13051 results
-
List item
Human medicine European public assessment report (EPAR): Ziagen
abacavir, HIV Infections
Date of authorisation: 08/07/1999, Revision: 43, Authorised, Last updated: 24/03/2021Authorised abacavir Overview Ziagen is used with … contains the active substance abacavir. How is Ziagen used? Ziagen … Before starting treatment with abacavir, all patients should have … -
List item
Human medicine European public assessment report (EPAR): Kivexa
abacavir, lamivudine, HIV Infections
Date of authorisation: 16/12/2004, Revision: 33, Authorised, Last updated: 25/02/2021Authorised abacavirlamivudine Overview Kivexa is used with … contains two active substances, abacavir and lamivudine. How is Kivexa … tablets, each containing abacavir 600 mg and lamivudine 300 mg … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Triumeq, dolutegravir, abacavir, lamivudine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001219-PIP01-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 03/01/2019, Last updated: 19/02/2021, Compliance check: XActive substance dolutegravir abacavir lamivudine Therapeutic area … Triumeq Triumeq abacavir sulfate / dolutegravir sodium … lamivudine dolutegravir abacavir lamivudine dolutegravir … -
List item
Human medicine European public assessment report (EPAR): Triumeq (updated)
dolutegravir sodium, lamivudine, abacavir (as sulfate), HIV Infections
Date of authorisation: 31/08/2014, Revision: 21, Authorised, Last updated: 09/07/2021Authorised abacavir sulfate / dolutegravir sodium … substances : dolutegravir, abacavir and lamivudine. How is Triumeq … of an allergic reaction to abacavir, so they should not take Triumeq … -
List item
Human medicine European public assessment report (EPAR): Trizivir (updated)
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 38, Authorised, Last updated: 28/07/2021Authorised abacavir (as sulfate) / lamivudine … medicine. active substances (abacavir, lamivudine and zidovudine … medicine. active substances : abacavir, lamivudine and zidovudine … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): abacavir, lamivudine, efavirenz
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002114-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/06/2017, Last updated: 25/07/2017, Compliance check: XKey facts abacavir lamivudine efavirenz Infectious … product-specific waiver for abacavir / lamivudine / efavirenz … product specific waiver for abacavir / lamivudine / efavirenz … -
List item
Human medicine European public assessment report (EPAR): Drovelis
drospirenone, estetrol monohydrate, Contraceptives, Oral
Date of authorisation: 19/05/2021, Authorised, Last updated: 02/06/2021Drovelis Contraceptives, Oral … estetroldrospirenone Overview Drovelis is a combined hormonal contraceptive … contains the active substances drospirenone and estetrol monohydrate … -
List item
Human medicine European public assessment report (EPAR): Multaq
dronedarone, Atrial Fibrillation
Date of authorisation: 25/11/2009, Revision: 15, Authorised, Last updated: 04/02/2021Authorised dronedarone Overview This is a summary … contains the active substance dronedarone. How is Multaq used? Multaq … active substance in Multaq, dronedarone, works mainly by blocking … -
List item
Human medicine European public assessment report (EPAR): Lydisilka
estetrol monohydrate, drospirenone, Contraceptives, Oral
Date of authorisation: 19/05/2021, Authorised, Last updated: 02/06/2021contains the active substances drospirenone and estetrol monohydrate … contains two active substances, drospirenone (a progestogen) and estetrol … present during pregnancy, and drospirenone is a hormone with similar … -
List item
Withdrawn application: Draxxin
tulathromycin, date of withdrawal: 11/05/2012, Post-authorisation, Last updated: 04/07/2012Draxxin: Withdrawn application … variation assessment report DRAXXIN 100 mg/ml Solution for injection … marketing authorisation of DRAXXIN for the treatment and prevention … -
List item
Withdrawn application: Draxxin
tulathromycin, date of withdrawal: 17/01/2007, Post-authorisation, Last updated: 17/01/2007Draxxin: Withdrawn application … AUTHORISATION APPLICATION for DRAXXIN International Non-proprietary … Fusobacterium necrophorum. What is Draxxin? Draxxin is an antibiotic. It is a … -
List item
Withdrawn application: Multaq
dronedarone, date of withdrawal: 06/09/2006, Initial authorisation, Last updated: 08/09/2006Non-proprietary Name (INN): dronedarone This product was later … tablets containing 400 mg of dronedarone. What was MULTAQ expected … active substance in MULTAQ, dronedarone, is an anti-arrhythmic agent … -
List item
Human medicine European public assessment report (EPAR): Xigris
drotrecogin alfa (activated), Sepsis, Multiple Organ Failure
Date of authorisation: 22/08/2002,
, Revision: 13, Withdrawn, Last updated: 21/02/2012
Withdrawn drotrecogin alfa (activated) Overview … details >XigrisEMEA/H/C/000396drotrecogin alfa (activated drotrecogin alfa (activated)SepsisMultiple … information on Xigris Xigris (drotrecogin alfa (activated)) to be withdrawn … -
List item
Orphan designation: Cysteamine hydrochloride for: Treatment of cystinosis
Date of designation: 15/10/2014, Positive, Last updated: 12/11/2014which is formulated as eye drops, can reduce such deposits … which is formulated as eye drops, can reduce such deposits … Dropcys Dropcys mercaptamine Cysteamine … -
List item
Veterinary medicine European public assessment report (EPAR): Draxxin (updated)
tulathromycin, Pigs, Cattle, Sheep
Date of authorisation: 11/11/2003, Revision: 25, Authorised, Last updated: 20/07/2021Draxxin … Assessment Report (EPAR) for Draxxin. It explains how the Agency … practical information about using Draxxin, animal owners or keepers … -
List item
Referral: Zanil and associated names, and generic products thereof
oxyclozanide, associated names: Zanil Suspension, Zanil Fluke Drench, Zanil Fluke Drench 34 mg/ml Oral Suspension, Article 35
Status: European Commission final decision, opinion/position date: 13/07/2017, EC decision date: 28/09/2017, Last updated: 25/10/2017Zanil Suspension Zanil Fluke Drench Zanil Fluke Drench 34 mg/ml Oral Suspension … Intervet Ireland Ltd. Magna Drive Magna Business Park Citywest … 24 Ireland Zanil Fluke Drench Oxyclozanide 34 mg/ml Oral … -
List item
Human medicine European public assessment report (EPAR): Dropcys
mercaptamine, Corneal Diseases, Cystinosis
Date of refusal: 24/06/2016,
, Refused, Last updated: 25/07/2016
Dropcys Corneal Diseases Cystinosis … for the medicinal product Dropcys, intended to prevent and treat … on 1 April 2016. What is Dropcys? Dropcys is a medicine that contains … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dronabinol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: Dronabinol, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 29/10/2010, Last updated: 25/11/2010, Compliance check: XDronabinol Pain … Key facts Dronabinol PainP/214/2010 Dronabinol Oral solution Treatment of … product specific waiver for dronabinol (EMEA-000643-PIP01-09) PDF … -
List item
Referral: Yaz 24+4
ethinylestradiol, drospirenone, associated names: Ethinylestradiol-Drospirenone 24+4, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 19/04/2012, EC decision date: 03/07/2012, Last updated: 11/01/2013substances, ethinylestradiol and drospirenone, which are derived from natural … derived from oestrogen and drospirenone is derived from progesterone … 24+4 (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) PDF … -
List item
Referral: Yvidually
ethinylestradiol, drospirenone, associated names: Flexyess, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/04/2012, EC decision date: 28/09/2012, Last updated: 03/01/2013substances, ethinylestradiol and drospirenone, which are derived from natural … derived from oestrogen and drospirenone is derived from progesterone … names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) PDF … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): drospirenone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001495-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 20/05/2016, Last updated: 27/07/2016, Compliance check: V, 23/03/2018Key facts drospirenone Endocrinology, -gynacology-fertility-metabolismP/0136/2016EMEA-001495-PIP01-13-M01 … paediatric investigation plan for drospirenone (EMEA-001495-PIP01-13-M01 … paediatric investigation plan for drospirenone (EMEA- 001495-PIP01-13-M01 … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Drisapersen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000746-PIP01-09-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 10/06/2015, Last updated: 06/07/2015, Compliance check: XKey facts Drisapersen NeurologyP/0130/2015EMEA-000746-PIP01-09-M04 … paediatric investigation plan for drisapersen (EMEA-000746-PIP01-09-M04 … paediatric investigation plan for drisapersen (EMEA- 30 Churchill … -
List item
Referral: Yasminelle
drospirenone, ethinylestradiol, Article 5(11) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 14/12/2007, EC decision date: 17/06/2008, Last updated: 03/07/2008ethinylestradiol and 3 mg of drospirenone. The MAH submitted variation … 2007. The Rapporteur was Dr Jean-Louis Robert and Co-Rapporteur … Robert and Co-Rapporteur was Dr Janos Borvendeg. During their … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dronabinol (new)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-000643-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 09/09/2020, Last updated: 06/07/2021, Compliance check: XKey facts Dronabinol NeurologyP/0344/2020EMEA-000643-PIP02-20 … product specific waiver for dronabinol (EMEA-000643-PIP02-20) PDF … product specific waiver for dronabinol (EMEA-000643-PIP02-20) in … -
List item
Orphan designation: CD33-directed antibody-drug conjugate consisting of an antibody conjugated to a DNA cross-linking pyrrolobenzodiazepine dimer drug (vadastuximab talirine) for: Treatment of acute myeloid leukaemia
Date of designation: 10/08/2015, Withdrawn, Last updated: 09/07/2019CD33-directed antibody-drug conjugate consisting of an … pyrrolobenzodiazepine dimer drug (vadastuximab talirine) Overv … CD33-directed antibody-drug conjugate consisting of an …