PROLASTINA

Informació principal

  • Denominació comercial:
  • PROLASTINA 1 g 1 vial polvo + 1 vial disolvente
  • Vía de administración:
  • Forma: Viales
  • Utilitza per:
  • Humans
  • Tipo de medicina:
  • medicament al·lopàtic

Documents

Localització

  • Disponible en:
  • PROLASTINA 1 g 1 vial polvo + 1 vial disolvente
    Andorra
  • Idioma:
  • català

Altres dades

Estat

  • Font:
  • CedimCat - Centre d'Informació de Medicaments de Catalunya
  • Número d'autorització:
  • 656186
  • última actualització:
  • 08-06-2018

Prospecte: composició, indicacions, interacció, posologia, embaràs, lactància, reaccions adverses

PROLASTINA 1 g 1 vial polvo + 1 vial disolvente

alfa-1-antitripsina

Indicacions

Medicament utilitzat per tractar certes malalties respirat

ries.

Consideracions

Aquest medicament ha de ser administrat per infusi

intravenosa lenta en un centre sanitari.

Aquest medicament ha de ser administrat per un metge o un altre professional sanitari amb experi

ncia.

Aquest medicament

s d'un sol

s; rebutgi qualsevol resta de medicament que pugui quedar a l'env

s una vegada utilitzat.

Avisi el seu metge si pateix o ha patit problemes de cor.

NO fumi en absolut mentre prengui aquest medicament.

Informi immediatament el seu metge si est

embarassada o creu que pot estar-ho, aix

com si qued

s embarassada durant el tractament.

Avisi al seu metge si t

algun fill a qui estigui alletant.

Efectes adversos

Encara que

s poc freq

ent, AVISI el seu metge si durant el tractament li aparegu

s mal al pit,

ritme del cor accelerat, algun mareig, erupcions cut

nies, picor i dificultat per respirar.

Si not

s qualsevol altre s

mptoma que creu que pot ser causat per aquest medicament, digui-li-ho al

seu metge.

Posologia

Li administraran aquest medicament a un centre sanitari.

Administrar 1 injectable cada setmana (sempre el mateix dia de la setmana).

VIA INTRAVENOSA LENTA.

13-3-2019

Pest categorisation of Phymatotrichopsis omnivora

Pest categorisation of Phymatotrichopsis omnivora

Published on: Tue, 12 Mar 2019 The Panel on Plant Health performed a pest categorisation of Phymatotrichopsis omnivora, the causal agent of Phymatotrichum root rot of more than 2,000 dicotyledonous plant species, for the EU. The pest is listed as Trechispora brinkmannii in Annex IAI of Directive 2000/29/EC. P. omnivora is a well‐defined fungal species and reliable methods exist for its detection and identification. It is present in south‐western USA, northern Mexico, Libya and Venezuela. The pest is not...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

12-4-2019


Orphan designation: Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A, Treatment of myasthenia gravis, 21/0

Orphan designation: Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A, Treatment of myasthenia gravis, 21/0

Orphan designation: Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A, Treatment of myasthenia gravis, 21/05/2015, Withdrawn

Europe - EMA - European Medicines Agency

12-4-2019

EU/3/07/440 (Diamond ROC EOOD)

EU/3/07/440 (Diamond ROC EOOD)

EU/3/07/440 (Active substance: Recombinant adeno-associated viral vector containing human alpha-1 antitrypsin gene) - Transfer of orphan designation - Commission Decision (2019)2930 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005871

Europe -DG Health and Food Safety

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Turoctocog alfa pegol, decision type: , therapeutic area: , PIP number: P/0046/2019

Opinion/decision on a Paediatric investigation plan (PIP): Turoctocog alfa pegol, decision type: , therapeutic area: , PIP number: P/0046/2019

Opinion/decision on a Paediatric investigation plan (PIP): Turoctocog alfa pegol, decision type: , therapeutic area: , PIP number: P/0046/2019

Europe - EMA - European Medicines Agency

3-4-2019

EU/3/19/2151 (Voisin Consulting S.A.R.L.)

EU/3/19/2151 (Voisin Consulting S.A.R.L.)

EU/3/19/2151 (Active substance: Marzeptacog alfa (activated)) - Orphan designation - Commission Decision (2019)2667 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002304

Europe -DG Health and Food Safety

1-4-2019

EU/3/18/2000 (Amicus Therapeutics Europe Limited)

EU/3/18/2000 (Amicus Therapeutics Europe Limited)

EU/3/18/2000 (Active substance: Recombinant human acid alpha-glucosidase) - Transfer of orphan designation - Commission Decision (2019)2423 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004425

Europe -DG Health and Food Safety

1-4-2019

VPRIV (Shire Pharmaceuticals Ireland Limited)

VPRIV (Shire Pharmaceuticals Ireland Limited)

VPRIV (Active substance: Velaglucerase alfa) - Centralised - Yearly update - Commission Decision (2019)2575 of Mon, 01 Apr 2019

Europe -DG Health and Food Safety

27-3-2019

ADYNOVI (Baxalta Innovations GmbH)

ADYNOVI (Baxalta Innovations GmbH)

ADYNOVI (Active substance: rurioctocog alfa pegol) - Centralised - Yearly update - Commission Decision (2019)2378 of Wed, 27 Mar 2019

Europe -DG Health and Food Safety

18-3-2019

EU/3/14/1247 (Diamond ROC EOOD)

EU/3/14/1247 (Diamond ROC EOOD)

EU/3/14/1247 (Active substance: Autologous dendritic cells pulsed with tumour antigen-derived synthetic peptides (MAGE-1, HER-2, AIM-2, TRP-2, gp-100, and interleukin-13 receptor alpha)) - Transfer of orphan designation - Commission Decision (2019)2146 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003818

Europe -DG Health and Food Safety

8-3-2019

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Active substance: Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin) - Transfer of orphan designation - Commission Decision (2019)1940 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004447

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/545 (Clinuvel Europe Limited)

EU/3/08/545 (Clinuvel Europe Limited)

EU/3/08/545 (Active substance: [Nle4, D-Phe7]-alpha-melanocyte stimulating hormone) - Transfer of orphan designation - Commission Decision (2019)1948 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004293

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/541 (Clinuvel Europe Limited)

EU/3/08/541 (Clinuvel Europe Limited)

EU/3/08/541 (Active substance: [Nle4, D-Phe7]-alpha-melanocyte stimulating hormone) - Transfer of orphan designation - Commission Decision (2019)1947 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004019

Europe -DG Health and Food Safety

1-3-2019


Summary of opinion: Ondexxya,andexanet alfa,  28/02/2019,  Positive

Summary of opinion: Ondexxya,andexanet alfa, 28/02/2019, Positive

Summary of opinion: Ondexxya,andexanet alfa, 28/02/2019, Positive

Europe - EMA - European Medicines Agency

27-2-2019

AFSTYLA (CSL Behring GmbH)

AFSTYLA (CSL Behring GmbH)

AFSTYLA (Active substance: lonoctocog alfa) - Centralised - Yearly update - Commission Decision (2019)1671 of Wed, 27 Feb 2019

Europe -DG Health and Food Safety

22-2-2019

Eurartesim (Alfasigma S.p.A.)

Eurartesim (Alfasigma S.p.A.)

Eurartesim (Active substance: piperaquine tetraphosphate/artenimol) - PSUSA - Modification - Commission Decision (2019)1579 of Fri, 22 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00001069/201804

Europe -DG Health and Food Safety

22-2-2019


Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa), Treatment of pancreatic cancer, 16/12/2014, Positive

Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa), Treatment of pancreatic cancer, 16/12/2014, Positive

Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa), Treatment of pancreatic cancer, 16/12/2014, Positive

Europe - EMA - European Medicines Agency

20-2-2019

ATryn (Laboratoire franCais du Fractionnement et des Biotechnologies)

ATryn (Laboratoire franCais du Fractionnement et des Biotechnologies)

ATryn (Active substance: antithrombin alfa) - Centralised - Annual reassessment - Commission Decision (2019)1509 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/587/S/35

Europe -DG Health and Food Safety

19-2-2019


Orphan designation: cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate, Treatment of cystic fibrosis, 19/11/2018, Positive

Orphan designation: cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate, Treatment of cystic fibrosis, 19/11/2018, Positive

Orphan designation: cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate, Treatment of cystic fibrosis, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

19-2-2019

Besremi (AOP Orphan Pharmaceuticals AG)

Besremi (AOP Orphan Pharmaceuticals AG)

Besremi (Active substance: ropeginterferon alfa-2b) - Centralised - Authorisation - Commission Decision (2019)1455 of Tue, 19 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4128/00

Europe -DG Health and Food Safety

18-2-2019

EU/3/17/1955 (TxCell S.A.)

EU/3/17/1955 (TxCell S.A.)

EU/3/17/1955 (Active substance: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene) - Transfer of orphan designation - Commission Decision (2019)1370 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003576

Europe -DG Health and Food Safety

14-2-2019

EU/3/17/1969 (Maria Livadiotis)

EU/3/17/1969 (Maria Livadiotis)

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

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Alprolix,eftrenonacog alfa, decision type: , therapeutic area: , PIP number: P/0296/2018

Opinion/decision on a Paediatric investigation plan (PIP): Alprolix,eftrenonacog alfa, decision type: , therapeutic area: , PIP number: P/0296/2018

Opinion/decision on a Paediatric investigation plan (PIP): Alprolix,eftrenonacog alfa, decision type: , therapeutic area: , PIP number: P/0296/2018

Europe - EMA - European Medicines Agency

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

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): andexanet alfa, decision type: , therapeutic area: , PIP number: P/0243/2018

Opinion/decision on a Paediatric investigation plan (PIP): andexanet alfa, decision type: , therapeutic area: , PIP number: P/0243/2018

Opinion/decision on a Paediatric investigation plan (PIP): andexanet alfa, decision type: , therapeutic area: , PIP number: P/0243/2018

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

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Olipudase alfa, decision type: , therapeutic area: , PIP number: P/0258/2018

Opinion/decision on a Paediatric investigation plan (PIP): Olipudase alfa, decision type: , therapeutic area: , PIP number: P/0258/2018

Opinion/decision on a Paediatric investigation plan (PIP): Olipudase alfa, decision type: , therapeutic area: , PIP number: P/0258/2018

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

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ruconest,Conestat alfa, decision type: , therapeutic area: , PIP number: P/0343/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ruconest,Conestat alfa, decision type: , therapeutic area: , PIP number: P/0343/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ruconest,Conestat alfa, decision type: , therapeutic area: , PIP number: P/0343/2018

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

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Anti-alpha synuclein monoclonal antibody (BIIB054), decision type: , therapeutic area: , PIP number: P/0278/2018

Opinion/decision on a Paediatric investigation plan (PIP): Anti-alpha synuclein monoclonal antibody (BIIB054), decision type: , therapeutic area: , PIP number: P/0278/2018

Opinion/decision on a Paediatric investigation plan (PIP): Anti-alpha synuclein monoclonal antibody (BIIB054), decision type: , therapeutic area: , PIP number: P/0278/2018

Europe - EMA - European Medicines Agency

16-1-2019

Ovaleap (Theramex Ireland Limited)

Ovaleap (Theramex Ireland Limited)

Ovaleap (Active substance: Follitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)189 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002608/T/0027

Europe -DG Health and Food Safety

11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019

Strensiq (Alexion Europe SAS)

Strensiq (Alexion Europe SAS)

Strensiq (Active substance: asfotase alfa) - Centralised - Yearly update - Commission Decision (2019)69 of Thu, 10 Jan 2019

Europe -DG Health and Food Safety

27-12-2018

Vihuma (Octapharma AB)

Vihuma (Octapharma AB)

Vihuma (Active substance: simoctocog alfa) - Centralised - Variation - Commission Decision (2018)9196 of Thu, 27 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4459/X/6/G

Europe -DG Health and Food Safety

14-12-2018


Summary of opinion: Besremi,ropeginterferon alfa-2b,  13/12/2018,  Positive

Summary of opinion: Besremi,ropeginterferon alfa-2b, 13/12/2018, Positive

Summary of opinion: Besremi,ropeginterferon alfa-2b, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

12-12-2018

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Active substance: efmoroctocog alfa) - Centralised - Variation - Commission Decision (2018)8678 of Wed, 12 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3964/X/21

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): vonicog alfa, decision type: , therapeutic area: , PIP number: P/0225/2018

Opinion/decision on a Paediatric investigation plan (PIP): vonicog alfa, decision type: , therapeutic area: , PIP number: P/0225/2018

Opinion/decision on a Paediatric investigation plan (PIP): vonicog alfa, decision type: , therapeutic area: , PIP number: P/0225/2018

Europe - EMA - European Medicines Agency

26-11-2018

Jivi (Bayer AG)

Jivi (Bayer AG)

Jivi (Active substance: damoctocog alfa pegol) - Centralised - Authorisation - Commission Decision (2018)7987 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004054/0000

Europe -DG Health and Food Safety

22-11-2018

Brineura (BioMarin International Limited)

Brineura (BioMarin International Limited)

Brineura (Active substance: cerliponase alfa) - Centralised - Yearly update - Commission Decision (2018)7885 of Thu, 22 Nov 2018

Europe -DG Health and Food Safety

22-11-2018

NovoSeven (Novo Nordisk A/S)

NovoSeven (Novo Nordisk A/S)

NovoSeven (Active substance: Eptacog alfa (activated)) - Centralised - 2-Monthly update - Commission Decision (2018)7877 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000074/II/0104

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate) - Orphan designation - Commission Decision (2018)7795 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/106/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/10/726 (Pfizer Europe MA EEIG)

EU/3/10/726 (Pfizer Europe MA EEIG)

EU/3/10/726 (Active substance: Taliglucerase alfa) - Transfer of orphan designation - Commission Decision (2018)7830 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/125/09/T/02

Europe -DG Health and Food Safety

14-11-2018

Caring for a loved one? Be prepared for any situation. 4 tips to help you keep you loved one safe:  http://www.fda.gov/caregivertips  #NationalFamilyCaregiversMonthpic.twitter.com/DpNpz8NCDe

Caring for a loved one? Be prepared for any situation. 4 tips to help you keep you loved one safe: http://www.fda.gov/caregivertips  #NationalFamilyCaregiversMonthpic.twitter.com/DpNpz8NCDe

Caring for a loved one? Be prepared for any situation. 4 tips to help you keep you loved one safe: http://www.fda.gov/caregivertips  #NationalFamilyCaregiversMonth pic.twitter.com/DpNpz8NCDe

FDA - U.S. Food and Drug Administration

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

Ruconest (Active substance: Conestat alfa) - Centralised - Yearly update - Commission Decision (2018)7548 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

29-10-2018

Replagal (Shire Human Genetic Therapies AB)

Replagal (Shire Human Genetic Therapies AB)

Replagal (Active substance: Agalsidase alfa) - Centralised - Yearly update - Commission Decision (2018)7250 of Mon, 29 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

PegIntron (Merck Sharp and Dohme B.V.)

PegIntron (Merck Sharp and Dohme B.V.)

PegIntron (Active substance: Peginterferon alfa-2b) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6484 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/280/T/135

Europe -DG Health and Food Safety

2-10-2018

Vimizim (BioMarin International Limited)

Vimizim (BioMarin International Limited)

Vimizim (Active substance: elosulfase alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6491 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002779/T/0026

Europe -DG Health and Food Safety

2-10-2018

ViraferonPeg (Merck Sharp and Dohme B.V.)

ViraferonPeg (Merck Sharp and Dohme B.V.)

ViraferonPeg (Active substance: Peginterferon alfa-2b) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6477 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/329/T/128

Europe -DG Health and Food Safety

2-10-2018

IntronA (Merck Sharp and Dohme B.V.)

IntronA (Merck Sharp and Dohme B.V.)

IntronA (Active substance: Interferon alfa-2b) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6487 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/281/T/116

Europe -DG Health and Food Safety

24-9-2018

Kanuma (Alexion Europe SAS)

Kanuma (Alexion Europe SAS)

Kanuma (Active substance: sebelipase alfa) - Centralised - Yearly update - Commission Decision (2018)6245 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Active substance: Choriogonadotrophin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6220 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/320/T/75

Europe -DG Health and Food Safety