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242 results

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Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine Referrals Remove Referrals filter European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter

Medicine type Accelerated assessment Remove Accelerated assessment filter Exceptional circumstances Remove Exceptional circumstances filter Biosimilar Remove Biosimilar filter

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Human medicine European public assessment report (EPAR): Kalydeco

ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012, , Revision: 35, Authorised, Last updated: 28/04/2023
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Human medicine European public assessment report (EPAR): Verkazia

ciclosporin, Conjunctivitis; Keratitis
Date of authorisation: 06/07/2018, , , Revision: 7, Authorised, Last updated: 25/04/2023
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Human medicine European public assessment report (EPAR): Epclusa

Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016, , Revision: 20, Authorised, Last updated: 21/04/2023
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Human medicine European public assessment report (EPAR): Inpremzia

insulin human (rDNA), Diabetes Mellitus
Date of authorisation: 25/04/2022, , , Withdrawn, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Pelgraz

pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018, , , Revision: 9, Authorised, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): Ceplene

Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008, , , Revision: 12, Authorised, Last updated: 19/04/2023
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Human medicine European public assessment report (EPAR): Alymsys

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021, , , Revision: 5, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Soliris

Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007, , , Revision: 34, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Hefiya

adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018, , Revision: 12, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Hyrimoz

adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Date of authorisation: 26/07/2018, , Revision: 11, Authorised, Last updated: 17/04/2023
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Human medicine European public assessment report (EPAR): Byooviz

ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Myopia, Degenerative
Date of authorisation: 18/08/2021, , , Revision: 6, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Exviera

dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015, , Revision: 26, Authorised, Last updated: 13/04/2023
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Human medicine European public assessment report (EPAR): Aybintio

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020, , , Revision: 7, Authorised, Last updated: 11/04/2023
List item

Human medicine European public assessment report (EPAR): Onbevzi

bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 11/01/2021, , , Revision: 4, Authorised, Last updated: 11/04/2023
List item

Human medicine European public assessment report (EPAR): Herzuma

trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018, , Revision: 19, Authorised, Last updated: 11/04/2023
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Human medicine European public assessment report (EPAR): Cabometyx

cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016, , Revision: 16, Authorised, Last updated: 05/04/2023
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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)

Dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017, , , , Revision: 14, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Grasustek

pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019, , , Revision: 4, Authorised, Last updated: 31/03/2023
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Human medicine European public assessment report (EPAR): Imvanex

modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013, , , Revision: 25, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Nyvepria

pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020, , , Revision: 5, Authorised, Last updated: 29/03/2023
List item

Human medicine European public assessment report (EPAR): Imraldi

adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017, , Revision: 20, Authorised, Last updated: 24/03/2023
List item

Human medicine European public assessment report (EPAR): Kanjinti

trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 16/05/2018, , Revision: 10, Authorised, Last updated: 24/03/2023
List item

Human medicine European public assessment report (EPAR): Zokinvy

Lonafarnib, Progeria; Laminopathies
Date of authorisation: 18/07/2022, , , , Revision: 1, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Truvelog Mix 30

insulin aspart, Diabetes Mellitus
Date of authorisation: 25/04/2022, , , Revision: 1, Authorised, Last updated: 23/03/2023
List item

Human medicine European public assessment report (EPAR): Terrosa

teriparatide, Osteoporosis
Date of authorisation: 04/01/2017, , , Revision: 6, Authorised, Last updated: 23/03/2023

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242 results

Human medicine European public assessment report (EPAR): Kalydeco

Human medicine European public assessment report (EPAR): Verkazia

Human medicine European public assessment report (EPAR): Epclusa

Human medicine European public assessment report (EPAR): Inpremzia

Human medicine European public assessment report (EPAR): Pelgraz

Human medicine European public assessment report (EPAR): Ceplene

Human medicine European public assessment report (EPAR): Alymsys

Human medicine European public assessment report (EPAR): Soliris

Human medicine European public assessment report (EPAR): Hefiya

Human medicine European public assessment report (EPAR): Hyrimoz

Human medicine European public assessment report (EPAR): Byooviz

Human medicine European public assessment report (EPAR): Exviera

Human medicine European public assessment report (EPAR): Aybintio

Human medicine European public assessment report (EPAR): Onbevzi

Human medicine European public assessment report (EPAR): Herzuma

Human medicine European public assessment report (EPAR): Cabometyx

Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron)

Human medicine European public assessment report (EPAR): Grasustek

Human medicine European public assessment report (EPAR): Imvanex

Human medicine European public assessment report (EPAR): Nyvepria

Human medicine European public assessment report (EPAR): Imraldi

Human medicine European public assessment report (EPAR): Kanjinti

Human medicine European public assessment report (EPAR): Zokinvy

Human medicine European public assessment report (EPAR): Truvelog Mix 30

Human medicine European public assessment report (EPAR): Terrosa