8286 results
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Withdrawn application: Solithromycin Triskel EU Services
date of withdrawal: 27/03/2017, Initial authorisation, Last updated: 02/06/2017Solithromycin Triskel EU Services: Withdrawn … authorisation application for Solithromycin Triskel EU Services solithromycin) On 27 March 2017, Triskel … marketing authorisation for Solithromycin Triskel EU Services, intended … -
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Human medicine European public assessment report (EPAR): Sunosi
solriamfetol hydrochloride, Narcolepsy; Sleep Apnea, Obstructive
Date of authorisation: 16/01/2020,
, Revision: 7, Authorised, Last updated: 14/12/2022
Authorised solriamfetol Overview Sunosi is a medicine … medicine. active substance solriamfetol. How is Sunosi used? Sunosi … active substance in Sunosi, solriamfetol, works is not fully understood … -
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Opinion/decision on a Paediatric investigation plan (PIP): Solifenacin (succinate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000573-PIP01-09-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 29/09/2014, Last updated: 27/07/2015, Compliance check: V, 22/05/2015Key facts Solifenacin (succinate) Uro-nephrologyP/0260/2014EMEA-000573-PIP01-09-M05 … paediatric investigation plan for solifenacin (succinate) (Vesicare and … paediatric investigation plan for solifenacin (succinate) (Vesicare and … -
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Withdrawn application: Solumarv
insulin human, date of withdrawal: 15/11/2012, Initial authorisation, Last updated: 14/12/2012Solumarv: Withdrawn application … authorisation application for Solumarv (human insulin) On 15 … marketing authorisation for Solumarv, intended for the treatment … -
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Referral: Doxyfar 50%
doxycycline hyclate, associated names: Soludox 500 mg/g, Soludox Vet, Soludox 433 mg/g, Doxy Ort 50%, Article 34
Status: European Commission final decision, opinion/position date: 04/05/2011, EC decision date: 13/07/2011, Last updated: 24/08/2011Doxyfar 50%doxycycline hyclate Soludox 500 mg/g Soludox Vet Soludox 433 mg/g Doxy Ort 50% EMA/512470/2011 … Bladel, The Netherlands Soludox 500 mg/g Pulver zum Eingeben … Bladel, The Netherlands Soludox 500 mg/g Pulver zum Eingeben … -
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Orphan designation: Eculizumab for: Treatment of neuromyelitis optica spectrum disorders
Date of designation: 05/08/2013, Positive, Last updated: 20/11/2019been authorised in the EU as Soliris since 26 August 2019. The … Soliris Soliris eculizumab Eculizumab Ecul … the orphan designation of Soliris at the time of marketing … -
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Orphan designation: Eculizumab for: Treatment of atypical haemolytic uraemic syndrome (aHUS)
Date of designation: 24/07/2009, Positive, Last updated: 20/11/2019been authorised in the EU as Soliris since 24 November 2011. The … designation. Update: Eculizumab (Soliris) was authorised in the EU … Update: eculizumab (Soliris) has been authorised in the … -
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Orphan designation: Eculizumab for: Treatment myasthenia gravis
Date of designation: 29/07/2014, Positive, Last updated: 20/11/2019been authorised in the EU as Soliris since 14 August 2017. The … Soliris Soliris eculizumab Eculizumab Ecul … designation EU/3/14/1304 for Soliris (eculizumab) as an orphan … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP05-15-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 11/03/2022, Last updated: 19/04/2023, Compliance check: XInvented name Soliris Active substance Eculizumab … Pharmaceutical form(s) Concentrate for solution for infusion Condition(s … investigation plan for eculizumab (Soliris), (EMEA-000876-PIP05-15-M05 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP03-14-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/12/2020, Last updated: 23/09/2021, Compliance check: XInvented name Soliris Active substance Eculizumab … Pharmaceutical form(s) Concentrate for solution for infusion Condition(s … investigation plan for eculizumab (Soliris), (EMEA-000876-PIP03-14-M05 … -
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Herbal medicinal product: Solani dulcamarae stipites
Solanum dulcamara L., Woody nightshade stem, F: Assessment finalised, Last updated: 21/12/2020Solani dulcamarae stipites Skin … for the stems of the plant Solanum dulcamara L. The plant is … Woody nightshade stem Solanum dulcamara L., stipites This … -
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Herbal medicinal product: Solidaginis virgaureae herba
Solidago virgaurea L., European Goldenrod, F: Assessment finalised, Last updated: 29/11/2020Solidaginis virgaureae herba Urinary … this information. Key facts Solidaginis virgaureae herbaEuropean … the assessment report on Solidago virgaurea L., herba EMA/HMPC/637909/2018Adopted … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP06-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 28/07/2016, Last updated: 20/04/2018, Compliance check: XInvented name Soliris Active substance Eculizumab … Pharmaceutical form(s) Concentrate for solution for infusion Condition(s … graft rejection following solid organ transplantation Route(s … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP02-11-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 21/12/2012, Last updated: 02/03/2018, Compliance check: V, 02/06/2015Invented name Soliris Active substance Eculizumab … Pharmaceutical form(s) Concentrate for solution for infusion Condition(s … investigation plan for eculizumab (Soliris) (EMEA-000876-PIP02-11-M01) 7 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP01-10-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 24/10/2014, Last updated: 02/03/2017, Compliance check: XInvented name Soliris Active substance Eculizumab … Pharmaceutical form(s) Concentrate for solution for infusion Condition(s … investigation plan for eculizumab (Soliris) (EMEA-000876-PIP01-10-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP07-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 01/09/2016, Last updated: 27/10/2016, Compliance check: XInvented name Soliris Active substance Eculizumab … Pharmaceutical form(s) Concentrate for solution for infusion Condition(s … delayed graft function after solid organ transplantation Route(s … -
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Referral: Dectomax injectable solution and its associated names
doramectin, associated names: Dectomax 1% Injektionslösung für Rinder und Schafe, Dectomax Vet, Dectomax 1%, Dectomax 1% Injectable Solution, Prontax, Dectomax solution injectable, Dectomax Injectable Solution for Cattle and Sheep, Article 34
Status: European Commission final decision, opinion/position date: 08/12/2004, EC decision date: 29/03/2005, Last updated: 13/08/2014Dectomax injectable solution and its associated names … Overview Dectomax injectable solution and its associated names … authorisations of Dectomax injectable solution and its associated names … -
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Referral: Ketabel 100 mg/ml solution for injection and associated names
ketamine, associated names: Ketabel vet. 100 mg/ml solution for injection, Belatamin 100 mg/ml solution for injection, Belatamin vet. 100 mg/ml solution for injection, Article 33
Status: European Commission final decision, opinion/position date: 05/12/2019, EC decision date: 04/03/2020, Last updated: 16/04/2020Ketabel 100 mg/ml solution for injection and associated … medicine Ketabel 100 mg/ml solution for injection and associated … veterinary medicine available as solution for injection and contains … -
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Opinion/decision on a Paediatric investigation plan (PIP): 3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6- pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxamide/Sodium chloride solution 4.2% (P-1037 inhalation solution)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002935-PIP01-20, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation solution
Decision date: 02/09/2021, Last updated: 11/01/2023, Compliance check: Xpentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxamide/Sodium chloride solution 4.2% (P-1037 inhalation solution) Pneumology-allergologyP/0377/2021EMEA-002935-PIP01-20 … 3,5-diamino-6- chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)- carbamimidoyl)pyrazine-2-carboxamide/Sodium chloride solution 4.2% (P-1037 inhalation solution) (EMEA-002935-PIP01-20) in … -
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Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,
, 
, Revision: 34, Authorised, Last updated: 18/04/2023
Soliris Cancer Neoplasms Hemic … thorised eculizumab Overview Soliris is a medicine used to treat … clot) and kidney failure. Soliris is used to treat adults with … -
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Human medicine European public assessment report (EPAR): Solymbic
adalimumab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Hidradenitis Suppurativa; Psoriasis; Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,, 
, Revision: 2, Withdrawn, Last updated: 05/03/2019
Solymbic Arthritis, Psoriatic Spondylitis … Solymbic … Solymbic adalimumab adalimumab … -
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Veterinary medicine European public assessment report (EPAR): Solensia
frunevetmab, Cats
Date of authorisation: 17/02/2021, Authorised, Last updated: 25/06/2020Solensia … Solensia … EMA/143616/2021 EMEA/V/C/005179 Solensia (frunevetmab) An overview … -
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Human medicine European public assessment report (EPAR): Solumarv
insulin human, Diabetes Mellitus
Date of refusal: 11/02/2016,, Refused, Last updated: 16/02/2016
Solumarv Diabetes Mellitus … for the medicinal product Solumarv, intended for the treatment … negative opinion. What was Solumarv expected to be used for Solumarv was expected to be used to … -
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Opinion/decision on a Paediatric investigation plan (PIP): Solriamfetol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002184-PIP01-17-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 08/09/2021, Last updated: 13/01/2023, Compliance check: XKey facts Solriamfetol NeurologyP/0394/2021EMEA-002184-PIP01-17-M01 … paediatric investigation plan for solriamfetol (EMEA- 002184-PIP01-17-M01 … paediatric investigation plan for solriamfetol (EMEA- 002184-PIP01-17-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Solithromycin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001581-PIP02-16, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Capsule, hard, Powder for concentrate for solution for infusion, Powder for oral suspension
Decision date: 28/04/2016, Last updated: 20/04/2018, Compliance check: XKey facts Solithromycin Infectious diseasesP/0120/2016EMEA-001581-PIP02-16 … Powder for concentrate for solution for infusion Powder for oral … granting of a waiver for solithromycin (EMEA-001581-PIP02-16) PDF …