14398 results
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,
, Revision: 4, Authorised, Last updated: 26/04/2023
Ambrisentan Mylan Lung Diseases Respiratory … Authorised ambrisentan Overview Ambrisentan Mylan is a medicine that … the arteries of the lungs. Ambrisentan Mylan is used in patients … -
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Withdrawn application: Ambrisentan Zentiva
ambrisentan, date of withdrawal: 29/04/2019, Initial authorisation, Last updated: 29/05/2019Ambrisentan Zentiva: Withdrawn applicatio … by injection or infusion (drip), do not need to be tested … Ambrisentan Zentiva Ambrisentan Zentiva ambrisentan ambrisentan … -
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Human medicine European public assessment report (EPAR): Volibris (updated)
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/04/2008, Revision: 23, Authorised, Last updated: 24/05/2023Authorised ambrisentan Overview Volibris is a medicine … medicine. active substance ambrisentan. How is Volibris used? Volibris … active substance in Volibris, ambrisentan, blocks the receptors for … -
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Opinion/decision on a Paediatric investigation plan (PIP): Volibris, ambrisentan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000434-PIP01-08-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 08/11/2019, Last updated: 27/03/2020, Compliance check: XVolibris Active substance ambrisentan Therapeutic area Cardiovascular … Volibris Volibris ambrisentan ambrisentan ambrisentan … -
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Orphan designation: ambrisentan for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of designation: 11/04/2005, Withdrawn, Last updated: 18/07/2018Information System AB, Sweden, for ambrisentan for the treatment of pulmonary … Kingdom, in September 2006. Ambrisentan has been authorised in the … the application for orphan drug designation … -
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Orphan designation: ambrisentan for: Treatment idiopathic pulmonary fibrosis
Date of designation: 01/10/2010, Withdrawn, Last updated: 05/09/2011ambrisentan … PSO 029-10 Ambrisentan 7 Westferry Circus … opinion on orphan designation Ambrisentan for the treatment idiopathic … -
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Opinion/decision on a Paediatric investigation plan (PIP): ambrisentan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002030-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/01/2017, Last updated: 19/02/2021, Compliance check: XKey facts ambrisentan Cardiovascular diseasesP/0038/2017EMEA-002030-PIP01-16 … granting of a waiver for ambrisentan / tadalafil (EMEA-0020 … granting of a waiver for ambrisentan / tadalafil (EMEA-002030-PIP01-16 … -
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Human medicine European public assessment report (EPAR): Drovelis
drospirenone, estetrol monohydrate, Contraceptives, Oral
Date of authorisation: 19/05/2021, Revision: 4, Authorised, Last updated: 31/03/2023Drovelis Chemical Actions and Uses Pharmacologic … Actions Physiological Effects of Drugs Reproductive Control Agents Contraceptive … estetroldrospirenone Overview Drovelis is a combined hormonal contraceptive … -
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Human medicine European public assessment report (EPAR): Multaq
dronedarone, Atrial Fibrillation
Date of authorisation: 25/11/2009, Revision: 18, Authorised, Last updated: 25/11/2022dronedarone … on the review of Multaq (dronedarone) Outcome of a procedure … contains the active substance dronedarone (400 mg). It was approved … -
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Human medicine European public assessment report (EPAR): Lydisilka
estetrol monohydrate, drospirenone, Contraceptives, Oral
Date of authorisation: 19/05/2021, Revision: 3, Authorised, Last updated: 31/03/2023Actions Physiological Effects of Drugs Reproductive Control Agents Contraceptive … medicine. active substances drospirenone and estetrol monohydrate … medicine. active substances , drospirenone (a progestogen) and estetrol … -
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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 … -
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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 … -
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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 … -
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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
drotrecogin alfa (activated … Public statement on Xigris (drotrecogin alfa (activated)) Withdrawal … medicinal product Xigris, drotrecogin alfa (activated), which had … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lydisilka, Estetrol, drospirenone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-001332-PIP01-12-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 31/12/2021, Last updated: 28/03/2023, Compliance check: XActive substance Estetrol drospirenone Therapeutic area Endocrinology-Gynaecology-Fertility-Metabolism … investigation plan for estetrol / drospirenone (Lydisilka), (EMEA-001332-PIP01-12-M05 … investigation plan for estetrol / drospirenone (Lydisilka), (EMEA-001332-PIP01-12-M05 … -
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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 … -
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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: 25/10/2017Intervet Ireland Ltd. Magna Drive Magna Business Park Citywest … 24 Ireland Zanil Fluke Drench Oxyclozanide 34 mg/ml Oral … Zanil Suspension Zanil Fluke Drench Zanil Fluke Drench 34 mg/ml Oral Suspension oxy … -
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Veterinary medicine European public assessment report (EPAR): Draxxin
tulathromycin, Pigs; Cattle; Sheep
Date of authorisation: 11/11/2003, Revision: 25, Authorised, Last updated: 24/09/2021Draxxin … Draxxin … marketing authorisation for DRAXXIN (EMEA/V/C/000077/II/0031 … -
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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 … -
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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 … CD33-directed antibody-drug conjugate consisting of an … -
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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 … -
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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 … -
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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 … -
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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 … -
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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-Gynaecology-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, 23/03/2018Active substance drospirenone Therapeutic area Endocrinology-Gynaecology-Fertility-Metabolism … paediatric investigation plan for drospirenone (EMEA- 001495-PIP01-13-M01 … paediatric investigation plan for drospirenone (EMEA- 001495-PIP01-13-M01 …