For help on how to get the results you want, see our search tips.
117 results
Medicine type
Generic Remove Generic filter
Orphan medicine Remove Orphan medicine filter
Accelerated assessment Remove Accelerated assessment filter
Exceptional circumstances Remove Exceptional circumstances filter
Biosimilar Remove Biosimilar filter
Medicine
Paediatric investigation plans Remove Paediatric investigation plans filter
Summaries of opinion Remove Summaries of opinion filter
Direct healthcare professional communication Remove Direct healthcare professional communication filter
Categories
Human Remove Human filter
-
List item
Summary of opinion: Elzonris
tagraxofusp, opinion date: 23/07/2020, Positive, Last updated: 13/11/2020 -
List item
Summary of opinion: Tecartus
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: Onbevzi
bevacizumab, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
List item
Summary of opinion: Symkevi
tezacaftor, ivacaftor, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
List item
Summary of opinion: Qutavina
teriparatide, opinion date: 25/06/2020, Positive, Last updated: 26/06/2020 -
List item
Summary of opinion: Kyprolis
carfilzomib, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
List item
Summary of opinion: Lenalidomide Krka d.d. Novo mesto
lenalidomide, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
List item
Summary of opinion: Lenalidomide KrKa
lenalidomide, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
List item
Summary of opinion: Sunitinib Accord
sunitinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
List item
Summary of opinion: Lumoxiti
moxetumomab pasudotox, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
List item
Summary of opinion: Kixelle
insulin aspart, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
List item
Summary of opinion: Yuflyma
adalimumab, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
List item
Summary of opinion: Inrebic
fedratinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
List item
Summary of opinion: Lenalidomide Krka d.d.
lenalidomide, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
List item
Summary of opinion: Kalydeco
ivacaftor, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
List item
Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity
Active substance: Fluorouracil, capecitabine, tegafur, DHPC type: Referral - Article 31, Last updated: 04/06/2020 -
List item
Direct healthcare professional communication (DHPC): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter
Active substance: Letermovir, Last updated: 11/09/2020 -
List item
Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion
Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/2020 -
List item
Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)
Active substance: Pirfenidone, DHPC type: Type II variation, Last updated: 29/10/2020 -
List item
Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet
Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020 -
List item
Direct healthcare professional communication (DHPC): Polivy (polatuzumab vedotin)
Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020 -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001659-PIP01-15-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Alprolix, eftrenonacog alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000914-PIP01-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 18/03/2020, Last updated: 03/08/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP03-14-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 21/03/2020, Last updated: 03/08/2020, Compliance check: X