2188 results
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Human medicine European public assessment report (EPAR): Betaferon
interferon beta-1b, Multiple Sclerosis
Date of authorisation: 30/11/1995, Revision: 33, Authorised, Last updated: 09/12/2020Betaferon Multiple Sclerosis … Authorised interferon beta-1b Overview Betaferon is a medicine used to treat … as the nerves themselves. Betaferon is used in patients: who … -
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Human medicine European public assessment report (EPAR): Extavia (updated)
interferon beta-1b, Multiple Sclerosis
Date of authorisation: 20/05/2008, Revision: 24, Authorised, Last updated: 26/10/2021Authorised interferon beta-1b Overview Extavia is a medicine … active substance interferon beta-1b. This medicine is the same as Betaferon, which is already authorised … EU. The company that makes Betaferon has agreed that its scientific … -
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Human medicine European public assessment report (EPAR): Avonex
interferon beta-1a, Multiple Sclerosis
Date of authorisation: 13/03/1997, Revision: 34, Authorised, Last updated: 12/03/2021Authorised interferon beta-1a Overview Avonex is a medicine … active substance interferon beta-1a. How is Avonex used? Avonex … 30 micrograms of interferon beta‑1a. In adults (aged 18 … -
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Human medicine European public assessment report (EPAR): Plegridy
peginterferon beta-1a, Multiple Sclerosis
Date of authorisation: 17/07/2014, Revision: 21, Authorised, Last updated: 11/03/2021Authorised peginterferon beta-1a Overview Plegridy is a medicine … active substance peginterferon beta-1a. How is Plegridy used? Plegridy … is the protein interferon beta-1a, one of a group of interferons … -
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Human medicine European public assessment report (EPAR): Rebif
interferon beta-1a, Multiple Sclerosis
Date of authorisation: 03/05/1998, Revision: 39, Authorised, Last updated: 07/01/2021Authorised interferon beta-1a Overview Rebif is a medicine … active substance interferon beta-1a. How is Rebif used? Rebif … is the protein interferon beta-1a, one of a group of interferons … -
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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) (updated)
dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,
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, Revision: 10, Authorised, Last updated: 13/10/2021
ziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) Neuroectodermal … Authorised dinutuximab beta Overview This is a summary … active substance dinutuximab beta. How is Qarziba used? Qarziba … -
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Withdrawn application: Biferonex
interferon beta-1a, date of withdrawal: 28/05/2009, Initial authorisation, Last updated: 29/05/2009non-proprietary name (INN): interferon beta-1a On 19 February 2009, the … active substance interferon beta-1a. It was to be available in … in Biferonex, interferon beta-1a, belongs to the group ‘interferons’ … -
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Opinion/decision on a Paediatric investigation plan (PIP): Plegridy, peginterferon beta-1a
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001129-PIP01-11-M04, Route(s) of administration: Subcutaneous use, Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 14/11/2019, Last updated: 27/03/2020, Compliance check: XActive substance peginterferon beta-1a Therapeutic area Neurology … idy Plegridy peginterferon beta-1a peginterferon beta-1a peginterferon beta-1a … -
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Orphan designation: 7-Beta-hydroxy cholesteryl-3-beta-oleate for: Treatment of glioma
Date of designation: 17/12/2010, Positive, Last updated: 19/01/20117-Beta-hydroxy cholesteryl-3 beta-oleate Overview On 17 December 2010 … Chimos SA, France, for 7-beta-hydroxy cholesteryl-3 beta-oleate for the treatment of glioma … PSO 086-10 7-beta-hydroxycholesteryl-3-beta-oleate (Oxysterol … -
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Human medicine European public assessment report (EPAR): Cystadane
Betaine anhydrous, Homocystinuria
Date of authorisation: 14/02/2007, Revision: 14, Authorised, Last updated: 23/09/2021Authorised betaine anhydrous Overview This is … medicine. active substance betaine anhydrous. Because the number … How does Cystadane work? Betaine is a natural substance that … -
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Human medicine European public assessment report (EPAR): NeoRecormon
epoetin beta, Kidney Failure, Chronic; Anemia; Cancer; Blood Transfusion, Autologous
Date of authorisation: 16/07/1997, Revision: 30, Authorised, Last updated: 02/09/2021Authorised epoetin beta Overview This is a summary … active substance epoetin beta. What is NeoRecormon used … substance in NeoRecormon, epoetin beta, is a copy of a human hormone … -
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Human medicine European public assessment report (EPAR): Puregon
follitropin beta, Infertility; Hypogonadism
Date of authorisation: 02/05/1996, Revision: 32, Authorised, Last updated: 16/07/2021follitropin beta … active substance follitropin beta. What is Puregon used for … substance in Puregon, follitropin beta, is a copy of the natural … -
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Human medicine European public assessment report (EPAR): Fabrazyme
agalsidase beta, Fabry Disease
Date of authorisation: 03/08/2001, Revision: 31, Authorised, Last updated: 15/07/2021agalsidase beta … Fabrazyme, INN-agalsidase beta EMA/65766/2013 EMEA/H/C/000370 … Fabrazyme agalsidase beta This is a summary of the … -
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Orphan designation: Beta-artemether, lumefantrine for: Treatment of malaria
Date of designation: 28/01/2010, Positive, Last updated: 25/02/2010Beta-artemetherlumefantrine Overview On 28 January 2010 … International NV, Belgium, for beta-artemether / lumefantrine (powder for … containing a combination of beta-artemether and lumefantrine. This combination … -
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Orphan designation: Chimeric monoclonal antibody against GD2 for: Treatment of neuroblastoma
Date of designation: 08/11/2012, Positive, Last updated: 26/08/2021now known as dinutuximab beta. Chimeric monoclonal antibody … in the EU as Dinutuximab beta EUSA since 8 May 2017. The … ziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) Qarziba (previously … -
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Human medicine European public assessment report (EPAR): Fertavid
follitropin beta, Infertility; Hypogonadism
Date of authorisation: 19/03/2009, Revision: 12, Withdrawn, Last updated: 23/06/2020follitropin beta … Fertavid follitropin beta follitropin beta … -
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Opinion/decision on a Paediatric investigation plan (PIP): 17 beta-estradiol, etonogestrel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001718-PIP01-14, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal delivery system
Decision date: 29/01/2016, Last updated: 29/03/2016, Compliance check: XKey facts 17 beta-estradiol etonogestrel Endocrinology … granting of a waiver for 17 beta-estradiol / etonogestrel (EMEA-001718-PIP01-1 … Generic Related information 17 beta-estradiol / etonogestrel - Notification … -
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Orphan designation: (-)-17(Cyclopropylmethyl)-1,14 beta-dihydroxy-4,5 alpha-epoxy-6beta-[N-methyl-trans-3-(3-furyl) acrylamido] morphinan hydrochloride (nalfurafine) for: Treatment of uraemic pruritus
Date of designation: 11/09/2002, Positive, Last updated: 14/02/201717(Cyclopropylmethyl)-1,14 beta-dihydroxy-4,5 alpha-epoxy-6 beta-[N-methyl-trans-3-(3-furyl) acrylamido] morphinan … 17(Cyclopropylmethyl)-1,14 beta-dihydroxy-4,5 alpha-epoxy-6 … 17(Cyclopropylmethyl)-1,14 beta-dihydroxy-4,5 alpha-epoxy-6 beta-[N-methyl-trans-3-(3-furyl) acrylamido] morphinan … -
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Human medicine European public assessment report (EPAR): Refixia
Nonacog beta pegol, Hemophilia B
Date of authorisation: 02/06/2017,, Revision: 1, Authorised, Last updated: 17/06/2020
Authorised nonacog beta pegol Overview This is a … active substance nonacog beta pegol. How is Refixia used … substance in Refixia, nonacog beta pegol, works in the body … -
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Opinion/decision on a Paediatric investigation plan (PIP): Nomegestrol acetate, 17 beta-estradiol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000250-PIP01-08-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 09/03/2010, Last updated: 28/07/2010, Compliance check: V, 21/05/2010facts Nomegestrol acetate 17 beta-estradiol Endocrinology, -gynacology-fertility-metabolismP/61/2010EMEA-000250-PIP01-08-M02 … Decision nomegestrol acetate, 17 beta -estradiol 000250-PIP01-08-M02 … nomegestrol acetate / 17 beta - estradiol (EMEA-000250-PIP01-08-M02 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Nomegestrol acetate, 17 beta-estradiol
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000658-PIP01-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 13/11/2009, Last updated: 23/12/2009, Compliance check: Xfacts Nomegestrol acetate 17 beta-estradiol Endocrinology, -gynacology-fertility-metabolismP/230/2009EMEA-000658-PIP01-08 … for nomegestrol acetate, 17beta – e... PDF icon application/pdf … for nomegestrol acetate, 17beta – estradiol (EMEA-000658-PIP01-09 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human beta-glucuronidase (rhGUS, UX003)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001540-PIP01-13-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 28/07/2016, Last updated: 21/09/2021, Compliance check: V, 11/12/2019Key facts Recombinant human beta-glucuronidase (rhGUS, UX003) Endocrinology … plan for recombinant human beta-glucuronidase (rhGUS, UX003) (EMEA-001540-PIP01-13-M01 … plan for recombinant human beta-glucuronidase (rhGUS, UX003) (EMEA-001540-PIP01-13-M01 … -
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Orphan designation: Recombinant adeno-associated viral vector serotype 2/1 encoding human beta-hexosaminidase alpha and beta subunits for: Treatment of GM2 gangliosidosis
Date of designation: 17/01/2018, Positive, Last updated: 13/03/2018serotype 2/1 encoding human beta-hexosaminidase alpha and beta subunits Overview On 17 January … serotype 2/1 encoding human beta-hexosaminidase alpha and beta subunits (also known as CAM-GM201 … serotype 2/1 encoding human beta-hexosaminidase alpha and beta subunits for the treatment … -
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Orphan designation: polyethylene glycol-modified human recombinant truncated cystathionine beta-synthase (pegtibatinase) for: Treatment of homocystinuria
Date of designation: 30/05/2016, Positive, Last updated: 16/09/2021recombinant truncated cystathionine beta-synthase (pegtibatinase) Overview … recombinant truncated cystathionine beta-synthase for the treatment of homocystinuria … the time of designation, betaine was authorised in the EU … -
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Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside for: Treatment of anti-MAG neuropathy
Date of designation: 17/07/2017, Positive, Last updated: 18/09/2020polyphenyl(disodium 3-O-sulfo-beta-D- glucopyranuronate)-(13 beta-D-galactopyranoside for the treatment of anti-MAG …