1675 results
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Orphan designation: Ethyl Eicosapentaenoate for: Treatment of Huntington’s disease
Date of designation: 29/12/2000, Positive, Last updated: 04/01/2006see: Ethyl Eicosapent soft gelatin capsules: Withdrawn application … application Ethyl Eicosapent soft gelatin capsules: Orphan designation … Ethyl Eicosapent soft gelatin capsules Ethyl Eicosapent … -
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Withdrawn application: Ethyl Eicosapent soft gelatin capsules
date of withdrawal: 01/12/2009, Initial authorisation, Last updated: 08/12/2009Ethyl Eicosapent soft gelatin capsules: Withdrawn applicati … with thyl Eicosapent soft gelatin capsules? e ethyl eicosapent … was Ethyl Eicosapent soft gelatin capsules expected to oms … -
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Orphan designation: Allogeneic aortic endothelial cells cultured in a porcine gelatin matrix for: Prevention of arteriovenous access failure in haemodialysis patients
Date of designation: 23/02/2011, Withdrawn, Last updated: 11/03/2013cells cultured in a porcine gelatin matrix Overview … cells cultured in a porcine gelatin matrix for the prevention … cells cultured in a porcine gelatin matrix for the prevention … -
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Opinion/decision on a Paediatric investigation plan (PIP): naproxen, esomeprazole magnesium trihydrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000268-PIP01-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 19/09/2008, Last updated: 10/10/2008, Compliance check: XActive substance naproxen esomeprazole magnesium trihydrate … Decision and Opinion PN400NaproxenEsomeprazole EMEA-000268… European … product specific waiver for naproxen, esomeprazole magnesium trihydrate … -
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Opinion/decision on a Paediatric investigation plan (PIP): sumatriptan, naproxen (sodium)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002959-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 10/05/2021, Last updated: 15/02/2022, Compliance check: XActive substance sumatriptan naproxen (sodium) Therapeutic area … waiver for sumatriptan / naproxen (sodium) (EMEA-002959-PIP01-21 … waiver for sumatriptan / naproxen (sodium) (EMEA-002959-PIP01-21 … -
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National expert: Gitte Larsen, Danish Medicines Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 16.98 KB | PDF
Gitte Larsen … Gitte Larsen … Vitae PERSONAL INFORMATION Gitte Larsen WORK EXPERIENCE February … -
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National expert: Gitte Bach-Breitling, Danish Medicines Agency (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 16.37 KB | PDF
Gitte Bach-Breitling … Gitte Bach-Breitling … Vitae PERSONAL INFORMATION Gitte Bach-Breitling WORK EXPERIENCE March … -
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Referral: Gelisia and associated names (updated)
timolol maleate, associated names: Genoptol, Gelisia, Timolol sifi 1 mg/g gel oftalmico, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/12/2022, EC decision date: 27/02/2023, Last updated: 16/03/2023Gelisia and associated names … recommends authorisation of Gelisia (timolol, eye gel) in the EU On 15 December … Agency completed a review of Gelisia following a disagreement … -
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Referral: Diclofenac Sodium Spray Gel 4%
diclofenac sodium, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 18/01/2019, Last updated: 14/02/2019Diclofenac Sodium Spray Gel 4 … of Diclofenac Sodium Spray Gel 4% following a disagreement … is Diclofenac Sodium Spray Gel 4%? Diclofenac Sodium Spray Gel 4% contains the active substance … -
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ICH Q4B Annex 10 Polyacrylamide gel electrophoresis - Scientific guideline
Last updated: 01/12/2009Q4B Annex 10 Polyacrylamide gel electrophoresis - Scientific … Q4B Annex 10 Polyacrylamide gel electrophoresis - Scientific … 10 Step 5 Polyacrylamide gel electrophoresis - general …
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Press release: Eye injuries in people and dogs when using Osurnia ear gel for dogs
CVMP, Last updated: 20/04/2018dogs when using Osurnia ear gel for dogs … Osurnia. Osurnia is an ear gel for the treatment of ear … taken to prevent Osurnia ear gel from contacting the eyes … -
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Human medicine European public assessment report (EPAR): Kentera (previously Oxybutynin Nicobrand)
oxybutynin, Urinary Incontinence, Urge
Date of authorisation: 15/06/2004, Revision: 20, Authorised, Last updated: 11/03/2022across the skin) and as a gel in a sachet or a metering … once within a week. For the gel, the recommended daily dose … corresponds to one gram of gel delivered using a metering … -
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Veterinary medicine European public assessment report (EPAR): Purevax RC
attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), Cats
Date of authorisation: 23/02/2005, Revision: 16, Authorised, Last updated: 29/03/2022 -
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Veterinary medicine European public assessment report (EPAR): Arti-Cell Forte
chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells, Horses
Date of authorisation: 29/03/2019, Revision: 5, Authorised, Last updated: 25/10/2021 -
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Veterinary medicine European public assessment report (EPAR): Kriptazen
halofuginone, Calves, newborn
Date of authorisation: 08/02/2019,
, Revision: 2, Authorised, Last updated: 20/10/2021
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Human medicine European public assessment report (EPAR): Cholib
fenofibrate, simvastatin, Dyslipidemias
Date of authorisation: 26/08/2013, Revision: 13, Authorised, Last updated: 13/08/2021 -
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Veterinary medicine European public assessment report (EPAR): Quadrisol
vedaprofen, Horses
Date of authorisation: 04/12/1997, Revision: 18, Authorised, Last updated: 24/08/2017available as an oral (mouth) gel, is given twice daily before … to one week. The amount of gel given in each dose is adjusted … problems. Quadrisol oral gel improved lameness and soft … -
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Veterinary medicine European public assessment report (EPAR): Doxirobe
doxycycline, Dogs
Date of authorisation: 16/09/1999, Revision: 4, Withdrawn, Last updated: 16/09/2004treatment with the Doxirobe Gel. Use of this product as directed … -
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Veterinary medicine European public assessment report (EPAR): Osurnia
betamethasone acetate, terbinafine, florfenicol, Dogs
Date of authorisation: 31/07/2014, Revision: 11, Authorised, Last updated: 20/07/2021acetate. It is available as a gel to be given into the ear … The contents of one tube of gel are given into each infected … 90 dogs received placebo gel (dummy treatment). The Japanese … -
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Veterinary medicine European public assessment report (EPAR): Ibaflin
ibafloxacin, Dogs; Cats
Date of authorisation: 13/06/2000, Revision: 7, Withdrawn, Last updated: 10/07/2013spp. Ibaflin gel is indicated in dogs for … 300 and 900 mg) and as oral gels (3 and 7.5%). What … either strengths of the oral gel may be used. Cats are treated … -
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Human medicine European public assessment report (EPAR): Filsuvez
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022,
, Revision: 1, Authorised, Last updated: 23/01/2023
Filsuvez is available as a gel that should be applied to … to the wound dressing. The gel should not be applied sparingly … who were using a control gel (a dummy treatment) in combination … -
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Human medicine European public assessment report (EPAR): Ledaga
Chlormethine, Mycosis Fungoides
Date of authorisation: 03/03/2017,, Revision: 8, Authorised, Last updated: 24/01/2022
Ledaga is available as a gel and Caryolysine was available … Ledaga, which is available as a gel, is applied as a thin film … Ledaga is available as a gel and Caryolysine was available … -
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Human medicine European public assessment report (EPAR): EnCyzix
enclomifene citrate, Hypogonadism
Date of refusal: 06/04/2018, Refused, Last updated: 26/01/2018application of a testosterone gel. The main measures of effectiveness … application of a testosterone gel. The main measures of effectiveness … -
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Human medicine European public assessment report (EPAR): NexoBrid
proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012,
, Revision: 14, Authorised, Last updated: 15/02/2023
available as a powder and gel, which are mixed together … mixed together to make a gel (2 g/22 g or 5 g/55 g). What … cm 2 , NexoBrid 2 g/20 g gel is used. For a burn wound … -
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Human medicine European public assessment report (EPAR): Mirvaso
brimonidine tartrate, Skin Diseases
Date of authorisation: 20/02/2014, Revision: 12, Authorised, Last updated: 16/02/2023Mirvaso is available as a gel (3 mg/g) and can only be … the face. Small amounts of gel (about pea size) are applied … Mirvaso with placebo (a dummy gel) over four weeks of treatment …