Insulin Human Winthrop

Główne informacje

  • Nazwa własna:
  • Insulin Human Winthrop
  • Używać do:
  • Ludzie
  • Typ medycyny:
  • alopatycznych narkotyków

Dokumenty

Lokalizacja

  • Dostępne w:
  • Insulin Human Winthrop
    Unia Europejska
  • Język:
  • polski

Informacje terapeutyczne

  • Grupa terapeutyczna:
  • Leki stosowane w cukrzycy,
  • Dziedzina terapeutyczna:
  • Cukrzyca
  • Wskazania:
  • Cukrzyca wymaga leczenia insuliną. Insuliny ludzkiej Winthrop Rapid jest również w leczeniu kwasicy ketonowej i śpiączkę hiperglikemiczną, jak również do osiągnięcia wstępnej, wewnątrz - i pooperacyjnym stabilizacji u pacjentów z cukrzycą.
  • Podsumowanie produktu:
  • Revision: 15

Inne informacje

Status

  • Źródło:
  • EMA - European Medicines Agency
  • Status autoryzacji:
  • Wycofane
  • Numer pozwolenia:
  • EMEA/H/C/000761
  • Data autoryzacji:
  • 17-01-2007
  • Kod EMEA:
  • EMEA/H/C/000761
  • Ostatnia aktualizacja:
  • 08-01-2019

Sprawozdanie z oceny publicznego

European Medicines Agency

7 Westferry Circus, Canary Wharf, London E14 4HB, UK

Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16

E-mail: mail@emea.europa.eu http://www.emea.europa.eu

European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged.

EMEA/H/C/761

EUROPEJSKIE PUBLICZNE SPRAWOZDANIE OCENIAJĄCE (EPAR)

INSULIN HUMAN WINTHROP RAPID

INSULIN HUMAN WINTHROP BASAL

INSULIN HUMAN WINTHROP COMB (15, 25, 30, 50)

INSULIN HUMAN WINTHROP INFUSAT

Streszczenie EPAR dla ogółu społeczeństwa

Niniejszy dokument stanowi streszczenie Europejskiego Publicznego Sprawozdania Oceniającego

(EPAR). Wyjaśnia, jak Komitet ds. Produktów Leczniczych Stosowanych u Ludzi (CHMP) ocenił

przeprowadzone badania w celu ustalenia zaleceń w sprawie stosowania leku.

W celu uzyskania dodatkowych informacji na temat stanu chorobowego lub sposobu leczenia

należy zapoznać się z ulotką dla pacjenta (także stanowiącą część EPAR) bądź skontaktować się z

lekarzem lub farmaceutą. W celu uzyskania dodatkowych informacji na podstawie zaleceń CHMP

należy zapoznać się z dyskusją naukową (także stanowiącą część EPAR).

Co to jest Insulin Human Winthrop?

Insulin Human Winthrop to seria roztworów i zawiesin insuliny do wstrzyknięć. Preparat Insulin

Human Winthrop jest dostarczany w fiolkach, kasetach lub w gotowych do użycia jednorazowych

wstrzykiwaczach (Optiset i SoloStar).

Preparat Insulin Human Winthrop zawiera substancję czynną - insulinę ludzką. Seria preparatów

Insulin Human Winthrop obejmuje roztwory insuliny szybko działającej (Insulin Human Winthrop

Rapie i Insulin Human Winthrop Infusat), które zawierają insulinę rozpuszczalną, zawiesinę insuliny o

pośrednim czasie działania (Insulin Human Winthrop Basal), która zawiera insulinę izofanową oraz

połączenia insuliny o szybkim i o pośrednim czasie działania w różnych proporcjach (Insulin Human

Winthrop Comb):

Insulin Human Winthrop Comb 15: insulina rozpuszczalna 15% i insulina krystaliczna

protaminowa 85%;

Insulin Human Winthrop Comb 25: insulina rozpuszczalna 25% i insulina krystaliczna

protaminowa 75%;

Insulin Human Winthrop Comb 30: insulina rozpuszczalna 30% i insulina krystaliczna

protaminowa 70%;

Insulin Human Winthrop Comb 50: insulina rozpuszczalna 50% i insulina krystaliczna

protaminowa 50%.

Lek ten ma taki sam skład jak Insuman, który jest już dopuszczony do obrotu w Unii Europejskiej

(UE). Firma produkująca preparat Insuman wyraziła zgodę na wykorzystanie swoich danych

naukowych dla preparatu Insulin Human Winthrop.

W jakim celu stosuje się Insulin Human Winthrop?

Preparat Insulin Human Winthrop stosuje się u pacjentów z cukrzycą, którzy wymagają leczenia

insuliną.

Preparat Insulin Human Winthrop Rapid można także stosować w leczeniu śpiączki hiperglikemicznej

(śpiączka spowodowana zbyt wysokim poziomem glukozy [cukru] we krwi) oraz kwasicy ketonowej

(wysoki poziom ketonów [kwasów] we krwi), jak również w celu kontrolowania poziomu glukozy we

krwi przed operacjami, podczas nich oraz po ich zakończeniu.

Produkt leczniczy bez ważnego pozwolenia na dopuszczenie do obrotu

Lek jest dostępny wyłącznie na receptę.

Jak stosować Insulin Human Winthrop?

Preparat Insulin Human Winthrop podaje się we wstrzyknięciach podskórnych wykonywanych

zazwyczaj w brzuch lub udo, zgodnie z zaleceniami lekarza. Za każdym razem należy zmieniać

miejsce wstrzyknięcia. Lekarz określa dla każdego pacjenta indywidualnie wymagany poziom

glukozy we krwi, rodzaj preparatu Insulin Human Winthrop, dawkowanie i harmonogram

dokonywania wstrzyknięć i są one dostosowane do diety, aktywności fizycznej i stylu życia pacjenta.

W celu określenia najniższej skutecznej dawki należy regularnie badać poziom glukozy we krwi

pacjenta. Preparat Insulin Human Winthrop należy podawać przed posiłkami. Dokładny czas

podawania jest określony w ulotce dla pacjenta.

Preparat Insulin Human Winthrop Rapid można także podawać dożylnie, lecz tylko w warunkach

szpitalnych, gdy istnieje możliwość ścisłego monitorowania pacjenta. Preparat Insulin Human

Winthrop Infusat jest specjalnie przygotowany i gotowy do podawania za pomocą pomp infuzyjnych.

Jak działa Insulin Human Winthrop?

Cukrzyca jest chorobą, w której organizm nie wytwarza wystarczającej ilości insuliny do

kontrolowania poziomu glukozy we krwi. Insulin Human Winthrop zawiera insulinę zastępczą, która

jest identyczna, jak insulina wytwarzana przez organizm.

Substancja czynna preparatu Insulin Human Winthrop, insulina ludzka, jest wytwarzana metodą

określaną jako „technologia rekombinacji DNA”: insulina jest wytwarzana przez bakterie, które

otrzymały odpowiedni gen (DNA), umożliwiający im wytwarzanie insuliny. Preparat Insulin Human

Winthrop zawiera insulinę w różnych postaciach: w postaci rozpuszczalnej, która działa szybko (w

ciągu 30 minut od wstrzyknięcia), jak również w postaci izofanowej i krystaliczno-protaminowej,

które są wchłaniane o wiele wolniej w ciągu dnia, co zapewnia dłuższy czas działania.

Insulina zastępcza działa w taki sam sposób, jak naturalnie produkowana insulina naturalna

wytwarzana przez organizm – ułatwia glukozie przechodzenie z krwi do komórek. Dzięki kontroli

poziomu glukozy we krwi można ograniczyć objawy i powikłania cukrzycy.

Jak badano Insulin Human Winthrop?

Preparat Insulin Human Winthrop badano w dwóch badaniach klinicznych z udziałem 611 pacjentów

z cukrzycą typu 1 (w której trzustka nie jest w stanie wytwarzać insuliny) lub typu 2 (w której

organizm nie jest w stanie skutecznie wykorzystywać insuliny). W jednym z tych badań preparat

Insulin Human Winthrop podawano za pomocą pompy infuzyjnej. W drugim badaniu preparat Insulin

Human Winthrop Comb 25 porównywano z półsyntetyczną insuliną ludzką. W badaniach mierzono

poziom glukozy we krwi na czczo (mierzony, gdy pacjent nie przyjmował pokarmu przez co najmniej

osiem godzin) lub poziom substancji we krwi zwanej hemoglobiną glikozylowaną (HbA1c), co

pozwala określić, na ile skutecznie kontrolowany jest poziom glukozy we krwi. W badaniach

obserwowano także liczbę pacjentów, u których wystąpiła hipoglikemia (obniżony poziom glukozy

we krwi)

Jakie korzyści ze stosowania preparatu Insulin Human Winthrop wykazano w badaniach?

Preparat Insulin Human Winthrop spowodował spadek poziomu HbA1c, co wskazuje na podobną

kontrolę poziomu glukozy we krwi, jak w przypadku półsyntetycznej insuliny ludzkiej. Preparat

Insulin Human Winthrop jest skuteczny zarówno w leczeniu cukrzycy typu 1, jak i typu 2.

Jakie ryzyko wiąże się ze stosowaniem preparatu Insulin Human Winthrop?

Preparat Insulin Human Winthrop może powodować hipoglikemię. Pełny wykaz działań

niepożądanych związanych ze stosowaniem preparatu Insulin Human Winthrop znajduje się w ulotce

dla pacjenta.

Preparatu Insulin Human Winthrop nie należy podawać osobom, u których może występować

nadwrażliwość (uczulenie) na insulinę ludzką lub którykolwiek składnik preparatu. Dawki preparatu

Insulin Human Winthrop mogą także wymagać skorygowania w przypadku jego podawania w

połączeniu z innymi lekami, które mogą mieć wpływ na poziom glukozy we krwi. Pełny wykaz tych

leków znajduje się w ulotce dla pacjenta.

Produkt leczniczy bez ważnego pozwolenia na dopuszczenie do obrotu

Na jakiej podstawie zatwierdzono preparat Insulin Human Winthrop?

Komitet ds. Produktów Leczniczych Stosowanych u Ludzi (CHMP) uznał, że korzyści płynące ze

stosowania preparatu Insulin Human Winthrop przewyższają ryzyko w leczeniu cukrzycy. Komitet

zalecił przyznanie pozwolenia na dopuszczenie preparatu Insulin Human Winthrop do obrotu.

Inne informacje dotyczące preparatu Insulin Human Winthrop:

W dniu 17 Stycznia 2007 r. Komisja Europejska przyznała firmie Sanofi-Aventis Deutschland GmbH,

pozwolenie na dopuszczenie preparatu Insulin Human Winthrop do obrotu ważne w całej Unii

Europejskiej.

Pełne sprawozdanie EPAR dotyczące preparatu Insulin Human Winthrop znajduje się tutaj

Data ostatniej aktualizacji: 12-2008.

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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human alpha-galactosidase A (PRX 102), decision type: , therapeutic area: , PIP number: P/0286/2018

Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human alpha-galactosidase A (PRX 102), decision type: , therapeutic area: , PIP number: P/0286/2018

Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human alpha-galactosidase A (PRX 102), decision type: , therapeutic area: , PIP number: P/0286/2018

Europe - EMA - European Medicines Agency

29-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA, decision type: , therapeuti

Opinion/decision on a Paediatric investigation plan (PIP): autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA, decision type: , therapeuti

Opinion/decision on a Paediatric investigation plan (PIP): autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA, decision type: , therapeutic area: , PIP number: P/0290/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription fac

Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription fac

Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription factor (TBX-1400), decision type: , therapeutic area: , PIP number: P/0284/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain, decision t

Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain, decision t

Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain, decision type: , therapeutic area: , PIP number: P/0318/2018

Europe - EMA - European Medicines Agency

28-1-2019


Orphan designation: Pegylated B-domain-deleted sequence-modified recombinant human factor VIII (damoctocog alfa pegol), Treatment of haemophilia A, 23/02/2011, Positive

Orphan designation: Pegylated B-domain-deleted sequence-modified recombinant human factor VIII (damoctocog alfa pegol), Treatment of haemophilia A, 23/02/2011, Positive

Orphan designation: Pegylated B-domain-deleted sequence-modified recombinant human factor VIII (damoctocog alfa pegol), Treatment of haemophilia A, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

28-1-2019


Human medicines European public assessment report (EPAR): Jivi, damoctocog alfa pegol, Hemophilia A, Date of authorisation: 22/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Jivi, damoctocog alfa pegol, Hemophilia A, Date of authorisation: 22/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Jivi, damoctocog alfa pegol, Hemophilia A, Date of authorisation: 22/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

25-1-2019


Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Europe - EMA - European Medicines Agency

23-1-2019


Orphan designation: Humanised anti-IL-6 receptor monoclonal antibody, Treatment of neuromyelitis optica spectrum disorders, 27/06/2016, Positive

Orphan designation: Humanised anti-IL-6 receptor monoclonal antibody, Treatment of neuromyelitis optica spectrum disorders, 27/06/2016, Positive

Orphan designation: Humanised anti-IL-6 receptor monoclonal antibody, Treatment of neuromyelitis optica spectrum disorders, 27/06/2016, Positive

Europe - EMA - European Medicines Agency

23-1-2019

Humalog (Eli Lilly Nederland B.V.)

Humalog (Eli Lilly Nederland B.V.)

Humalog (Active substance: Insulin lispro) - Centralised - Yearly update - Commission Decision (2019)622 of Wed, 23 Jan 2019

Europe -DG Health and Food Safety

23-1-2019


Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/201805

Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/201805

Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/201805

Europe - EMA - European Medicines Agency

22-1-2019

EU/3/14/1422 (BioMarin International Limited)

EU/3/14/1422 (BioMarin International Limited)

EU/3/14/1422 (Active substance: Chimeric fusion protein of recombinant human alpha-N-acetylglucosaminidase and human insulin-like growth factor 2) - Transfer of orphan designation - Commission Decision (2019)575 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003313

Europe -DG Health and Food Safety

22-1-2019


Human medicines European public assessment report (EPAR): Silodosin Recordati, silodosin, Prostatic Hyperplasia, Date of authorisation: 07/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Silodosin Recordati, silodosin, Prostatic Hyperplasia, Date of authorisation: 07/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Silodosin Recordati, silodosin, Prostatic Hyperplasia, Date of authorisation: 07/01/2019, Status: Authorised

Europe - EMA - European Medicines Agency

17-1-2019

Holoclar (Chiesi Farmaceutici S.p.A.)

Holoclar (Chiesi Farmaceutici S.p.A.)

Holoclar (Active substance: Ex vivo expanded autologous human corneal epithelial cells containing stem cells) - Centralised - Annual renewal - Commission Decision (2019)272 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2450/R/21

Europe -DG Health and Food Safety

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human acid ceramidase (RVT-801), decision type: , therapeutic area: , PIP number: P/0319/2018

Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human acid ceramidase (RVT-801), decision type: , therapeutic area: , PIP number: P/0319/2018

Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human acid ceramidase (RVT-801), decision type: , therapeutic area: , PIP number: P/0319/2018

Europe - EMA - European Medicines Agency

15-1-2019

EU/3/18/2126 (Hanmi Europe Limited)

EU/3/18/2126 (Hanmi Europe Limited)

EU/3/18/2126 (Active substance: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment) - Orphan designation - Commission Decision (2019)222 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001592

Europe -DG Health and Food Safety

15-1-2019

Hizentra (CSL Behring GmbH)

Hizentra (CSL Behring GmbH)

Hizentra (Active substance: human normal immunoglobulin) - Centralised - 2-Monthly update - Commission Decision (2019)195 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2127/II/97G

Europe -DG Health and Food Safety

14-1-2019


Human medicines highlights - January 2019

Human medicines highlights - January 2019

Human medicines highlights - January 2019

Europe - EMA - European Medicines Agency

14-1-2019


Applications for new human medicines under evaluation by the CHMP: January 2019

Applications for new human medicines under evaluation by the CHMP: January 2019

Applications for new human medicines under evaluation by the CHMP: January 2019

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of retinitis pigmentosa, 28/07/2015, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of retinitis pigmentosa, 28/07/2015, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of retinitis pigmentosa, 28/07/2015, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Europe - EMA - European Medicines Agency

4-1-2019


Human medicines: highlights of 2018

Human medicines: highlights of 2018

Human medicines: highlights of 2018

Europe - EMA - European Medicines Agency

4-1-2019


Human medicines highlights 2018

Human medicines highlights 2018

Human medicines highlights 2018

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: adeno-associated viral vector serotype hu68 containing the human SMN1 gene, Treatment of spinal muscular atrophy, 24/08/2018, Positive

Orphan designation: adeno-associated viral vector serotype hu68 containing the human SMN1 gene, Treatment of spinal muscular atrophy, 24/08/2018, Positive

Orphan designation: adeno-associated viral vector serotype hu68 containing the human SMN1 gene, Treatment of spinal muscular atrophy, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive

Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive

Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018

EU/3/14/1423 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1423 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1423 (Active substance: Synthetic signal peptide of human mucin-1 (amino acids 1-21)) - Transfer of orphan designation - Commission Decision (2018)9009 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002647

Europe -DG Health and Food Safety

19-12-2018

EU/3/12/1087 (Richardson Associates Regulatory Affairs Ltd)

EU/3/12/1087 (Richardson Associates Regulatory Affairs Ltd)

EU/3/12/1087 (Active substance: Recombinant modified human growth hormone) - Transfer of orphan designation - Commission Decision (2018)9014 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002652

Europe -DG Health and Food Safety

19-12-2018

Elaprase (Shire Human Genetic Therapies AB)

Elaprase (Shire Human Genetic Therapies AB)

Elaprase (Active substance: Idursulfase) - Centralised - Yearly update - Commission Decision (2018)9067 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

19-12-2018

EU/3/14/1319 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1319 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1319 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9010 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002648

Europe -DG Health and Food Safety

19-12-2018

EU/3/14/1316 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1316 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1316 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9011 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002649

Europe -DG Health and Food Safety

19-12-2018

EU/3/14/1312 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1312 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1312 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9012 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002650

Europe -DG Health and Food Safety