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320 results

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Medicine Maximum residue limits Remove Maximum residue limits filter Withdrawn applications Remove Withdrawn applications filter Summaries of opinion Remove Summaries of opinion filter Orphan designations Remove Orphan designations filter Paediatric investigation plans Remove Paediatric investigation plans filter Direct healthcare professional communication Remove Direct healthcare professional communication filter

Categories Veterinary Remove Veterinary filter Human Remove Human filter

Medicine type Additional monitoring Remove Additional monitoring filter Generic Remove Generic filter

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List item

Summary of opinion: Epclusa

sofosbuvir / velpatasvir, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020
List item

Summary of opinion: Zavicefta

ceftazidime / avibactam, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020
List item

Summary of opinion: Tulinovet

tulathromycin, opinion date: 16/07/2020, Positive, Last updated: 17/07/2020
List item

Summary of opinion: Increxxa

tulathromycin, opinion date: 16/07/2020, Positive, Last updated: 17/07/2020
List item

Summary of opinion: Crysvita

burosumab, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020
List item

Summary of opinion: HyQvia

human normal immunoglobulin, opinion date: 23/07/2020, Positive, Last updated: 24/07/2020
List item

Summary of opinion: Rozlytrek

entrectinib, opinion date: 28/05/2020, Positive, Last updated: 29/05/2020
List item

Summary of opinion: Olumiant

baricitinib, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020
List item

Summary of opinion: Zavicefta

ceftazidime / avibactam, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020
List item

Summary of opinion: Flucelvax Tetra

influenza vaccine surface antigen inactivated prepared in cell cultures, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020
List item

Summary of opinion: Rivaroxaban Accord

rivaroxaban, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020
List item

Summary of opinion: Zejula

niraparib, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020
List item

Summary of opinion: Symkevi

tezacaftor / ivacaftor, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020
List item

Summary of opinion: Deltyba

delamanid, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020
List item

Summary of opinion: Recarbrio

imipenem / cilastatin / relebactam, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020
List item

Summary of opinion: Blincyto

blinatumomab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020
List item

Summary of opinion: Tremfya

guselkumab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020
List item

Summary of opinion: Desloratadine ratiopharm

desloratadine, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020
List item

Summary of opinion: Dupixent

dupilumab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020
List item

Summary of opinion: Lenalidomide Mylan

lenalidomide, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020
List item

Summary of opinion: Tecentriq

atezolizumab, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020
List item

Withdrawn application: Doxorubicin Hydrochloride Tillomed

doxorubicin, date of withdrawal: 02/03/2020, Initial authorisation, Last updated: 27/07/2020
List item

Withdrawn application: Fingolimod Mylan

fingolimod, date of withdrawal: 08/05/2020, Initial authorisation, Last updated: 17/06/2020
List item

Withdrawn application: Keytruda

pembrolizumab, date of withdrawal: 10/12/2019, Post-authorisation, Last updated: 19/03/2020
List item

Withdrawn application: Rotigotine Mylan

rotigotine, date of withdrawal: 22/12/2017, Initial authorisation, Last updated: 11/07/2018

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320 results

Summary of opinion: Epclusa

Summary of opinion: Zavicefta

Summary of opinion: Tulinovet

Summary of opinion: Increxxa

Summary of opinion: Crysvita

Summary of opinion: HyQvia

Summary of opinion: Rozlytrek

Summary of opinion: Olumiant

Summary of opinion: Zavicefta

Summary of opinion: Flucelvax Tetra

Summary of opinion: Rivaroxaban Accord

Summary of opinion: Zejula

Summary of opinion: Symkevi

Summary of opinion: Deltyba

Summary of opinion: Recarbrio

Summary of opinion: Blincyto

Summary of opinion: Tremfya

Summary of opinion: Desloratadine ratiopharm

Summary of opinion: Dupixent

Summary of opinion: Lenalidomide Mylan

Summary of opinion: Tecentriq

Withdrawn application: Doxorubicin Hydrochloride Tillomed

Withdrawn application: Fingolimod Mylan

Withdrawn application: Keytruda

Withdrawn application: Rotigotine Mylan