14070 results
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Human medicine European public assessment report (EPAR): Drovelis
drospirenone, estetrol monohydrate, Contraceptives, Oral
Date of authorisation: 19/05/2021, Revision: 2, Authorised, Last updated: 29/04/2022Drovelis 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: 17, Authorised, Last updated: 11/04/2022Authorised dronedarone Overview This is a summary … medicine. active substance dronedarone. How is Multaq used? Multaq … active substance in Multaq, dronedarone, works mainly by blocking … -
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Human medicine European public assessment report (EPAR): Lydisilka
estetrol monohydrate, drospirenone, Contraceptives, Oral
Date of authorisation: 19/05/2021, Revision: 2, Authorised, Last updated: 29/04/2022Actions Physiological Effects of Drugs Reproductive Control Agents Contraceptive … estetrol / drospirenone … EMEA/H/C/005382 Lydisilka (drospirenone / estetrol) An overview … -
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Withdrawn application: Draxxin
tulathromycin, date of withdrawal: 11/05/2012, Post-authorisation, Last updated: 04/07/2012Draxxin: Withdrawn application … variation assessment report DRAXXIN 100 mg/ml Solution for injection … marketing authorisation of DRAXXIN for the treatment and prevention … -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Withdrawn application: Draxxin
tulathromycin, date of withdrawal: 17/01/2007, Post-authorisation, Last updated: 17/01/2007Draxxin: Withdrawn application … AUTHORISATION APPLICATION for DRAXXIN International Non-proprietary … Fusobacterium necrophorum.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Withdrawn application: Multaq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
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 … -
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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 … Assessment Report (EPAR) for Draxxin. It explains how the Agency … practical information about using Draxxin, animal owners or keepers … -
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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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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, -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 … -
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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 … -
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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: 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 … -
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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) Overv … CD33-directed antibody-drug conjugate consisting of an … -
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Orphan designation: Dronabinol, Cannabidiol for: Treatment of glioma
Date of designation: 09/10/2015, Withdrawn, Last updated: 18/11/2015DronabinolCannabidiol Overview … opinion on orphan designation Dronabinol and cannabidiol for the treatment … Ltd, United Kingdom, for dronabinol and cannabidiol for the treatment … -
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Orphan designation: Cannabidiol, Dronabinol for: Treatment of complex regional pain syndrome
Date of designation: 12/11/2021, Positive, Last updated: 08/06/2022Cannabidiol Dronabinol … -
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Referral: Ethinylestradiol-Drospirenone 24+4
ethinyl estradiol, drospirenone, associated names: Yaz 24+4, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 19/04/2012, EC decision date: 06/07/2012, 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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Opinion/decision on a Paediatric investigation plan (PIP): Estetrol, drospirenone
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001332-PIP01-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/12/2020, Last updated: 24/09/2021, Compliance check: XKey facts Estetrol drospirenone Endocrinology, -gynacology-fertility-metabolismP/0478/2020EMEA-001332-PIP01-12-M04 … investigation plan for estetrol / drospirenone (EMEA-001332-PIP01-12-M04 … investigation plan for estetrol / drospirenone (EMEA-001332-PIP01-12-M04 … -
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Referral: Belanette
drospirenone, ethinyl estradiol, 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 … Robert and Co- Rapporteur was Dr Janos Borvendeg. During their … -
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Opinion/decision on a Paediatric investigation plan (PIP): ranolazine, dronedarone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001726-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 05/06/2015, Last updated: 06/07/2015, Compliance check: XKey facts ranolazine dronedarone Cardiovascular diseasesEMEA-001726-PIP01-14EMEA-001726-PIP01-14 … product-specific waiver for ranolazine / dronedarone (EMEA-001726-PIP01-14) PDF … specific waiver for ranolazine / dronedarone (EMEA-001726-PIP01-14) in …