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

Summaries of opinion Remove Summaries of opinion filter Paediatric investigation plans Remove Paediatric investigation plans filter Orphan designations Remove Orphan designations filter Referrals Remove Referrals filter Direct healthcare professional communication Remove Direct healthcare professional communication filter European public assessment reports (EPAR) (480) Apply European public assessment reports (EPAR) filter Withdrawn applications (59) Apply Withdrawn applications filter

Product number

Opinion status

Negative (1) Apply Negative filter Positive (20) Apply Positive filter

Application type

Initial authorisation (10) Apply Initial authorisation filter Post-authorisation (11) Apply Post-authorisation filter

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) (20) 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 (192) 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 (39) 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 (39) Apply Yes filter

Compliance procedure number

Orphan designation – intended use

Orphan decision number

Orphan designation status

Positive (247) Apply Positive filter Withdrawn (9) Apply Withdrawn filter

Referral name

Referral status

European Commission final decision (17) Apply European Commission final decision filter Procedure started (1) Apply Procedure started filter

Referral safety status

Yes (7) Apply Yes filter

Referral type

Article 20 procedures (14) Apply Article 20 procedures filter Article 31 referrals (4) 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 (13) Apply PRAC-CHMP-EC filter

Referral authorisation model

Centrally and nationally authorised products (mixed) (4) Apply Centrally and nationally authorised products (mixed) filter Centrally authorised product(s) (14) Apply Centrally authorised product(s) filter

Referral PRAC recommendation

Risk minimisation measures (11) Apply Risk minimisation measures filter Suspension (2) Apply Suspension filter

Referral procedure start date

From:

To:

Referral PRAC recommendation date

From:

To:

ATC code

Medicine type

Accelerated assessment Remove Accelerated assessment filter Additional monitoring Remove Additional monitoring filter Exceptional circumstances Remove Exceptional circumstances filter Orphan medicine Remove Orphan medicine filter Biosimilar (5) Apply Biosimilar filter Conditional approval (78) Apply Conditional approval filter Generic (10) Apply Generic filter

Related medicine

Therapeutic area

Last updated

From:

To:

This week This month Last week Last month

First published

From:

To:

589 results

Remove all filtersRemove all filters

Categories Human Remove Human filter Veterinary Remove Veterinary filter

Medicine Orphan designations Remove Orphan designations filter Referrals Remove Referrals filter Summaries of opinion Remove Summaries of opinion filter Paediatric investigation plans Remove Paediatric investigation plans filter Direct healthcare professional communication Remove Direct healthcare professional communication filter

Medicine type Exceptional circumstances Remove Exceptional circumstances filter Additional monitoring Remove Additional monitoring filter Accelerated assessment Remove Accelerated assessment filter Orphan medicine Remove Orphan medicine filter

Sort by

List item

Summary of opinion: Albrioza

sodium phenylbutyrate, Ursodoxicoltaurine, opinion date: 22/06/2023, Negative, Last updated: 06/07/2023
List item

Summary of opinion: Inaqovi

cedazuridine, decitabine, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023
List item

Summary of opinion: Bylvay

odevixibat, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023
List item

Summary of opinion: Tepkinly

epcoritamab, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023
List item

Summary of opinion: Tevimbra

tislelizumab, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023
List item

Summary of opinion: Revestive

teduglutide, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023
List item

Summary of opinion: Refixia

nonacog beta pegol, opinion date: 22/06/2023, Positive, Last updated: 23/06/2023
List item

Summary of opinion: Ronapreve

casirivimab, imdevimab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023
List item

Summary of opinion: Jaypirca

pirtobrutinib, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023
List item

Summary of opinion: Camzyos

mavacamten, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023
List item

Summary of opinion: Adcetris (new)

brentuximab vedotin, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023
List item

Summary of opinion: Kaftrio (new)

ivacaftor, tezacaftor, elexacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023
List item

Summary of opinion: Kalydeco (new)

ivacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023
List item

Summary of opinion: Yorvipath (new)

Palopegteriparatide, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023
List item

Summary of opinion: Takhzyro (new)

lanadelumab, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023
List item

Summary of opinion: Finlee (new)

dabrafenib, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023
List item

Summary of opinion: Vanflyta (new)

quizartinib, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023
List item

Summary of opinion: Ryeqo (new)

relugolix, estradiol, norethisterone acetate, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023
List item

Summary of opinion: Voxzogo (new)

vosoritide, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023
List item

Summary of opinion: ZILBRYSQ (new)

Zilucoplan, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023
List item

Summary of opinion: Enhertu (new)

trastuzumab deruxtecan, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023
List item

Direct healthcare professional communication (DHPC): Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) suspension for injection in pre-filled syringe: Important information regarding the potential for breakage of Vaxneuvance pre-filled syringes (updated)

Active substance: Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed), DHPC type: Quality defect, Last updated: 20/09/2023
List item

Referral: Adakveo

crizanlizumab, associated names: Adakveo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/05/2023, EC decision date: 03/08/2023, Last updated: 29/08/2023
List item

Direct healthcare professional communication (DHPC): Potential missing package leaflet in folding boxes of RoActemra (tocilizumab), Hemlibra (emicizumab), Herceptin (trastuzumab), Kadcyla (trastuzumab emtansine), MabThera (rituximab), Phesgo (pertuzumab / trastuzumab) and Tecentriq (atezolizumab)

Active substance: tocilizumab, Emicizumab, trastuzumab, trastuzumab emtansine, rituximab, pertuzumab, trastuzumab, atezolizumab, DHPC type: Quality defect, Last updated: 17/08/2023
List item

Referral: Quinolone- and fluoroquinolone-containing medicinal products

nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin, associated names: Quinsair, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 11/03/2019, Last updated: 08/06/2023

Load more

589 results

Summary of opinion: Albrioza

Summary of opinion: Inaqovi

Summary of opinion: Bylvay

Summary of opinion: Tepkinly

Summary of opinion: Tevimbra

Summary of opinion: Revestive

Summary of opinion: Refixia

Summary of opinion: Ronapreve

Summary of opinion: Jaypirca

Summary of opinion: Camzyos

Summary of opinion: Adcetris (new)

Summary of opinion: Kaftrio (new)

Summary of opinion: Kalydeco (new)

Summary of opinion: Yorvipath (new)

Summary of opinion: Takhzyro (new)

Summary of opinion: Finlee (new)

Summary of opinion: Vanflyta (new)

Summary of opinion: Ryeqo (new)

Summary of opinion: Voxzogo (new)

Summary of opinion: ZILBRYSQ (new)

Summary of opinion: Enhertu (new)

Direct healthcare professional communication (DHPC): Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) suspension for injection in pre-filled syringe: Important information regarding the potential for breakage of Vaxneuvance pre-filled syringes (updated)

Referral: Adakveo

Direct healthcare professional communication (DHPC): Potential missing package leaflet in folding boxes of RoActemra (tocilizumab), Hemlibra (emicizumab), Herceptin (trastuzumab), Kadcyla (trastuzumab emtansine), MabThera (rituximab), Phesgo (pertuzumab / trastuzumab) and Tecentriq (atezolizumab)

Referral: Quinolone- and fluoroquinolone-containing medicinal products