12427 results
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Human medicine European public assessment report (EPAR): Ziagen (updated)
abacavir, HIV Infections
Date of authorisation: 08/07/1999, Revision: 42, Authorised, Last updated: 24/02/2021abacavir … Human Use (CHMP) Ziagen (abacavir sulfate) Procedure No … The assessment report was drafted before the launch of the … -
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Human medicine European public assessment report (EPAR): Kivexa (updated)
abacavir, lamivudine, HIV Infections
Date of authorisation: 16/12/2004, Revision: 33, Authorised, Last updated: 25/02/2021abacavir / lamivudine … combination containing 600 mg abacavir and 300 mg lamivudine through … the CHMP were: Rapporteur: Dr. E. Abadie Co-Rapporteur … -
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Opinion/decision on a Paediatric investigation plan (PIP): Triumeq, dolutegravir, abacavir, lamivudine (updated)
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 … -
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Human medicine European public assessment report (EPAR): Triumeq (updated)
dolutegravir sodium, lamivudine, abacavir (as sulfate), HIV Infections
Date of authorisation: 31/08/2014, Revision: 20, Authorised, Last updated: 26/02/2021substances : dolutegravir, abacavir and lamivudine. Expand section … of an allergic reaction to abacavir, so they should not take Triumeq … 50 mg dolutegravir / 600 mg abacavir / 300 mg lamivudine), and … -
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Human medicine European public assessment report (EPAR): Trizivir (updated)
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 36, Authorised, Last updated: 25/02/2021abacavir (as sulfate) / lamivudine … tablet contains 300 mg of abacavir (as sulfate), 150 mg lamivudine … replaces the three components (abacavir, lamivudine and zidovudine … -
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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: XActive substance abacavir lamivudine efavirenz Therapeutic … product specific waiver for abacavir / lamivudine / efavirenz … product specific waiver for abacavir / lamivudine / efavirenz … -
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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 and Ethinylestradiol- Drospirenone 24+4 (ethinylestradiol drospirenone, 0.02 mg/3 mg tablets) Outcome … -
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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) Outcome … -
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Referral: Ethinylestradiol-Drospirenone 24+4
ethinylestradiol / 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: 11/01/201324+4 and Ethinylestradiol- Drospirenone 24+4 (ethinylestradiol drospirenone, 0.02 mg/3 mg tablets) Outcome … substances, ethinylestradiol and drospirenone, which are derived from natural … ethinyl estradiol Drospirenone ethinylestradiol drospirenone … -
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Human medicine European public assessment report (EPAR): Multaq (updated)
dronedarone, Atrial Fibrillation
Date of authorisation: 25/11/2009, Revision: 15, Authorised, Last updated: 04/02/2021dronedarone … on the review of Multaq (dronedarone) Outcome of a procedure … contains the active substance dronedarone (400 mg). It was approved … -
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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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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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Referral: Belanette
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 … Robert and Co- Rapporteur was Dr Janos Borvendeg. During their … -
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Orphan designation: Cysteamine hydrochloride for: Treatment of cystinosis
Date of first decision: 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: Combined hormonal contraceptives
desogestrel, gestodene, norgestimate, etonogestrel, drospirenone, dienogest, chlormadinone, nomegestrol, norelgestromin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 16/01/2014, Last updated: 31/01/2014drospirenone, gestodene or desogestrel … Women using a CHC containing drospirenone, gestodene or desogestrel … desogestrel, dienogest, drospirenone, etonogestrel, gestodene … -
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Veterinary medicine European public assessment report (EPAR): Draxxin (updated)
tulathromycin, Pigs, Cattle, Sheep
Date of authorisation: 11/11/2003, Revision: 24, Authorised, Last updated: 01/03/2021Draxxin … Assessment Report (EPAR) for Draxxin. It explains how the Agency … practical information about using Draxxin, animal owners or keepers … -
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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: 25/10/2017Zanil 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 … -
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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 … Dropcys … marketing authorisation for Dropcys (mercaptamine hydrochloride … -
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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 … Dronabinol … product specific waiver for dronabinol (EMEA-000643-PIP01-09) in … -
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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, 23/03/2018Active substance Drospirenone Therapeutic area Endocrinology … 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: XActive substance Drisapersen Therapeutic area Neurology … paediatric investigation plan for drisapersen (EMEA- 30 Churchill … paediatric investigation plan for drisapersen (EMEA- 000746-PIP01-09-M04 … -
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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 first decision: 10/08/2015, Withdrawn, Last updated: 09/07/2019for CD33-directed antibody-drug conjugate consisting of an … pyrrolobenzodiazepine dimer drug for the treatment of acute … CD33-directed antibody-drug conjugate consisting of an …