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 Remove 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European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Withdrawn applications Remove Withdrawn applications filter Paediatric investigation plans Remove Paediatric investigation plans filter Referrals Remove Referrals filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Summaries of opinion (5) Apply Summaries of opinion filter Orphan designations (49) Apply Orphan designations filter

Product number

Patient safety

Yes (6) Apply Yes filter

Authorisation status

Authorised (78) Apply Authorised filter Withdrawn (16) Apply Withdrawn filter

ATC code

Species

Marketing authorisation date

From:

To:

Marketing authorisation holder

Pharmacotherapeutic group

Date of opinion

From:

To:

Withdrawal type

Initial authorisation (2) Apply Initial authorisation filter Post-authorisation (2) Apply Post-authorisation filter

Withdrawal date

From:

To:

PIP decision type

P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) (3) 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 (26) Apply PM: decision 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 (5) 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 (5) Apply Yes filter

Compliance procedure number

Referral name

Referral status

European Commission final decision (3) Apply European Commission final decision filter Opinion provided by Committee for Medicinal Products for Human Use (1) Apply Opinion provided by Committee for Medicinal Products for Human Use filter

Referral safety status

Yes (2) Apply Yes filter

Referral type

Article 20 procedures (3) Apply Article 20 procedures filter Article 31 referrals (1) Apply Article 31 referrals filter

Referral reference number

Referral decision making model

PRAC-CAT-CHMP-EC (1) Apply PRAC-CAT-CHMP-EC filter PRAC-CHMP-EC (1) Apply PRAC-CHMP-EC filter

Referral authorisation model

Centrally and nationally authorised products (mixed) (1) Apply Centrally and nationally authorised products (mixed) filter Centrally authorised product(s) (3) Apply Centrally authorised product(s) filter

Referral PRAC recommendation

Risk minimisation measures (2) Apply Risk minimisation measures filter

Referral procedure start date

From:

To:

Referral PRAC recommendation date

From:

To:

Medicine type

Conditional approval Remove Conditional approval filter Exceptional circumstances Remove Exceptional circumstances filter Accelerated assessment (89) Apply Accelerated assessment filter Additional monitoring (608) Apply Additional monitoring filter Biosimilar (91) Apply Biosimilar filter Generic (335) Apply Generic filter Orphan medicine (285) Apply Orphan medicine filter

Related medicine

Therapeutic area

Last updated

From:

To:

This week This month Last week Last month

First published

From:

To:

156 results

Remove all filtersRemove all filters

Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Withdrawn applications Remove Withdrawn applications filter Referrals Remove Referrals filter Direct healthcare professional communication Remove Direct healthcare professional communication filter Paediatric investigation plans Remove Paediatric investigation plans filter

Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine type Conditional approval Remove Conditional approval filter Exceptional circumstances Remove Exceptional circumstances filter

Sort by

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: 27, Authorised, Last updated: 10/08/2022
List item

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

Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022, , , , Authorised, Last updated: 10/08/2022
List item

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

modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus
Date of authorisation: 31/07/2013, , , Revision: 21, Authorised, Last updated: 09/08/2022
List item

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

ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021, , , , Revision: 22, Authorised, Last updated: 04/08/2022
List item

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

idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007, , , Revision: 24, Authorised, Last updated: 04/08/2022
List item

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

trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021, , , Revision: 6, Authorised, Last updated: 01/08/2022
List item

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

SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021, , , Revision: 3, Authorised, Last updated: 01/08/2022
List item

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

tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021, , , , Revision: 4, Authorised, Last updated: 29/07/2022
List item

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

remdesivir, Coronavirus Infections
Date of authorisation: 03/07/2020, , , Revision: 11, Authorised, Last updated: 28/07/2022
List item

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

Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019, , , Revision: 12, Authorised, Last updated: 28/07/2022
List item

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

adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021, , , , Revision: 22, Authorised, Last updated: 28/07/2022
List item

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

larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019, , , Revision: 6, Authorised, Last updated: 26/07/2022
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: 26, Authorised, Last updated: 22/07/2022
List item

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

onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020, , , , Revision: 6, Authorised, Last updated: 21/07/2022
List item

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

budesonide, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022, , , , Authorised, Last updated: 18/07/2022
List item

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

clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 29/05/2006, , , Revision: 31, Authorised, Last updated: 13/07/2022
List item

Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)

Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020, , , , Revision: 6, Authorised, Last updated: 08/07/2022
List item

Human medicine European public assessment report (EPAR): Zynteglo

Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019, , , , , , Revision: 5, Withdrawn, Last updated: 08/07/2022
List item

Human medicine European public assessment report (EPAR): Paxlovid

(1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido) butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide [PF-07321332], ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022, , Revision: 2, Authorised, Last updated: 06/07/2022
List item

Human medicine European public assessment report (EPAR): Caprelsa

Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012, , , Revision: 22, Authorised, Last updated: 30/06/2022
List item

Human medicine European public assessment report (EPAR): Ocaliva

Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016, , , , Revision: 13, Authorised, Last updated: 30/06/2022
List item

Human medicine European public assessment report (EPAR): Rozlytrek

Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020, , , Revision: 4, Authorised, Last updated: 27/06/2022
List item

Human medicine European public assessment report (EPAR): Lunsumio

mosunetuzumab, Lymphoma, Follicular
Date of authorisation: 03/06/2022, , , , Authorised, Last updated: 23/06/2022
List item

Human medicine European public assessment report (EPAR): Carvykti

ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022, , , , Authorised, Last updated: 17/06/2022
List item

Human medicine European public assessment report (EPAR): Ondexxya

andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019, , , Revision: 12, Authorised, Last updated: 17/06/2022