1903 results
Keyword Nutropin Aq Remove keyword
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Withdrawn application: NutropinAq
somatropin, date of withdrawal: 24/01/2008, Post-authorisation, Last updated: 28/01/2008NutropinAq: Withdrawn application … MARKETING AUTHORISATION for NUTROPINAQ International non-proprietary … for the medicinal product NutropinAq 10 mg/2 ml (30 IU) solution … -
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Summary of opinion: Brucellin Aquilon
opinion date: 08/12/2022, Positive, Last updated: 09/12/2022Brucellin Aquilon: Pending EC decision … Brucellin Aquilon … authorisation) Brucellin Aquilon Common name: Brucella abortus … -
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Withdrawn application: Aquilda
date of withdrawal: 23/05/2008, Initial authorisation, Last updated: 28/05/2008Aquilda: Withdrawn application … MARKETING AUTHORISATION for AQUILDA International non-proprietary … marketing authorisation for Aquilda, for the treatment of euvolaemic … -
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Human medicine European public assessment report (EPAR): NutropinAq
somatropin, Turner Syndrome; Dwarfism, Pituitary
Date of authorisation: 15/02/2001, Revision: 19, Authorised, Last updated: 21/04/2022NutropinAq Male Urogenital Diseases Urogenital … part of the EPAR). What is NutropinAq? NutropinAq is a solution for injection … substance somatropin. What is NutropinAq used for NutropinAq is used to treat the following … -
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Veterinary medicine European public assessment report (EPAR): Panacur AquaSol
fenbendazole, Pigs; Chicken
Date of authorisation: 09/12/2011, Revision: 6, Authorised, Last updated: 26/04/2018Panacur AquaSol … report (EPAR) for Panacur AquaSol. It explains how the Agency … advice on how to use Panacur AquaSol. For practical information … -
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Opinion/decision on a Paediatric investigation plan (PIP): Aqueous allergen extract of birch
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-000959-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oral solution
Decision date: 22/12/2010, Last updated: 25/01/2011, Compliance check: XKey facts Aqueous allergen extract of birch … granting of a waiver for Aqueous allergen extract of birch … granting of a waiver for Aqueous allergen extract of birch … -
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Opinion/decision on a Paediatric investigation plan (PIP): Aqueous allergen extract of pollen from Phleum pratense
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-000966-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oral solution
Decision date: 22/12/2010, Last updated: 25/01/2011, Compliance check: XKey facts Aqueous allergen extract of pollen … granting of a waiver for aqueous allergen extract of pollen … granting of a waiver for aqueous allergen extract of pollen … -
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Opinion/decision on a Paediatric investigation plan (PIP): Iron, aqua carbonate hydroxy oxo starch sucrose complex
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000100-PIP01-07-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 03/05/2010, Last updated: 28/07/2010, Compliance check: XKey facts Iron, aqua carbonate hydroxy oxo starch … investigation plan for iron, aqua carbonate hydroxy oxo starch … investigation plan for iron, aqua carbonate hydroxy oxo starch … -
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Opinion/decision on a Paediatric investigation plan (PIP): Aqueous extract of grass pollen from Dactylis glomerata, Festuca pratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa pratensis
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: Aqueous extract of grass pollen from Dactylis glomerata, Festuca pratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa pratensis, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Solution for sublingual use
Decision date: 20/07/2009, Last updated: 16/09/2009, Compliance check: XAqueous extract of grass pollen from … Key facts Aqueous extract of grass pollen from … granting of a waiver for aqueous extract of grass pollen from … -
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National expert: Cheryl Aquilina, Medicines Authority (updated)
- Declaration of interests - 79.88 KB | PDF
- Curriculum Vitae - 21.54 KB | PDF
Cheryl Aquilina … Cheryl Aquilina … Vitae PERSONAL INFORMATION Cheryl Aquilina WORK EXPERIENCE October … -
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Press release: Ipsen Ltd withdraws its application for an extension of indication for NutropinAq
CHMP, Last updated: 28/01/2008extension of indication for NutropinAq … centrally authorised medicine NutropinAq (somatropin NutropinAq was expected to be used for … below the target height. NutropinAq was first authorised in the … -
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National expert: Paula Aquerreta Larraya, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 16.89 KB | PDF
Paula Aquerreta Larraya … Paula Aquerreta Larraya … Vitae PERSONAL INFORMATION Paula Aquerreta Larraya WORK EXPERIENCE February … -
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Environmental risk assessment of veterinary medicinal products intended to be used in aquaculture - Scientific guideline
Last updated: 23/07/2021products intended to be used in aquaculture - Scientific guideline … products intended to be used in aquaculture - Scientific guideline … products intended to be used in aquaculture 6 7 Agreed by ERAWP June …
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VICH GL57 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species - Scientific guideline
Last updated: 03/04/2019product withdrawal periods in aquatic species - Scientific guidelin … product withdrawal periods in aquatic species - Scientific guidelin … product withdrawal periods in aquatic species 7 Draft 8 9 Draft …
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Human medicine European public assessment report (EPAR): Enspryng
satralizumab, Neuromyelitis Optica
Date of authorisation: 24/06/2021,
, Revision: 1, Authorised, Last updated: 15/09/2021
against a protein called aquaporin-4 AQP4). NMOSD is rare, and Enspryng … production of antibodies against AQP4. AQP4 is important for the normal … against a protein called aquaporin-4 AQP4). NMOSD is rare, and Enspryng … -
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Human medicine European public assessment report (EPAR): Uplizna
Inebilizumab, Neuromyelitis Optica
Date of authorisation: 25/04/2022,
, Revision: 1, Authorised, Last updated: 30/11/2022
against a protein called aquaporin-4 AQP4). Uplizna contains the The … produce antibodies that attack AQP4, a protein involved in nerve … that of the patients with AQP4 antibodies, 18 out of 161 … -
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Human medicine European public assessment report (EPAR): Simbrinza
brinzolamide, brimonidine tartrate, Ocular Hypertension; Glaucoma, Open-Angle
Date of authorisation: 18/07/2014, Revision: 10, Authorised, Last updated: 19/12/2022glaucoma (a condition where the aqueous humour, the watery fluid … reducing the production of aqueous humour. Brinzolamide works … for the production of the aqueous humour, while brimonidine … -
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Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,
, , Revision: 33, Authorised, Last updated: 14/11/2022
who have an antibody called AQP4 and whose disease is relapsing … -
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Press release: European Medicines Agency to review the safety of somatropin-containing medicines
Last updated: 10/12/2010somatropin medicines in the EU: NutropinAq, Omnitrope and Valtropin … Generic Related information NutropinAq: EPAR Omnitrope: EPAR Valtropin … somatropin medicines in the EU: NutropinAq, Omnitrope and Valtropin … -
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Press release: Update on somatropin-containing medicines
CHMP, Last updated: 16/12/2010somatropin-containing medicines NutropinAq, Omnitrope and Valtropin are … Generic Related Information NutropinAq: EPAR Omnitrope: EPAR Valtropin … somatropin-containing medicines NutropinAq, Omnitrope and Valtropin … -
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Human medicine European public assessment report (EPAR): Azarga
brinzolamide, timolol maleate, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 25/11/2008, Revision: 16, Authorised, Last updated: 11/10/2022reducing the production of the aqueous humour (the watery fluid … for the production of the aqueous humour. Brinzolamide has … reducing the production of the aqueous humour (the watery fluid … -
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Press release: European Medicines Agency confirms positive benefit-risk balance of somatropin-containing medicines
CHMP, Last updated: 21/12/2011somatropin-containing medicines NutropinAq, Omnitrope and Valtropin … Generic Related information NutropinAq: EPAR Omnitrope: EPAR Valtropin … somatropin-containing medicines NutropinAq, Omnitrope and Valtropin … -
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Orphan designation: Humanised anti-IL-6 receptor monoclonal antibody (satralizumab) for: Treatment of neuromyelitis optica spectrum disorders
Date of designation: 27/06/2016, Positive, Last updated: 30/06/2021Antibodies against the protein AQP4 are found in most patients … optica spectrum disorders. AQP4 plays an important role in … production of antibodies against AQP4. By blocking IL-6, the medicine … -
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Human medicine European public assessment report (EPAR): Azopt
brinzolamide, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 09/03/2000, Revision: 26, Authorised, Last updated: 11/07/2022for the production of the aqueous humour (the watery fluid … slows down the production of aqueous humour, reducing the pressure … for the production of the aqueous humour (the watery fluid … -
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Referral: Altrenogest
altrenogest, Article 35
Status: European Commission final decision, opinion/position date: 19/05/2016, EC decision date: 29/07/2016, Last updated: 08/09/2016hazardous for fish and other aquatic organisms. The CVMP also … literature show a high risk to aquatic organisms arising from other … effects on the reproduction of aquatic organisms, when present in …