6316 results
Keyword Solu Medrol Remove keyword
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Withdrawn application: Solumarv
insulin human, date of withdrawal: 15/11/2012, Initial authorisation, Last updated: 14/12/2012Solumarv: Withdrawn application … authorisation application for Solumarv (human insulin) On 15 … marketing authorisation for Solumarv, intended for the treatment … -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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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): 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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Orphan designation: Soluble yeast beta-1,3/1,6- glucan for: Prevention of oral mucositis in head and neck cancer patients undergoing radiation therapy
Date of designation: 16/06/2005, Positive, Last updated: 07/04/2011Soluble yeast beta-1,3/1,6- glucan … Pharmacon ASA, Norway, for soluble yeast beta-1,3/1 6- glucan … yet fully understood how soluble yeast beta-1,3/1,6- glucan … -
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Orphan designation: Oxygen, sodium chloride solution 0.9% for: Treatment of amyotrophic lateral sclerosis
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023Oxygen, sodium chloride solution 0.9 … Oxygen, sodium chloride solution 0.9 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soluble yeast beta-1,3/1,6-glucan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Soluble yeast beta-1,3/1,6-glucan, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 03/11/2009, Last updated: 23/12/2009, Compliance check: XSoluble yeast beta-1,3/1,6-glucan Endocrinology … Key facts Soluble yeast beta-1,3/1,6-glucan … beta-1,3/1,6-glucan Cutaneous solution Treatment of diabetic foot … -
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Orphan designation: Soluble recombinant human fibroblast growth factor receptor 3 for: Treatment of achondroplasia (updated)
Date of designation: 27/02/2017, Withdrawn, Last updated: 24/03/2023Soluble recombinant human fibroblast … TherAchon SAS, France, for soluble recombinant human fibroblast … authorisation . Key facts Soluble recombinant human fibroblast … -
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Orphan designation: Recombinant human soluble Fc-gamma receptor II b for: Treatment of idiopathic thrombocytopenic purpura
Date of designation: 02/08/2007, Withdrawn, Last updated: 16/10/2019Recombinant human soluble Fc-gamma receptor II b Overview … Germany, for recombinant human soluble Fc-gamma receptor II b for … designation. Recombinant human soluble Fc-gamma receptor II b could … -
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Referral: Prontax 5 mg/ml pour-on solution for cattle
doramectin, associated names: Dectomax 5 mg/ml pour-on Solution for cattle, Article 33
Status: European Commission final decision, opinion/position date: 08/02/2012, EC decision date: 25/05/2012, Last updated: 05/07/2012Prontax 5 mg/ml pour-on solution for cattle … Overview Prontax 5 mg/ml pour-on solution for cattle (and associated … of Prontax 5 mg/ml pour-on solution for cattle and associated … -
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Referral: Prontax 10 mg/ml solution for injection for cattle, sheep and pigs
doramectin, associated names: Dectomax 10 mg/ml solution for injection for cattle sheep and pigs, Article 33
Status: European Commission final decision, opinion/position date: 08/02/2012, EC decision date: 25/05/2012, Last updated: 05/07/2012Prontax 10 mg/ml solution for injection for cattle … Overview Prontax 10 mg/ml solution for injection for cattle … profile of Prontax 10 mg/ml solution for injection for cattle … -
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Opinion/decision on a Paediatric investigation plan (PIP): Human immunoglobulin (Ig) G4-variant monoclonal antibody that binds and neutralizes soluble human interleukin (IL-) 33
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-002464-PIP01-18, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/08/2019, Last updated: 20/11/2019, Compliance check: Xthat binds and neutralizes soluble human interleukin (IL-) 33 … DermatologyP/0275/2019EMEA-002464-PIP01-18 Solution for injection Treatment of … that binds and neutralizes soluble human interleukin (IL-) 33 … -
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Orphan designation: 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% (w/v) for: Treatment of primary ciliary dyskinesia (updated)
Date of designation: 16/11/2020, Positive, Last updated: 07/03/2023carboxamide, Sodium chloride solution 4.2% (w/v) Overview On 16 … 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% (w/v) (also known as … known as P-1037 Inhalation Solution) for the treatment of primary … -
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Veterinary medicine European public assessment report (EPAR): Locatim (previously Serinucoli)
Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin, Calves, neonatal less than 12 hrs of age
Date of authorisation: 29/03/1999, Revision: 15, Authorised, Last updated: 20/10/2021Authorised Locatim, oral solution for neonatal calves less … prescription. Locatim is an oral solution produced from colostrum (first … and package size: Oral solution >2.8log10 /ml bovine concentrated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soluble human T cell receptor (TCR) directed against the glycoprotein 100 (gp100) melanoma antigen, linked to the single-chain variable fragment (ScFv) domain of the anti-cluster of differentiation 3 (CD3) antibody
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002197-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 01/12/2017, Last updated: 07/03/2018, Compliance check: XKey facts Soluble human T cell receptor (TCR … OncologyEMEA-002197-PIP01-17EMEA-002197-PIP01-17 Concentrate for solution for infusion Treatment of … product specific waiver for soluble human T cell receptor (TCR … -
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Direct healthcare professional communication (DHPC): Briviact® (In Italy: Nubriveo®) (brivaracetam 10Mg/ml) Oral solution: Bottles with narrow neck diameter
Active substance: Brivaracetam, DHPC type: Quality defect, Last updated: 20/12/2021brivaracetam 10Mg/ml) Oral solution: Bottles with narrow neck … brivaracetam 10Mg/ml) Oral solution: Bottles with narrow neck … BRIVARACETAM 10MG/ML) ORAL SOLUTION: BOTTLES WITH NARROW NECK … -
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Press release: Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients
CMDh, Last updated: 29/06/2018Hydroxyethyl starch solutions: CMDh introduces new measures … hydroxyethyl starch (HES) solutions for infusion should remain … with these medicines. HES solutions for infusion are used to … -
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Direct healthcare professional communication (DHPC): Ecalta 100mg powder for concentrate for solution for infusion (anidulafungin) - Solution for infusion must no longer be frozen
Active substance: anidulafungin, DHPC type: Quality defect, Last updated: 14/02/2020powder for concentrate for solution for infusion (anidulafungin … infusion (anidulafungin) - Solution for infusion must no longer … powder for concentrate for solution for infusion (anidulafungin … -
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Referral: Soludox
doxycycline hyclate, Article 13
Status: European Commission final decision, opinion/position date: 12/06/2013, EC decision date: 12/08/2013, Last updated: 24/09/2013Soludox … Commission final decision Overview Soludox 500-mg/g powder for use in … chickens to six days for Soludox 500-mg/g powder for use in … -
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Referral: Ifosfamide solutions
ifosfamide, associated names: Ifosfamide Eg, Ifo-Cell, Ifo-Cell N, Ifo-Cell N 2000, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2021, EC decision date: 21/06/2021, Last updated: 19/07/2021Ifosfamide solutions … Benefits of ifosfamide solutions continue to outweigh risks … Benefits of ifosfamide solutions continue to outweigh risks … -
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Press release: Marvel LifeSciences Ltd withdraws its marketing-authorisation applications for Solumarv, Isomarv medium and Combimarv (human insulin)
Last updated: 27/11/2012marketing-authorisation applications for Solumarv, Isomarv medium and Combimarv … authorisations for the medicines Solumarv, Isomarv medium and Combimarv … international units (IU)/ml solution for injection. They were … -
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Referral: Baxter dialysis solutions
Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/10/2011, EC decision date: 16/12/2011, Last updated: 20/11/2013Baxter dialysis solutions … of endotoxins in dialysis solutions produced at the plant. The … supply of these dialysis solutions in the EU while measures … -
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Referral: Baytril 10% oral solution
enrofloxacin, Article 34
Status: European Commission final decision, opinion/position date: 14/06/2012, EC decision date: 08/10/2012, Last updated: 20/11/2012Baytril 10% oral solution … use only. Baytril 10% oral solution and its associated names … enrofloxacin per millilitre oral solution for use in drinking water …