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 (27) 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Orphan designations filter Referrals Remove Referrals filter Summaries of opinion (8) Apply Summaries of opinion filter Withdrawn applications (26) Apply Withdrawn applications filter Direct healthcare professional communication (4) Apply Direct healthcare professional communication filter

Product number

Patient safety

Yes (4) Apply Yes filter

Authorisation status

Authorised (307) Apply Authorised filter Refused (3) Apply Refused filter Withdrawn (57) Apply Withdrawn filter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) (1) 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 (5) 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

PIP condition / indication

Pharmaceutical form(s)

Route(s) of administration

Decision date

From:

To:

Orphan disease / condition

Orphan decision number

Orphan designation status

Positive (20) Apply Positive filter

Referral name

Referral status

European Commission final decision (4) Apply European Commission final decision filter

Referral safety status

Yes (2) Apply Yes filter

Referral type

Article 31 referrals (4) Apply Article 31 referrals filter

Referral reference number

Referral decision making model

PRAC-CHMP-EC (4) Apply PRAC-CHMP-EC filter

Referral authorisation model

Centrally and nationally authorised products (mixed) (4) Apply Centrally and nationally authorised products (mixed) filter

Referral PRAC recommendation

Risk minimisation measures (2) Apply Risk minimisation measures filter Variation (1) Apply Variation filter

Referral procedure start date

From:

To:

Referral PRAC recommendation date

From:

To:

Medicine type

Biosimilar Remove Biosimilar filter Exceptional circumstances Remove Exceptional circumstances filter Generic Remove Generic filter Accelerated assessment (102) Apply Accelerated assessment filter Additional monitoring (643) Apply Additional monitoring filter Conditional approval (83) Apply Conditional approval filter Orphan medicine (426) Apply Orphan medicine filter

Related medicine

Therapeutic area

Last updated

From:

To:

This week This month Last week Last month

First published

From:

To:

398 results

Remove all filtersRemove all filters

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

Categories Human Remove Human filter

Medicine type Exceptional circumstances Remove Exceptional circumstances filter Generic Remove Generic filter Biosimilar Remove Biosimilar filter

Sort by

List item

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

sildenafil, Erectile Dysfunction
Date of authorisation: 21/09/2009, , Revision: 16, Authorised, Last updated: 05/03/2021
List item

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

pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 18/01/2016, , Revision: 6, Authorised, Last updated: 05/03/2021
List item

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

tafamidis, Amyloidosis
Date of authorisation: 16/11/2011, , , , Revision: 18, Authorised, Last updated: 02/03/2021
List item

Human medicine European public assessment report (EPAR): Bortezomib Sun (updated)

bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016, , Revision: 10, Authorised, Last updated: 01/03/2021
List item

Human medicine European public assessment report (EPAR): Daptomycin Hospira (updated)

daptomycin, Soft Tissue Infections, Skin Diseases, Bacterial
Date of authorisation: 22/03/2017, , Revision: 10, Authorised, Last updated: 01/03/2021
List item

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

infliximab, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Crohn Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Psoriasis
Date of authorisation: 26/05/2016, , , Revision: 16, Authorised, Last updated: 01/03/2021
List item

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

trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 08/02/2018, , , Revision: 11, Authorised, Last updated: 01/03/2021
List item

Human medicine European public assessment report (EPAR): Pioglitazone Teva (updated)

pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012, , Revision: 11, Authorised, Last updated: 01/03/2021
List item

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

pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2012, , Revision: 6, Authorised, Last updated: 26/02/2021
List item

Human medicine European public assessment report (EPAR): Lamivudine Teva (updated)

lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009, , Revision: 10, Authorised, Last updated: 26/02/2021
List item

Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)

clopidogrel (as hydrogen sulfate), Acute Coronary Syndrome, Peripheral Vascular Diseases, Myocardial Infarction, Stroke
Date of authorisation: 27/07/2009, , Revision: 16, Authorised, Last updated: 26/02/2021
List item

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

mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008, , Revision: 23, Authorised, Last updated: 26/02/2021
List item

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

entecavir monohydrate, Hepatitis B
Date of authorisation: 18/09/2017, , Revision: 3, Authorised, Last updated: 25/02/2021
List item

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

pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 28/08/2015, , Revision: 9, Authorised, Last updated: 24/02/2021
List item

Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)

levetiracetam, Epilepsy
Date of authorisation: 14/12/2011, , Revision: 14, Authorised, Last updated: 24/02/2021
List item

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

enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016, , , Revision: 17, Authorised, Last updated: 24/02/2021
List item

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

infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid
Date of authorisation: 10/09/2013, , Revision: 22, Authorised, Last updated: 23/02/2021
List item

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

etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis
Date of authorisation: 13/01/2016, , Revision: 13, Authorised, Last updated: 23/02/2021
List item

Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d. (updated)

emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 28/04/2017, , Revision: 7, Authorised, Last updated: 22/02/2021
List item

Human medicine European public assessment report (EPAR): Levetiracetam ratiopharm (updated)

levetiracetam, Epilepsy
Date of authorisation: 26/08/2011, , Revision: 11, Authorised, Last updated: 22/02/2021
List item

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

etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis
Date of authorisation: 20/05/2020, , , Revision: 3, Authorised, Last updated: 22/02/2021
List item

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

trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 16/05/2018, , , Revision: 7, Authorised, Last updated: 22/02/2021
List item

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

efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017, , Revision: 6, Authorised, Last updated: 22/02/2021
List item

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

Palonosetron, Vomiting, Nausea, Cancer
Date of authorisation: 26/05/2016, , Revision: 4, Authorised, Last updated: 18/02/2021
List item

Human medicine European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Apotex) (updated)

clopidogrel (as besilate), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 16/10/2009, , Revision: 20, Authorised, Last updated: 17/02/2021

Load more

398 results

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

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

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

Human medicine European public assessment report (EPAR): Bortezomib Sun (updated)

Human medicine European public assessment report (EPAR): Daptomycin Hospira (updated)

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

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

Human medicine European public assessment report (EPAR): Pioglitazone Teva (updated)

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

Human medicine European public assessment report (EPAR): Lamivudine Teva (updated)

Human medicine European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate) (updated)

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

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

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

Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)

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

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

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

Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d. (updated)

Human medicine European public assessment report (EPAR): Levetiracetam ratiopharm (updated)

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

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

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

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

Human medicine European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Apotex) (updated)