6974 results
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Referral: Baxter dialysis solutions
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 … dialysis solutions produced at Baxter manufacturing plant Outcome … production processes at Baxter’s manufacturing plant in Castlebar … -
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Orphan designation: Recombinant human bile-salt-stimulated lipase for: Treatment of cystic fibrosis
Date of first decision: 26/01/2005, Withdrawn, Last updated: 10/08/2016Sweden, for recombinant human bile-salt-stimulated lipase for the treatment … inflammation. Recombinant human bile-salt-stimulated lipase might be of potential … of infections. Recombinant bile-salt-stimulated lipase is an enzyme that … -
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Orphan designation: Pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein for: Treatment of glioma
Date of first decision: 30/04/2002, Withdrawn, Last updated: 20/10/2016pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein [hIL13-PE-38QQR … Pseudomonas exotoxin (domains II/III)-Interleukin 13 chimeric protein for the … Pseudomonas exotoxin (domains II/III)-Interleukin 13 chimeric protein for the … -
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Orphan designation: Autologous collagen type II-specific regulatory T cells for: Treatment of non-infectious uveitis
Date of first decision: 16/12/2014, Withdrawn, Last updated: 19/11/2019autologous collagen type II-specific regulatory T cells for the … specifically to collagen type II, a protein present only in … 039;activated' by collagen type II, triggering a cascade of activities … -
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Orphan designation: Adeno-associated viral vector serotype 8 containing the human MTM1 gene (resamirigene bilparvovec) for: Treatment of X-linked myotubular myopathy
Date of first decision: 10/08/2015, Positive, Last updated: 18/09/2020now known as resamirigene bilparvovec. On 10 August 2015, orphan … human MTM1 gene (resamirigene bilparvovec) … -
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Veterinary medicine European public assessment report (EPAR): Baycox Iron
Iron(iii) ion, toltrazuril, Pigs (piglets)
Date of authorisation: 20/05/2019, Authorised, Last updated: 07/04/2020toltrazuril / iron (III) ion … Iron toltrazuril iron (III) ion Iron iii) ion … -
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Veterinary medicine European public assessment report (EPAR): Forceris
toltrazuril, iron (III) ion, Pigs (piglets)
Date of authorisation: 23/04/2019, Authorised, Last updated: 16/05/2019toltrazuril / iron (III) ion … Forceris toltrazuril iron (III) ion iron III) ion … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-000347-PIP02-16-M01, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 04/12/2019, Last updated: 31/03/2020, Compliance check: XInvented name Bilaxten and associated names Active … associated names Active substance Bilastine Therapeutic area Ophthalmology … Bilastine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000347-PIP01-08-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Orodispersible tablet, Oral liquid
Decision date: 04/09/2015, Last updated: 15/06/2015, Compliance check: V, 13/11/2015Invented name Bilaxten and associated names Active … associated names Active substance Bilastine Therapeutic area Pneumology-allergology … paediatric investigation plan for bilastine Bilaxten and associated names), (EMEA-000347-PIP01-08-M06 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Dermatology, Oto-rhino-laryngology, Pneumology-allergology
PIP number: EMEA-000347-PIP05-20, Route(s) of administration: Oral use, Intramuscular use, Intravenous use, Pharmaceutical form(s): Oral solution, Orodispersible tablet, Solution for injection, Tablet
Decision date: 17/06/2020, Last updated: 04/03/2021, Compliance check: XKey facts Bilaxten and associated names Bilastine DermatologyOto-rhino-laryngologyPneumology-allergologyP/0219/2020EMEA-000347-PIP05-20 … product specific waiver for bilastine Bilaxten and associated names), (EMEA … product specific waiver for bilastine Bilaxten and associated names), (EMEA- 000347-PIP05-20 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Dermatology
PIP number: EMEA-000347-PIP03-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Orodispersible film
Decision date: 19/07/2018, Last updated: 22/11/2018, Compliance check: XInvented name Bilaxten and associated names Active … associated names Active substance Bilastine Therapeutic area Dermatology … Bilastine … -
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Orphan designation: Bovine bile extract for: Treatment of pancreatic cancer
Date of first decision: 20/06/2005, Positive, Last updated: 11/04/2016United Kingdom, for bovine bile extract for the treatment … pancreatic cancer. Bovine bile extract might be of potential … preparation isolated from the bile of cattle. The mechanism … -
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Herbal medicinal product: Ginkgo folium
Ginkgo biloba L., Ginkgo leaf, F: Assessment finalised, Last updated: 14/12/2015leaf of the plant Ginkgo biloba L. This summary covers ginkgo … herbal monograph on Ginkgo biloba L., folium 28 January … herbal monograph on Ginkgo biloba L., folium Draft Discussion … -
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Human medicine European public assessment report (EPAR): Giapreza
Angiotensin II acetate, Hypotension, Shock
Date of authorisation: 23/08/2019,
, Authorised, Last updated: 10/10/2019
angiotensin II … Giapreza angiotensin II … -
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 16/10/2009,
, Revision: 6, Authorised, Last updated: 18/01/2019
demic Influenza Vaccine H5N1 Baxter AG Influenza, Human Immunization Disease … Pandemic Influenza Vaccine H5N1 Baxter AG - EMEA/H/C/001200 - T/0026 … product characteristics Annex IIA - Manufacturing-authorisation … -
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Herbal medicinal product: Myrtilli fructus siccus
Vaccinium myrtillus L., Dried Bilberry fruit, F: Assessment finalised, Last updated: 16/12/2015the medicinal uses of dried bilberry fruit. The HMPC conclusions … medicines containing dried bilberry fruit. This summary is not … medicines containing dried bilberry fruit. For practical information … -
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Herbal medicinal product: Myrtilli fructus recens
Vaccinium myrtillus L., Fresh Bilberry fruit, F: Assessment finalised, Last updated: 16/12/2015the medicinal uses of fresh bilberry fruit. The HMPC conclusions … medicines containing fresh bilberry fruit. This summary is not … medicines containing fresh bilberry fruit. For practical information … -
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Orphan designation: HLA class I/II binding tumour associated peptides (ADF-APO-CCN-GUC-K67-MET-MMP-MUC-RGS) for: Treatment of renal-cell carcinoma
Date of first decision: 15/02/2007, Withdrawn, Last updated: 20/10/2016GmbH, Germany, for HLA class I/II binding tumour associated … cell carcinoma. HLA class I/II binding tumour associated … and tumour cells. HLA class I/II binding tumour associated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Angiotensin II (LJPC-501)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001912-PIP02-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 15/04/2019, Last updated: 25/06/2019, Compliance check: XActive substance Angiotensin II (LJPC-501) Therapeutic area … enquiries La Jolla Pharmaceutical II B.V. Tel. +1 6502083191 E-mail … Angiotensin II (LJPC-501 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Angiotensin II (LJPC-501)
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Other
PIP number: EMEA-001912-PIP01-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 26/09/2016, Last updated: 27/10/2016, Compliance check: XActive substance Angiotensin II (LJPC-501) Therapeutic area … deferral for angiotensin II (LJPC-501) (EMEA-001912-PIP01-15) 30 … deferral for angiotensin II (LJPC-501) (EMEA-001912-PIP01-15 … -
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Orphan designation: Recombinant human soluble Fc-gamma receptor II b for: Treatment of idiopathic thrombocytopenic purpura
Date of first decision: 02/08/2007, Withdrawn, Last updated: 16/10/2019soluble Fc-gamma receptor II b for the treatment of idiopathic … soluble Fc-gamma receptor II b could be of potential significant … soluble Fc-gamma receptor II b is designed to bind to … -
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Orphan designation: 18-(p-(131I)-iodophenyl)octadecyl phosphocholine for: Treatment of multiple myeloma
Date of first decision: 17/10/2019, Positive, Last updated: 21/01/2020S.A.R.L., France, for 18-(p-(131I)-iodophenyl)octadecyl phosphocholine (also known … 18-(p-(131I)-iodophenyl)octadecyl phosphocholine … -
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Orphan designation: Bilayer engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts for: Treatment of partial deep dermal and full-thickness burns
Date of first decision: 14/12/2015, Positive, Last updated: 08/06/2017Consulting S.A.R.L., France, for bilayer engineered collagen hydrogel-based … opinion on orphan designation Bilayer engineered collagen hydrogel-based … opinion on orphan designation Bilayer engineered collagen hydrogel-based … -
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Orphan designation: Recombinant human monoclonal antibody against activin receptor type IIB for: Treatment of inclusion body myositis
Date of first decision: 09/08/2012, Withdrawn, Last updated: 24/10/2018against activin receptor type IIB for the treatment of inclusion-body … against activin receptor type IIB' is a monoclonal antibody … called activin receptor type IIB, thereby preventing other … -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human antibody against activin type IIB receptors
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-001286-PIP01-12, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 24/08/2012, Last updated: 18/09/2012, Compliance check: Xantibody against activin type IIB receptors Therapeutic area … antibody against activin type IIB receptors (EMEA-001286-PIP01-12 … antibody against activin type IIB receptors (EMEA-001286-PIP01-12 …