Insuman

Główne informacje

  • Nazwa własna:
  • Insuman
  • Używać do:
  • Ludzie
  • Typ medycyny:
  • alopatycznych narkotyków

Dokumenty

Lokalizacja

  • Dostępne w:
  • Insuman
    Unia Europejska
  • Język:
  • polski

Informacje terapeutyczne

  • Grupa terapeutyczna:
  • Leki stosowane w cukrzycy,
  • Dziedzina terapeutyczna:
  • Cukrzyca
  • Wskazania:
  • Cukrzyca wymaga leczenia insuliną. Preparat Insuman Rapid nadaje się również do leczenia śpiączki hiperglikemicznej i kwasicy ketonowej, a także do stabilizacji przed-, wewnątrz- i pooperacyjnej u pacjentów z cukrzycą.
  • Podsumowanie produktu:
  • Revision: 26

Inne informacje

Status

  • Źródło:
  • EMA - European Medicines Agency
  • Status autoryzacji:
  • Upoważniony
  • Numer pozwolenia:
  • EMEA/H/C/000201
  • Data autoryzacji:
  • 21-02-1997
  • Kod EMEA:
  • EMEA/H/C/000201
  • Ostatnia aktualizacja:
  • 08-01-2019

Sprawozdanie z oceny publicznego

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.

EMA/477741/2013

EMEA/H/C/000201

Streszczenie EPAR dla ogółu społeczeństwa

Insuman

insulina ludzka

Niniejszy dokument jest streszczeniem Europejskiego Publicznego Sprawozdania Oceniającego (EPAR)

dotyczącego leku Insuman. Wyjaśnia, jak Komitet ds. Produktów Leczniczych Stosowanych u Ludzi

(CHMP) ocenił przeprowadzone badania w celu ustalenia opinii, na podstawie której przyznano

pozwolenie na dopuszczenie produktu Insuman do obrotu, oraz zaleceń w sprawie warunków

stosowania leku.

Co to jest lek Insuman?

Produkty Insuman to seria roztworów i zawiesin insuliny do wstrzyknięć. Lek Insuman jest dostarczany

w fiolkach, kasetach lub w gotowych do użycia jednorazowych wstrzykiwaczach. Seria produktów

Insuman obejmuje:

roztwory szybko działającej insuliny Insuman Rapid, Insuman Infusat i Insuman Implantable,

zawierające insulinę rozpuszczalną,

zawiesinę insuliny o pośrednim czasie działania, Insuman Basal, która zawiera insulinę izofanową,

połączenia insuliny o szybkim i o pośrednim czasie działania w różnych proporcjach, Insuman

Comb.

W jakim celu stosuje się lek Insuman?

Lek Insuman stosuje się u pacjentów z cukrzycą (typu 1 i 2), którzy wymagają leczenia insuliną.

Produkt Insuman 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.

Insuman

EMA/477741/2013

Strona 2/3

Produkt Insuman Implantable stosuje się u dorosłych pacjentów z cukrzycą typu 1, której nie można

kontrolować przy użyciu insuliny podawanej we wstrzyknięciu podskórnym i u których często występują

epizody hiperglikemii lub hipoglikemii (wysoki lub niski poziom cukru we krwi), których nie da się

wyjaśnić.

Lek wydaje się wyłącznie z przepisu lekarza.

Jak stosować lek Insuman?

Produkty Insuman Rapid, Infusat, Basal i Comb 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 produktu Insuman, dawkowanie i harmonogram dokonywania wstrzyknięć; 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

Lek Insuman należy

podawać przed posiłkami. Dokładny czas podawania jest określony w ulotce dla pacjenta.

Produkt Insuman Rapid można także podawać dożylnie, lecz tylko w warunkach intensywnej opieki

medycznej, gdy istnieje możliwość ścisłego monitorowania pacjenta. Produkt Insuman Infusat jest

specjalnie przygotowany i gotowy do podawania w ciągłym wlewie za pomocą zewnętrznej przenośnej

pompy infuzyjnej.

Produkt Insuman Implantable podaje się we wlewie do jamy brzusznej przy użyciu pompy (pompa

implantowana Medtronic MiniMed), którą implantuje się pod skórę brzucha. Produktu Insuman

Implantable nie wolno stosować w inny sposób i można go stosować wyłącznie w ośrodkach, których

personel został odpowiednio przeszkolony w zakresie używania pompy implantowanej.

W celu uzyskania dodatkowych informacji dotyczących sposobu podawania leku Insuman należy

zapoznać się z charakterystyką produktu leczniczego (także część EPAR).

Jak działa lek Insuman?

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

poziomu glukozy we krwi (cukrzyca typu 1) lub w której organizm nie jest w stanie skutecznie

wykorzystywać insuliny (cukrzyca typu 2). Lek Insuman zawiera insulinę zastępczą, która jest podobna

do insuliny wytwarzanej przez organizm.

Substancja czynna leku Insuman, insulina ludzka, jest wytwarzana metodą określaną jako „technologia

rekombinacji DNA”: insulina jest wytwarzana przez bakterie, do których wprowadzono odpowiedni gen

(DNA), umożliwiający im wytwarzanie insuliny. Lek Insuman 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 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 lek Insuman?

Lek Insuman badano w trzech badaniach z udziałem 780 pacjentów z cukrzycą typu 1 lub 2. W jednym

z tych badań lek Insuman podawano pacjentom z cukrzycą typu 1 za pomocą zewnętrznej pompy

insulinowej. W drugim badaniu produkt Insuman Comb 25 porównywano z półsyntetyczną insuliną

Insuman

EMA/477741/2013

Strona 3/3

ludzką u pacjentów z cukrzycą typu 1 i 2. Ponadto badano produkt Insuman Implantable u dorosłych

pacjentów z cukrzycą typu 1. Pacjentom tym podawano produkt Insuman Implantable we ciągłym

wlewie do otrzewnej.

Głównym kryterium oceny skuteczności we wszystkich badaniach była zmiana stężenia

glikozylohemoglobiny (HbA1c), co stanowi udział procentowy hemoglobiny we krwi z dołączoną

glukozą. Poziom HbA1c wskazuje, na ile skutecznie kontrolowany jest poziom glukozy we krwi.

Jakie korzyści ze stosowania leku Insuman zaobserwowano w badaniach?

Lek Insuman spowodował spadek poziomu HbA1c, co wskazuje na podobną kontrolę poziomu glukozy

we krwi, jak w przypadku półsyntetycznej insuliny ludzkiej. Lek Insuman jest skuteczny zarówno w

cukrzycy typu 1, jak i typu 2.

Jakie ryzyko wiąże się ze stosowaniem leku Insuman?

Lek Insuman może powodować hipoglikemię. Pełny wykaz wszystkich działań niepożądanych

związanych ze stosowaniem leku Insuman znajduje się w ulotce dla pacjenta.

Leku Insuman nie wolno stosować u osób, u których występuje nadwrażliwość (alergia) na insulinę

ludzką lub którykolwiek składnik produktu. Prócz tego produktu Insuman Implantable nie wolno

stosować w inny sposób niż we wlewie ciągłym przy użyciu pompy implantowanej Medtronic MiniMed.

Produktu nie wolno również stosować u pacjentów, u których występuje nadwrażliwość na stopy

tytanu, polisulfon lub silikon stosowane do produkcji elementów pompy implantowanej. Pompy nie

wolno używać do podawania żadnych innych rodzajów insuliny ani do wlewu insuliny u dzieci, które nie

osiągnęły jeszcze rozmiarów dorosłego. Pompy nie wolno implantować u osób, które przebywają stale

na wysokości powyżej 2439 metrów.

Na jakiej podstawie zatwierdzono lek Insuman?

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

stosowania leku Insuman przewyższają ryzyko w leczeniu cukrzycy typu 1 i 2. Komitet zalecił

przyznanie pozwolenia na dopuszczenie leku Insuman do obrotu.

Inne informacje dotyczące leku Insuman:

W dniu 21 lutego 1997 r. Komisja Europejska przyznała pozwolenie na dopuszczenie leku Insuman do

obrotu ważne w całej Unii Europejskiej.

Pełne sprawozdanie EPAR dotyczące leku Insuman znajduje się na stronie internetowej Agencji pod

adresem: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. W

celu uzyskania dodatkowych informacji dotyczących leczenia produktem Insuman należy zapoznać się z

ulotką dla pacjenta (także część EPAR) bądź skontaktować się z lekarzem lub farmaceutą.

Data ostatniej aktualizacji: 08.2013.

Ulotkę dla pacjenta: substancji czynnych, wskazania, dawkowanie, interakcje, działania niepożądane, ciąża, laktacja

20-2-2019

Salmonella control in poultry flocks and its public health impact

Salmonella control in poultry flocks and its public health impact

Published on: Mon, 18 Feb 2019 An increase in confirmed human salmonellosis cases in the EU after 2014 triggered investigation of contributory factors and control options in poultry production. Reconsideration of the five current target serovars for breeding hens showed that there is justification for retaining Salmonella Enteritidis, Salmonella Typhimurium (including monophasic variants) and Salmonella Infantis, while Salmonella Virchow and Salmonella Hadar could be replaced by Salmonella Kentucky and ...

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14-2-2019

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

FDA - U.S. Food and Drug Administration

8-2-2019

FDA Announces Second Approved Insulin for Use in Dogs with Diabetes

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FDA - U.S. Food and Drug Administration

1-2-2019

EFSA statement on the risk posed to humans by a vitamin B2 produced by a genetically modified strain of Bacillus subtilis used as a feed additive

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Published on: Thu, 31 Jan 2019 The detection of recombinant DNA in a vitamin B2 used as feed additive was notified by the Belgian national authorities on 2 October 2018 via the Rapid Alert System for Food and Feed (RASFF). The European Commission requested scientific advice from EFSA on the risk posed to humans by the presence of genetically modified material in the feed additive, particularly with regard to antimicrobial resistance (AMR). EFSA assessed the analytical data from RASFF regarding the prese...

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31-1-2019


Electronic product information for human medicines in the European Union – draft key principles

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Europe - EMA - European Medicines Agency

26-1-2019

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Published on: Fri, 25 Jan 2019 Based on the risk assessment of genetically modified plants, according to Implementing Regulation (EU) No 503/201321 “In cases when known functional aspects of the newly expressed protein or structural similarity to known strong adjuvants may indicate possible adjuvant activity, the applicant shall assess the possible role of these proteins as adjuvants”. To further investigate the topic, an EFSA procurement was launched requesting a comprehensive literature review and cri...

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26-1-2019

Overview of available toxicity data for calystegines

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Published on: Fri, 25 Jan 2019 Calystegines are polyhydroxylated nortropane alkaloids that have been found in various solanaceous foods, in particular in potatoes and aubergines. The biological activity and potential toxicity of calystegines are associated with their capacity to inhibit glycosidases and block carbohydrate metabolism inducing lysosomal storage toxicity. The present report summarises the retrieved information on the possible toxicity of calystegines. Only few in vivo short‐term toxicologi...

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25-1-2019


Agenda - Industry stakeholder meeting on Brexit and operation of the centralised procedure for human and veterinary medicine products

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Agenda - Industry stakeholder meeting on Brexit and operation of the centralised procedure for human and veterinary medicine products

Europe - EMA - European Medicines Agency

25-1-2019


Industry stakeholder meeting on Brexit and operation of the centralised procedure for human and veterinary medicine products, European Medicines Agency, London, UK, from 28/01/2019 to 28/01/2019

Industry stakeholder meeting on Brexit and operation of the centralised procedure for human and veterinary medicine products, European Medicines Agency, London, UK, from 28/01/2019 to 28/01/2019

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Europe - EMA - European Medicines Agency

23-1-2019

Foot and mouth disease

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Foot and mouth disease (FMD) is a highly contagious viral infection that is not transmissible to humans. It remains one of the main concerns of livestock farmers and health authorities, due to its potentially huge socio-economic impact. Below is a detailed review of ANSES’s work on FMD.

France - Agence Nationale du Médicament Vétérinaire

21-1-2019

Ruling by the French administrative court of Lyon: ANSES contests any error of assessment

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ANSES has examined the ruling of 15 January 2019 by the French administrative court of Lyon overriding the marketing authorisation decision for Roundup Pro 360. It should be noted that, in order to protect human and environmental health, ANSES is responsible for implementing European regulations on the national level with regard to the marketing authorisation of regulated products (plant protection products, biocides and veterinary medicinal products). It also contributes to improving these regulations b...

France - Agence Nationale du Médicament Vétérinaire

17-1-2019

Assessment of genetically modified maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No 1829‐2003 (application EFSA‐GMO‐NL‐2013‐112)

Assessment of genetically modified maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No 1829‐2003 (application EFSA‐GMO‐NL‐2013‐112)

Published on: Wed, 16 Jan 2019 Maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 89034, 1507, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the four single events and four of their subcombinations and did not identify safety concerns. No new data on the maize single events or their four subcombinations that could lead to modification of the original conclusions on their safety have been identified. Th...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Start onderzoek ‘voltooid leven’

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De Universiteit voor Humanistiek en het Julius Centrum van het UMCU gaan dit jaar samen onderzoek doen naar de omvang en omstandigheden van de groep mensen voor wie de huidige wetgeving geen ruimte lijkt te bieden voor hulp bij een zelfgekozen levenseinde.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-1-2019

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐11

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐11

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Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019


Orphan designation: human apotransferrin, Treatment of beta-thalassaemia intermedia and major, 19/11/2018, Positive

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Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: Glucagon, Treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome, 19/11/2018, Positive

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Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2, Treatment of glioma, 23/08/2017, Positive

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Europe - EMA - European Medicines Agency

18-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

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Europe - EMA - European Medicines Agency

15-2-2019

#ICYMI: FDA authorizes first interoperable insulin pump intended to  allow patients to customize treatment through their individual diabetes  management devices. Read more here:  https://go.usa.gov/xEUuM   #MedicalDevice #FDA

#ICYMI: FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. Read more here: https://go.usa.gov/xEUuM  #MedicalDevice #FDA

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FDA - U.S. Food and Drug Administration

14-2-2019

EU/3/18/1975 (Nightstar Europa Limited)

EU/3/18/1975 (Nightstar Europa Limited)

EU/3/18/1975 (Active substance: Adenovirus-associated viral vector serotype 8 containing the human RPGR gene) - Transfer of orphan designation - Commission Decision (2019)1376 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003405

Europe -DG Health and Food Safety

14-2-2019

EU/3/12/1051 (AstraZeneca AB)

EU/3/12/1051 (AstraZeneca AB)

EU/3/12/1051 (Active substance: Recombinant human lecithin cholesterol acyltransferase) - Transfer of orphan designation - Commission Decision (2019)1365 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003174

Europe -DG Health and Food Safety

14-2-2019

EU/3/12/1094 (BioMarin International Limited)

EU/3/12/1094 (BioMarin International Limited)

EU/3/12/1094 (Active substance: Modified recombinant human C-type natriuretic peptide) - Transfer of orphan designation - Commission Decision (2019)1348 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003587

Europe -DG Health and Food Safety

14-2-2019

EU/3/17/1969 (Maria Livadiotis)

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EU/3/17/1969 (Active substance: Recombinant adeno-associated viral vector serotype 2/1 encoding human beta-hexosaminidase alpha and beta subunits) - Transfer of orphan designation - Commission Decision (2019)1357 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003568

Europe -DG Health and Food Safety

14-2-2019

EU/3/16/1702 (Clinical Network Services (NL) B.V.)

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EU/3/16/1702 (Active substance: Recombinant human monoclonal antibody to insulin receptor) - Transfer of orphan designation - Commission Decision (2019)1372 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003601

Europe -DG Health and Food Safety

14-2-2019

EU/3/15/1499 (Voisin Consulting S.A.R.L.)

EU/3/15/1499 (Voisin Consulting S.A.R.L.)

EU/3/15/1499 (Active substance: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells) - Transfer of orphan designation - Commission Decision (2019)1375 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003671

Europe -DG Health and Food Safety

14-2-2019

EU/3/14/1394 (Pharma Gateway AB)

EU/3/14/1394 (Pharma Gateway AB)

EU/3/14/1394 (Active substance: Pegylated recombinant human hyaluronidase PH20) - Transfer of orphan designation - Commission Decision (2019)1343 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002720

Europe -DG Health and Food Safety

14-2-2019

EU/3/14/1290 (Nightstar Europa Limited)

EU/3/14/1290 (Nightstar Europa Limited)

EU/3/14/1290 (Active substance: Adeno-associated viral vector serotype 2 containing the human REP1 gene) - Transfer of orphan designation - Commission Decision (2019)1361 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003290

Europe -DG Health and Food Safety

13-2-2019


Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive

Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive

Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Humanised single-chain monoclonal antibody against CD37 (otlertuzumab), Treatment chronic lymphocytic leukaemia, 06/12/2012, Positive

Orphan designation: Humanised single-chain monoclonal antibody against CD37 (otlertuzumab), Treatment chronic lymphocytic leukaemia, 06/12/2012, Positive

Orphan designation: Humanised single-chain monoclonal antibody against CD37 (otlertuzumab), Treatment chronic lymphocytic leukaemia, 06/12/2012, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Human medicines highlights - February 2019

Human medicines highlights - February 2019

Human medicines highlights - February 2019

Europe - EMA - European Medicines Agency

5-2-2019


Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Status: Authorised

Europe - EMA - European Medicines Agency

4-2-2019

Privigen (CSL Behring GmbH)

Privigen (CSL Behring GmbH)

Privigen (Active substance: Human normal immunoglobulin (IVIg)) - Centralised - 2-Monthly update - Commission Decision (2019)841 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/831/IB/144

Europe -DG Health and Food Safety

4-2-2019

Respreeza (CSL Behring GmbH)

Respreeza (CSL Behring GmbH)

Respreeza (Active substance: human alpha1-proteinase inhibitor) - Centralised - Yearly update - Commission Decision (2019)842 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

4-2-2019

EU/3/12/1083 (Voisin Consulting S.A.R.L.)

EU/3/12/1083 (Voisin Consulting S.A.R.L.)

EU/3/12/1083 (Active substance: Humanised single chain monoclonal antibody against CD37) - Transfer of orphan designation - Commission Decision (2019)814 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003624

Europe -DG Health and Food Safety

1-2-2019


Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, Date of authorisation: 18/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, Date of authorisation: 18/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, Date of authorisation: 18/12/2018, Status: Authorised

Europe - EMA - European Medicines Agency

1-2-2019


First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Fc- and CDR-modified humanized monoclonal antibody against C5, decision type: , therapeutic area: , PIP number: P/0261/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fc- and CDR-modified humanized monoclonal antibody against C5, decision type: , therapeutic area: , PIP number: P/0261/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fc- and CDR-modified humanized monoclonal antibody against C5, decision type: , therapeutic area: , PIP number: P/0261/2018

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Human fibrinogen concentrate (BT524), decision type: , therapeutic area: , PIP number: P/0285/2018

Opinion/decision on a Paediatric investigation plan (PIP): Human fibrinogen concentrate (BT524), decision type: , therapeutic area: , PIP number: P/0285/2018

Opinion/decision on a Paediatric investigation plan (PIP): Human fibrinogen concentrate (BT524), decision type: , therapeutic area: , PIP number: P/0285/2018

Europe - EMA - European Medicines Agency

31-1-2019


Human medicines European public assessment report (EPAR): Efgratin, pegfilgrastim, Neutropenia, Status: Pending

Human medicines European public assessment report (EPAR): Efgratin, pegfilgrastim, Neutropenia, Status: Pending

Human medicines European public assessment report (EPAR): Efgratin, pegfilgrastim, Neutropenia, Status: Pending

Europe - EMA - European Medicines Agency

31-1-2019


Human medicines European public assessment report (EPAR): Cavoley, pegfilgrastim, Neutropenia, Status: Pending

Human medicines European public assessment report (EPAR): Cavoley, pegfilgrastim, Neutropenia, Status: Pending

Human medicines European public assessment report (EPAR): Cavoley, pegfilgrastim, Neutropenia, Status: Pending

Europe - EMA - European Medicines Agency

31-1-2019


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

30-1-2019

EU/3/16/1609 (Celerion Austria GmbH)

EU/3/16/1609 (Celerion Austria GmbH)

EU/3/16/1609 (Active substance: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s) - Transfer of orphan designation - Commission Decision (2019)234 of Wed, 30 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002887

Europe -DG Health and Food Safety

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

15-1-2019

EU/3/16/1680 (Chugai Pharma France)

EU/3/16/1680 (Chugai Pharma France)

EU/3/16/1680 (Active substance: Humanised anti-IL-6 receptor monoclonal antibody) - Transfer of orphan designation - Commission Decision (2019)229 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003065

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