Medicines

Fulltext search

For help on how to get the results you want, see our search tips.

Search results

Categories

Human Remove Human filter Veterinary (33) Apply Veterinary filter

Medicine name

Active substance / international non-proprietary name (INN) / common name

Medicine

European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter Orphan designations Remove Orphan designations filter Summaries of opinion (23) Apply Summaries of opinion filter Withdrawn applications (36) Apply Withdrawn applications filter Referrals (17) Apply Referrals filter Direct healthcare professional communication (39) Apply Direct healthcare professional communication filter

Product number

Patient safety

Yes (10) Apply Yes filter

Authorisation status

Authorised (603) Apply Authorised filter Refused (2) Apply Refused filter Withdrawn (112) Apply Withdrawn filter

ATC code

Marketing authorisation date

From:

To:

Marketing authorisation holder

Pharmacotherapeutic group

Date of opinion

From:

To:

PIP decision type

P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) (18) Apply P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter PM: decision on the application for modification of an agreed PIP (175) Apply PM: decision on the application for modification of an agreed PIP filter RPM: decision refers to a refusal on the application for modification of an agreed PIP (2) Apply RPM: decision refers to a refusal on the application for modification of an agreed PIP filter RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) (1) Apply RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter W: decision granting a waiver in all age groups for all conditions or indications (38) Apply W: decision granting a waiver in all age groups for all conditions or indications filter

PIP condition / indication

Pharmaceutical form(s)

Route(s) of administration

Decision date

From:

To:

PIP compliance check

Yes (27) Apply Yes filter

Compliance procedure number

Orphan designation – intended use

Orphan decision number

Orphan designation status

Positive (134) Apply Positive filter Withdrawn (1) Apply Withdrawn filter

Medicine type

Accelerated assessment Remove Accelerated assessment filter Additional monitoring Remove Additional monitoring filter Conditional approval Remove Conditional approval filter Exceptional circumstances Remove Exceptional circumstances filter Generic Remove Generic filter Biosimilar (95) Apply Biosimilar filter Orphan medicine (514) Apply Orphan medicine filter

Related medicine

Therapeutic area

Last updated

From:

To:

This week This month Last week Last month

First published

From:

To:

1086 results

Remove all filtersRemove all filters

Medicine type Additional monitoring Remove Additional monitoring filter Conditional approval Remove Conditional approval filter Exceptional circumstances Remove Exceptional circumstances filter Generic Remove Generic filter Accelerated assessment Remove Accelerated assessment filter

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

Categories Human Remove Human filter

Sort by

List item

Human medicine European public assessment report (EPAR): Dabigatran Etexilate Accord (updated)

Dabigatran etexilate mesilate, Venous Thromboembolism; Arthroplasty, Replacement
Date of authorisation: 26/05/2023, , Authorised, Last updated: 31/05/2023
List item

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

Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 26/05/2023, , , Authorised, Last updated: 31/05/2023
List item

Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)

CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021, , , Revision: 37, Authorised, Last updated: 31/05/2023
List item

Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)

efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017, , Revision: 15, Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan (updated)

sitagliptin hydrochloride monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022, , Revision: 2, Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva (updated)

emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016, , Revision: 7, Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Rivaroxaban Accord (updated)

rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism
Date of authorisation: 16/11/2020, , Revision: 3, Authorised, Last updated: 30/05/2023
List item

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

andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019, , , Revision: 15, Authorised, Last updated: 30/05/2023
List item

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

filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020, , , Revision: 9, Authorised, Last updated: 30/05/2023
List item

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

onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020, , , , Revision: 11, Authorised, Last updated: 30/05/2023
List item

Human medicine European public assessment report (EPAR): Rivaroxaban Mylan (updated)

rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021, , Revision: 3, Authorised, Last updated: 30/05/2023
List item

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

Cipaglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 20/03/2023, , Authorised, Last updated: 30/05/2023
List item

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

ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021, , , Revision: 3, Authorised, Last updated: 30/05/2023
List item

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

brolucizumab, Wet Macular Degeneration
Date of authorisation: 13/02/2020, , Revision: 8, Authorised, Last updated: 26/05/2023
List item

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

CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022, , Revision: 1, Authorised, Last updated: 25/05/2023
List item

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

Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022, , , , Revision: 1, Authorised, Last updated: 25/05/2023
List item

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

Migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016, , , Revision: 16, Authorised, Last updated: 25/05/2023
List item

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

clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006, , , Revision: 33, Authorised, Last updated: 25/05/2023
List item

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

Avalglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 24/06/2022, , Revision: 2, Authorised, Last updated: 25/05/2023
List item

Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan (updated)

lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016, , Revision: 16, Authorised, Last updated: 25/05/2023
List item

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

lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016, , Revision: 19, Authorised, Last updated: 25/05/2023
List item

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

darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018, , , Revision: 10, Authorised, Last updated: 25/05/2023
List item

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

insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018, , , Revision: 8, Authorised, Last updated: 23/05/2023
List item

Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)

insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021, , , Revision: 2, Authorised, Last updated: 23/05/2023
List item

Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)

A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018, , Revision: 13, Authorised, Last updated: 23/05/2023

Load more

1086 results

Human medicine European public assessment report (EPAR): Dabigatran Etexilate Accord (updated)

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

Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)

Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan (updated)

Human medicine European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan (updated)

Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva (updated)

Human medicine European public assessment report (EPAR): Rivaroxaban Accord (updated)

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

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

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

Human medicine European public assessment report (EPAR): Rivaroxaban Mylan (updated)

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

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

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

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

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

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

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

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

Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan (updated)

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

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

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

Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)

Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)