopted
First published: 03/04/2020
EMA/178636/2020
List item

Nubeqa : EPAR - Public assessment report (PDF/5.3 MB) (new)

Adopted
First published: 03/04/2020
EMA/84124/2020
List item

EMA provides recommendations on compassionate use of remdesivir for COVID-19 (PDF/125.25 KB) (new)

First published: 03/04/2020
EMA/152575/2020
List item

P/0398/2019: EMA decision of 4 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for zanubrutinib (EMEA-002354-PIP02-18) (PDF/417.25 KB) (new)

Adopted
First published: 03/04/2020
EMA/607434/2019
List item

Dexdor-H-C-PSUSA-00000998-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/157.6 KB) (new)

Adopted
First published: 03/04/2020
EMA/689875/2019
List item

P/0407/2019: EMA decision of 4 December 2019 on the agreement of a paediatric investigation plan and on the granting of a waiver for hydrocortisone (hemisuccinate) (EMEA-002305-PIP01-17) (PDF/370.26 KB) (new)

Adopted
First published: 03/04/2020
EMA/607436/2019
List item

Viread-PSUSA-00002892-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/135.16 KB) (new)

First published: 03/04/2020
EMA/134602/2020
List item

P/0380/2019: EMA decision of 4 December 2019 on the granting of a product specific waiver for gefapixant (citrate) (EMEA-002267-PIP02-19) (PDF/357.49 KB) (new)

Adopted
First published: 03/04/2020
EMA/606271/2019
List item

Minutes of the CHMP meeting 27-30 January 2020 (PDF/1.73 MB) (new)

First published: 02/04/2020
EMA/CHMP/114813/2020
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P/0406/2019: EMA decision of 4 December 2019 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for ivosidenib (EMEA-002247-PIP02-17) (PDF/323.61 KB) (new)

Adopted
First published: 02/04/2020
EMA/593200/2019

20920 results

P/0393/2019: EMA decision of 4 December 2019 on the granting of a product specific waiver for (3S,7S)-22-(3-(((2-((5-(2-Carboxyethyl)-2-hydroxybenzyl)(carboxymethyl)amino)ethyl)(carboxymethyl)amino)methyl)-4-hydroxyphenyl)-5,13,20-trioxo-4,6,12,19-tetraaz (PDF/224.47 KB) (new)

P/0395/2019: EMA decision of 4 December 2019 on the granting of a product specific waiver for a fully humanized immunoglobulin G4 proline, alanine, alanine (IgG4 PAA) based bispecific antibody directed against cluster of differentiation 3 (CD3) receptor c (PDF/211.99 KB) (new)

P/0396/2019: EMA decision of 4 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for atazanavir (sulfate) / ritonavir (EMEA-002588-PIP01-19) (PDF/211.91 KB) (new)

P/0428/2019: EMA decision of 6 December 2019 on the granting of a product specific waiver for duvelisib (EMEA-002587-PIP01-19) (PDF/195.59 KB) (new)

P/0397/2019: EMA decision of 4 December 2019 on the granting of a product specific waiver for diclofenac (sodium) / thiocolchicoside (EMEA-002580-PIP01-19) (PDF/391.58 KB) (new)

P/0422/2019: EMA decision of 6 December 2019 on the agreement of a paediatric investigation plan for phenobarbital (EMEA-002532-PIP01-18) (PDF/262.09 KB) (new)

P/0426/2019: EMA decision of 6 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for synthetic double-stranded siRNA oligonucleotide directed against lactate... (EMEA-002493-PIP01-18) (PDF/280.87 KB) (new)

P/0400/2019: EMA decision of 4 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant human monoclonal antibody against mannan-binding lectinassociated serine pro (PDF/362.13 KB) (new)

Tenofovir disoproxil Mylan-H-C-PSUSA-00002892-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/146.09 KB) (new)

P/0403/2019: EMA decision of 4 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for marizomib (EMEA-002452-PIP01-18) (PDF/254.25 KB) (new)

P/0423/2019: EMA decision of 5 December 2019 on the agreement of a paediatric investigation plan for artesunate (EMEA-002402-PIP02-18) (PDF/284.42 KB) (new)

P/0420/2019: EMA decision of 4 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for iclaprim (mesylate) (EMEA-002391-PIP02-19) (PDF/257.11 KB) (new)

P/0374/2019: EMA decision of 22 November 2019 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent), (EMEA-001501-PIP01-13-M06) (PDF/220.61 KB) (new)

Press release: EMA provides recommendations on compassionate use of remdesivir for COVID-19

Summary on compassionate use for Remdesivir Gilead (PDF/2.33 MB) (new)

Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring adressed to member states for Remdesivir Gilead available for compassionate use (PDF/254.44 KB) (new)

Nubeqa : EPAR - Public assessment report (PDF/5.3 MB) (new)

EMA provides recommendations on compassionate use of remdesivir for COVID-19 (PDF/125.25 KB) (new)

P/0398/2019: EMA decision of 4 December 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for zanubrutinib (EMEA-002354-PIP02-18) (PDF/417.25 KB) (new)

Dexdor-H-C-PSUSA-00000998-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/157.6 KB) (new)

P/0407/2019: EMA decision of 4 December 2019 on the agreement of a paediatric investigation plan and on the granting of a waiver for hydrocortisone (hemisuccinate) (EMEA-002305-PIP01-17) (PDF/370.26 KB) (new)

Viread-PSUSA-00002892-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/135.16 KB) (new)

P/0380/2019: EMA decision of 4 December 2019 on the granting of a product specific waiver for gefapixant (citrate) (EMEA-002267-PIP02-19) (PDF/357.49 KB) (new)

Minutes of the CHMP meeting 27-30 January 2020 (PDF/1.73 MB) (new)

P/0406/2019: EMA decision of 4 December 2019 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for ivosidenib (EMEA-002247-PIP02-17) (PDF/323.61 KB) (new)