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 (35) 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 Summaries of opinion Remove Summaries of opinion filter Paediatric investigation plans Remove Paediatric investigation plans filter Withdrawn applications (82) Apply Withdrawn applications filter Orphan designations (259) Apply Orphan designations filter Referrals (9) Apply Referrals filter Direct healthcare professional communication (16) Apply Direct healthcare professional communication filter

Product number

Authorisation status

Authorised (415) Apply Authorised filter Refused (18) Apply Refused filter Withdrawn (75) Apply Withdrawn filter

ATC code

Marketing authorisation date

From:

To:

Marketing authorisation holder

Pharmacotherapeutic group

Date of opinion

From:

To:

Opinion status

Negative (1) Apply Negative filter Positive (19) Apply Positive filter

Application type

Initial authorisation (12) Apply Initial authorisation filter Post-authorisation (8) Apply Post-authorisation filter

PIP decision type

P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) (13) 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 (96) 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 (18) 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 (31) Apply Yes filter

Compliance procedure number

Medicine type

Accelerated assessment Remove Accelerated assessment filter Exceptional circumstances Remove Exceptional circumstances filter Generic Remove Generic filter Orphan medicine Remove Orphan medicine filter Additional monitoring (586) Apply Additional monitoring filter Biosimilar (101) Apply Biosimilar filter Conditional approval (82) Apply Conditional approval filter

Related medicine

Therapeutic area

Last updated

From:

To:

This week This month Last week Last month

First published

From:

To:

659 results

Remove all filtersRemove all filters

Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Paediatric investigation plans Remove Paediatric investigation plans filter Summaries of opinion Remove Summaries of opinion filter

Categories Human Remove Human filter

Medicine type Orphan medicine Remove Orphan medicine filter Generic Remove Generic filter Exceptional circumstances Remove Exceptional circumstances filter Accelerated assessment Remove Accelerated assessment filter

Sort by

List item

Human medicine European public assessment report (EPAR): Fintepla

Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020, , , Revision: 7, Authorised, Last updated: 20/10/2023
List item

Human medicine European public assessment report (EPAR): Imatinib Koanaa

imatinib mesilate, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma; Gastrointestinal Stromal Tumors
Date of authorisation: 22/09/2021, , Withdrawn, Last updated: 19/10/2023
List item

Human medicine European public assessment report (EPAR): Zolgensma

onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020, , , , Revision: 13, Authorised, Last updated: 18/10/2023
List item

Human medicine European public assessment report (EPAR): Myalepta

Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018, , , , Revision: 9, Authorised, Last updated: 18/10/2023
List item

Human medicine European public assessment report (EPAR): Filsuvez

dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022, , Revision: 2, Authorised, Last updated: 17/10/2023
List item

Human medicine European public assessment report (EPAR): Farydak

panobinostat lactate anhydrous, Multiple Myeloma
Date of authorisation: 28/08/2015, , Revision: 13, Authorised, Last updated: 13/10/2023
List item

Human medicine European public assessment report (EPAR): Lacosamide Adroiq

lacosamide, Epilepsy
Date of authorisation: 31/05/2023, , Revision: 2, Authorised, Last updated: 13/10/2023
List item

Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH

pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015, , Revision: 16, Withdrawn, Last updated: 12/10/2023
List item

Human medicine European public assessment report (EPAR): Spinraza

nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017, , , Revision: 14, Authorised, Last updated: 12/10/2023
List item

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

rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism
Date of authorisation: 16/11/2020, , Revision: 5, Authorised, Last updated: 12/10/2023
List item

Human medicine European public assessment report (EPAR): Cometriq

cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014, , Revision: 28, Authorised, Last updated: 12/10/2023
List item

Human medicine European public assessment report (EPAR): Alofisel

darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018, , Revision: 11, Authorised, Last updated: 11/10/2023
List item

Human medicine European public assessment report (EPAR): Cabometyx

cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016, , Revision: 18, Authorised, Last updated: 10/10/2023
List item

Human medicine European public assessment report (EPAR): Reblozyl

Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia
Date of authorisation: 25/06/2020, , , Revision: 5, Authorised, Last updated: 09/10/2023
List item

Human medicine European public assessment report (EPAR): Bortezomib Hospira

bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016, , Revision: 13, Authorised, Last updated: 09/10/2023
List item

Human medicine European public assessment report (EPAR): Kalydeco

ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012, , Revision: 37, Authorised, Last updated: 06/10/2023
List item

Human medicine European public assessment report (EPAR): Azacitidine Mylan

azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020, , Revision: 7, Authorised, Last updated: 05/10/2023
List item

Human medicine European public assessment report (EPAR): Tepkinly

epcoritamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/09/2023, , , , Authorised, Last updated: 05/10/2023
List item

Human medicine European public assessment report (EPAR): Kimmtrak

tebentafusp, Uveal Neoplasms
Date of authorisation: 01/04/2022, , , Revision: 1, Authorised, Last updated: 05/10/2023
List item

Human medicine European public assessment report (EPAR): Foclivia

influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 18/10/2009, , Revision: 13, Authorised, Last updated: 03/10/2023
List item

Human medicine European public assessment report (EPAR): Docetaxel Kabi

docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012, , Revision: 15, Authorised, Last updated: 29/09/2023
List item

Human medicine European public assessment report (EPAR): SomaKit TOC

edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016, , Revision: 15, Authorised, Last updated: 29/09/2023
List item

Human medicine European public assessment report (EPAR): Hepcludex

Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020, , , Revision: 11, Authorised, Last updated: 28/09/2023
List item

Human medicine European public assessment report (EPAR): Imatinib Teva

imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 07/01/2013, , Revision: 19, Authorised, Last updated: 28/09/2023
List item

Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan

Acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 09/01/2020, , Revision: 5, Authorised, Last updated: 27/09/2023