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 (3) 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plans Remove Paediatric investigation plans filter Summaries of opinion (9) Apply Summaries of opinion filter Withdrawn applications (10) Apply Withdrawn applications filter Orphan designations (116) Apply Orphan designations filter Referrals (17) Apply Referrals filter Direct healthcare professional communication (39) Apply Direct healthcare professional communication filter

Product number

Patient safety

Yes (8) Apply Yes filter

Authorisation status

Authorised (335) Apply Authorised filter Refused (1) Apply Refused filter Withdrawn (51) Apply Withdrawn filter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) (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 (149) 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 (26) 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 (19) Apply Yes filter

Compliance procedure number

Medicine type

Additional monitoring Remove Additional monitoring filter Exceptional circumstances Remove Exceptional circumstances filter Accelerated assessment (81) Apply Accelerated assessment filter Biosimilar (96) Apply Biosimilar filter Conditional approval (77) Apply Conditional approval filter Generic (296) Apply Generic filter Orphan medicine (252) Apply Orphan medicine filter

Related medicine

Therapeutic area

Last updated

From:

To:

This week This month Last week Last month

First published

From:

To:

578 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

Categories Human Remove Human filter

Medicine type Exceptional circumstances Remove Exceptional circumstances filter Additional monitoring Remove Additional monitoring filter

Sort by

List item

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

zanubrutinib, Waldenstrom Macroglobulinemia
Date of authorisation: 22/11/2021, , Revision: 7, Authorised, Last updated: 29/09/2023
List item

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

Gefapixant, Cough
Date of authorisation: 15/09/2023, , Authorised, Last updated: 29/09/2023
List item

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

Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020, , , Revision: 6, Withdrawn, Last updated: 29/09/2023
List item

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

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: 40, Authorised, Last updated: 28/09/2023
List item

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

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): Comirnaty (updated)

Single-stranded, 5’-capped messenger RNA 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: 21/12/2020, , , Revision: 44, Authorised, Last updated: 28/09/2023
List item

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

natalizumab, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 22/09/2023, , , Authorised, Last updated: 28/09/2023
List item

Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva (updated)

SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022, , Revision: 6, Authorised, Last updated: 27/09/2023
List item

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

avibactam sodium, ceftazidime pentahydrate, Pneumonia, Bacterial; Soft Tissue Infections; Pneumonia; Urinary Tract Infections; Gram-Negative Bacterial Infections
Date of authorisation: 23/06/2016, , Revision: 15, Authorised, Last updated: 27/09/2023
List item

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

insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021, , , Revision: 3, Authorised, Last updated: 27/09/2023
List item

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

apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019, , Revision: 11, Authorised, Last updated: 27/09/2023
List item

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

ravulizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 02/07/2019, , Revision: 13, Authorised, Last updated: 26/09/2023
List item

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

Respiratory syncytial virus, subgroup A, stabilized prefusion F protein / Respiratory syncytial virus, subgroup B, stabilized prefusion F protein, Respiratory Syncytial Virus Infections
Date of authorisation: 23/08/2023, , , Authorised, Last updated: 26/09/2023
List item

Human medicine European public assessment report (EPAR): Brimica Genuair (updated)

formoterol fumarate dihydrate, aclidinium bromide, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 19/11/2014, , Revision: 14, Authorised, Last updated: 26/09/2023
List item

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

cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012, , , Revision: 13, Authorised, Last updated: 25/09/2023
List item

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

tezepelumab, Asthma
Date of authorisation: 19/09/2022, , Revision: 7, Authorised, Last updated: 22/09/2023
List item

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

amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021, , , Revision: 3, Authorised, Last updated: 22/09/2023
List item

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

brigatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 22/11/2018, , Revision: 9, Authorised, Last updated: 22/09/2023
List item

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

trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021, , , Revision: 12, Authorised, Last updated: 22/09/2023
List item

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

tafamidis, Amyloidosis
Date of authorisation: 16/11/2011, , , , Revision: 27, Authorised, Last updated: 22/09/2023
List item

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

asciminib hydrochloride, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 25/08/2022, , , Revision: 3, Authorised, Last updated: 22/09/2023
List item

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

pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections
Date of authorisation: 13/12/2021, , Revision: 5, Authorised, Last updated: 22/09/2023
List item

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

Tremelimumab, Carcinoma, Hepatocellular
Date of authorisation: 20/02/2023, , Revision: 2, Authorised, Last updated: 22/09/2023
List item

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

Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021, , , Revision: 8, Authorised, Last updated: 22/09/2023
List item

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

larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019, , , Revision: 10, Authorised, Last updated: 22/09/2023