CERVARIX

Informació principal

  • Denominació comercial:
  • CERVARIX 10 jeringas precargadas 0,5 ml
  • formulario farmacéutico:
  • Inyectables
  • Vía de administración:
  • Intramuscular
  • Utilitza per:
  • Humans
  • Tipo de medicina:
  • medicament al·lopàtic

Documents

Localització

  • Disponible en:
  • CERVARIX 10 jeringas precargadas 0,5 ml
    Andorra
  • Idioma:
  • català

Altres dades

Estat

  • Font:
  • CedimCat - Centre d'Informació de Medicaments de Catalunya
  • Número d'autorització:
  • 602851
  • última actualització:
  • 06-06-2018

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

CERVARIX 10 jeringas precargadas 0,5 ml

virus del papiloma humano (16, 18)

Indicacions

Medicament utilitzat per prevenir el c

ncer de c

rvix (VACUNA DEL PAPIL

LOMAVIRUS).

Consideracions

Conservi aquest medicament a la nevera (mai en el congelador).

Aquest medicament ha de ser administrat per via intramuscular.

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.

Efectes adversos

Aquest medicament pot produir envermelliment o mol

sties al punt d'aplicaci

Si not

s qualsevol altre s

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

seu metge.

17-4-2019


Committee for Advanced Therapies (CAT): 16-17 April 2019, European Medicines Agency, Amsterdam, the Netherlands, from 16/04/2019 to 17/04/2019

Committee for Advanced Therapies (CAT): 16-17 April 2019, European Medicines Agency, Amsterdam, the Netherlands, from 16/04/2019 to 17/04/2019

Committee for Advanced Therapies (CAT): 16-17 April 2019, European Medicines Agency, Amsterdam, the Netherlands, from 16/04/2019 to 17/04/2019

Europe - EMA - European Medicines Agency

17-4-2019

Enforcement Report for the Week of April 17, 2019

Enforcement Report for the Week of April 17, 2019

Recently Updated Records for the Week of April 17, 2019 Last Modified Date: Tuesday, April 16, 2019

FDA - U.S. Food and Drug Administration

17-4-2019

Safety and efficacy of Biomin®DC‐C as a zootechnical feed additive for weaned piglets

Safety and efficacy of Biomin®DC‐C as a zootechnical feed additive for weaned piglets

Published on: Tue, 16 Apr 2019 The additive (trade name Biomin® DC‐C) is a blend of essential oils from oregano (Origanum vulgare L.) and from caraway seed (Carum carvi L.) and three individual compounds (carvacrol, methyl salicylate and l‐menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for weaned piglets at a minimum concentration of 75 mg/kg complete feed and a recommended maximum level of 125 mg/kg complete feed. A tolerance test in which piglets were...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-4-2019

Assessment of the application for renewal of authorisation of GalliPro® (Bacillus subtilis DSM 17299) for chickens for fattening

Assessment of the application for renewal of authorisation of GalliPro® (Bacillus subtilis DSM 17299) for chickens for fattening

Published on: Tue, 16 Apr 2019 GalliPro® is the trade name for a feed additive based on viable cells of a strain of Bacillus subtilis intended for use as a zootechnical additive (gut flora stabiliser) in feed for chickens for fattening. The product is currently authorised for use in chickens for fattening. This opinion concerns the renewal of this authorisation. Bacillus subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establish the safety for the t...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-4-2019

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment

FDA today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received antiretroviral treatment for HIV.

FDA - U.S. Food and Drug Administration

4-4-2019

Pest survey card on non‐European isolates of citrus tristeza virus

Pest survey card on non‐European isolates of citrus tristeza virus

Published on: Wed, 03 Apr 2019 This pest survey card was prepared in the context of the EFSA mandate on plant pest surveillance (M‐2017‐0137), at the request of the European Commission. The purpose of the document is to assist the Member States to plan annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with current international standards. The data requirements for such an activity include the pest distribution, its host range, its b...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-3-2019


Paediatric Committee (PDCO): 13-16 November 2018, European Medicines Agency, London, UK, from 13/11/2018 to 16/11/2018

Paediatric Committee (PDCO): 13-16 November 2018, European Medicines Agency, London, UK, from 13/11/2018 to 16/11/2018

Paediatric Committee (PDCO): 13-16 November 2018, European Medicines Agency, London, UK, from 13/11/2018 to 16/11/2018

Europe - EMA - European Medicines Agency

20-3-2019

Enforcement Report for the Week of March 20, 2019

Enforcement Report for the Week of March 20, 2019

Recently Updated Records for the Week of March 20, 2019 Last Modified Date: Monday, March 18, 2019

FDA - U.S. Food and Drug Administration

14-3-2019

Staatssecretaris Blokhuis: komende jaren krijgen alle dak- en thuisloze jongeren hulp

Staatssecretaris Blokhuis: komende jaren krijgen alle dak- en thuisloze jongeren hulp

In een welvarend land als Nederland zou geen enkele jongere op straat moeten leven of noodgedwongen steeds op wisselende plekken verblijven. Met die ambitie lanceert staatssecretaris Paul Blokhuis (VWS) vandaag het Actieprogramma Dak- en Thuisloze Jongeren. De inspanningen moeten ertoe leiden dat alle ruim 10.000 dak- en thuisloze jongeren (tussen de 18 en 27 jaar) de komende jaren geholpen worden naar een zo zelfstandig mogelijk bestaan met een eigen thuis. En dat ook in de toekomst een nieuwe instroom ...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-4-2019


Human medicines European public assessment report (EPAR): Tobramycin PARI, tobramycin, Respiratory Tract Infections,Cystic Fibrosis, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Tobramycin PARI, tobramycin, Respiratory Tract Infections,Cystic Fibrosis, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Tobramycin PARI, tobramycin, Respiratory Tract Infections,Cystic Fibrosis, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Humenza,Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted, decision type: , therapeutic ar

Opinion/decision on a Paediatric investigation plan (PIP): Humenza,Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted, decision type: , therapeutic ar

Opinion/decision on a Paediatric investigation plan (PIP): Humenza,Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted, decision type: , therapeutic area: , PIP number: P/0022/2019

Europe - EMA - European Medicines Agency

16-4-2019


EMA closed 18-22 April 2019

EMA closed 18-22 April 2019

EMA closed 18-22 April 2019

Europe - EMA - European Medicines Agency

15-4-2019

Versican Plus Pi/L4 (Zoetis Belgium S.A.)

Versican Plus Pi/L4 (Zoetis Belgium S.A.)

Versican Plus Pi/L4 (Active substance: Canine parainfluenza virus vaccine (live) and canine leptospirosis vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2964 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3683/R/11

Europe -DG Health and Food Safety

15-4-2019

Suvaxyn PRRS MLV (Zoetis Belgium S.A.)

Suvaxyn PRRS MLV (Zoetis Belgium S.A.)

Suvaxyn PRRS MLV (Active substance: Porcine respiratory and reproductive syndrome virus vaccine (live)) - Centralised - Yearly update - Commission Decision (2019)2995 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019


Orphan designation: Sodium nitrite, Treatment of aneurysmal subarachnoid haemorrhage, 16/01/2014, Positive

Orphan designation: Sodium nitrite, Treatment of aneurysmal subarachnoid haemorrhage, 16/01/2014, Positive

Orphan designation: Sodium nitrite, Treatment of aneurysmal subarachnoid haemorrhage, 16/01/2014, Positive

Europe - EMA - European Medicines Agency

12-4-2019

EU/3/18/2038 (PPD Bulgaria EOOD)

EU/3/18/2038 (PPD Bulgaria EOOD)

EU/3/18/2038 (Active substance: Palovarotene) - Transfer of orphan designation - Commission Decision (2019)2940 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005020

Europe -DG Health and Food Safety

12-4-2019

EU/3/16/1665 (Diamond ROC EOOD)

EU/3/16/1665 (Diamond ROC EOOD)

EU/3/16/1665 (Active substance: Recombinant adeno-associated viral vector containing the human RPGR gene) - Transfer of orphan designation - Commission Decision (2019)2934 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005876

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2124 (IntraBio Ireland Ltd)

EU/3/18/2124 (IntraBio Ireland Ltd)

EU/3/18/2124 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2939 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005404

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2059 (IntraBio Ireland Ltd)

EU/3/18/2059 (IntraBio Ireland Ltd)

EU/3/18/2059 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2938 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005399

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/1977 (GW Pharma (International) B.V)

EU/3/18/1977 (GW Pharma (International) B.V)

EU/3/18/1977 (Active substance: Cannabidivarin) - Transfer of orphan designation - Commission Decision (2019)2929 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004768

Europe -DG Health and Food Safety

12-4-2019

EU/3/16/1621 (GW Pharma (International) B.V)

EU/3/16/1621 (GW Pharma (International) B.V)

EU/3/16/1621 (Active substance: Delta-9-tetrahydrocannabinol and cannabidiol from extracts of the Cannabis sativa L. plant) - Transfer of orphan designation - Commission Decision (2019)2924 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004763

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2126 (JVM Europe B.V.)

EU/3/18/2126 (JVM Europe B.V.)

EU/3/18/2126 (Active substance: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment) - Transfer of orphan designation - Commission Decision (2019)2922 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005194

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2035 (JVM Europe B.V.)

EU/3/18/2035 (JVM Europe B.V.)

EU/3/18/2035 (Active substance: Efpegsomatropin) - Transfer of orphan designation - Commission Decision (2019)2921 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005050

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2022 (JVM Europe B.V.)

EU/3/18/2022 (JVM Europe B.V.)

EU/3/18/2022 (Active substance: Glucagon analogue linked to a human immunoglobulin Fc fragment) - Transfer of orphan designation - Commission Decision 2920 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005277

Europe -DG Health and Food Safety

10-4-2019

Versican Plus DHPPi/L4R (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4R (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4R (Active substance: Canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza virus vaccine (live) and canine leptospirosis and rabies vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2850 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/2759/R/14

Europe -DG Health and Food Safety

10-4-2019

Versican Plus DHPPi/L4 (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4 (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4 (Active substance: Canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza virus vaccine (live) and canine leptospirosis vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2849 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3678/R/13

Europe -DG Health and Food Safety

3-4-2019

EU/3/16/1628 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/16/1628 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/16/1628 (Active substance: Diaspirin cross-linked haemoglobin) - Transfer of orphan designation - Commission Decision (2019)2673 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003473

Europe -DG Health and Food Safety

3-4-2019

EU/3/16/1721 (Araim Pharmaceuticals Europe Limited)

EU/3/16/1721 (Araim Pharmaceuticals Europe Limited)

EU/3/16/1721 (Active substance: L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser) - Transfer of orphan designation - Commission Decision (2019)2676 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005497

Europe -DG Health and Food Safety

3-4-2019

EU/3/16/1648 (Tracon Pharma International Limited)

EU/3/16/1648 (Tracon Pharma International Limited)

EU/3/16/1648 (Active substance: Human/murine chimeric monoclonal antibody against endoglin) - Transfer of orphan designation - Commission Decision (2019)2677 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004633

Europe -DG Health and Food Safety

2-4-2019

EU/3/18/2036 (Regulis Consulting Europe Limited)

EU/3/18/2036 (Regulis Consulting Europe Limited)

EU/3/18/2036 (Active substance: L-cystine bis(N'-methylpiperazide)) - Transfer of orphan designation - Commission Decision (2019)2411 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004889

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

'Meeting your obligations' workshop

'Meeting your obligations' workshop

Registrations are now open for SME Assist's workshop in Melbourne on 16 May 2019

Therapeutic Goods Administration - Australia

29-3-2019

Versican Plus Pi (Zoetis Belgium S.A.)

Versican Plus Pi (Zoetis Belgium S.A.)

Versican Plus Pi (Active substance: Canine parainfluenza virus vaccine (live)) - Centralised - Renewal - Commission Decision (2019)2542 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3681/R/11

Europe -DG Health and Food Safety

29-3-2019

Versican Plus DHPPi (Zoetis Belgium S.A.)

Versican Plus DHPPi (Zoetis Belgium S.A.)

Versican Plus DHPPi (Active substance: Canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza virus vaccine (live)) - Centralised - Renewal - Commission Decision (2019)2543 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3679/R/13

Europe -DG Health and Food Safety

29-3-2019

EU/3/18/2102 (TherAchon SAS)

EU/3/18/2102 (TherAchon SAS)

EU/3/18/2102 (Active substance: Apraglutide) - Transfer of orphan designation - Commission Decision (2019)2415 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004473

Europe -DG Health and Food Safety

29-3-2019

GMP clearance guidance update

GMP clearance guidance update

We have published Version 18.2 of the GMP clearance guidance

Therapeutic Goods Administration - Australia

27-3-2019


Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine: List of nationally authorised medicinal products - PSUSA/00010339/201807

Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine: List of nationally authorised medicinal products - PSUSA/00010339/201807

Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine: List of nationally authorised medicinal products - PSUSA/00010339/201807

Europe - EMA - European Medicines Agency

27-3-2019

EU/3/16/1689 (Boyd Consultants Limited)

EU/3/16/1689 (Boyd Consultants Limited)

EU/3/16/1689 (Active substance: Teriparatide) - Transfer of orphan designation - Commission Decision (2019)2384 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004935

Europe -DG Health and Food Safety

27-3-2019

EU/3/16/1664 (Boyd Consultants Limited)

EU/3/16/1664 (Boyd Consultants Limited)

EU/3/16/1664 (Active substance: Polyethylene glycol-modified human recombinant truncated cystathionine beta-synthase) - Transfer of orphan designation - Commission Decision (2019)2383 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004883

Europe -DG Health and Food Safety

27-3-2019

Rotarix (GlaxoSmithKline Biologicals S.A.)

Rotarix (GlaxoSmithKline Biologicals S.A.)

Rotarix (Active substance: Rotavirus vaccine, live) - PSUSA - Modification - Commission Decision (2019)2396 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2665/201807

Europe -DG Health and Food Safety

27-3-2019

EU/3/16/1711 (Akcea Therapeutics Ireland Limited)

EU/3/16/1711 (Akcea Therapeutics Ireland Limited)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2019)2381 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004196

Europe -DG Health and Food Safety

27-3-2019

EU/3/16/1643 (Clinical Network Services (NL) B.V.)

EU/3/16/1643 (Clinical Network Services (NL) B.V.)

EU/3/16/1643 (Active substance: Autologous stromal vascular cell fraction from adipose tissue) - Transfer of orphan designation - Commission Decision (2019)2405 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005318

Europe -DG Health and Food Safety

26-3-2019

Diacerein (Therapicon Srl)

Diacerein (Therapicon Srl)

Diacerein (Active substance: Diacerein) - Refusal of orphan designation - Commission Decision (2019)2360 of Tue, 26 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/131/18

Europe -DG Health and Food Safety

22-3-2019


Summary of opinion: Innovax-ND-IBD,cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD virus,  21/03/2019,  Positive

Summary of opinion: Innovax-ND-IBD,cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD virus, 21/03/2019, Positive

Summary of opinion: Innovax-ND-IBD,cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD virus, 21/03/2019, Positive

Europe - EMA - European Medicines Agency

19-3-2019

EU/3/18/2101 (TMC Pharma (EU) Limited)

EU/3/18/2101 (TMC Pharma (EU) Limited)

EU/3/18/2101 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2155 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004764

Europe -DG Health and Food Safety

19-3-2019

EU/3/16/1703 (TMC Pharma (EU) Limited)

EU/3/16/1703 (TMC Pharma (EU) Limited)

EU/3/16/1703 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2154 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004730

Europe -DG Health and Food Safety

19-3-2019

EU/3/16/1688 (TMC Pharma (EU) Limited)

EU/3/16/1688 (TMC Pharma (EU) Limited)

EU/3/16/1688 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2153 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004734

Europe -DG Health and Food Safety

19-3-2019

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)2156 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004770

Europe -DG Health and Food Safety

18-3-2019

EU/3/16/1633 (Diamond ROC EOOD)

EU/3/16/1633 (Diamond ROC EOOD)

EU/3/16/1633 (Active substance: Fosbretabulin tromethamine) - Transfer of orphan designation - Commission Decision (2019)2151 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003815

Europe -DG Health and Food Safety

18-3-2019

EU/3/15/1587 (Diamond ROC EOOD)

EU/3/15/1587 (Diamond ROC EOOD)

EU/3/15/1587 (Active substance: Combretastatin A1 diphosphate) - Transfer of orphan designation - Commission Decision (2019)2149 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003811

Europe -DG Health and Food Safety

18-3-2019

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2148 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003801

Europe -DG Health and Food Safety

18-3-2019

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2147 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003809

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

18-3-2019

EU/3/04/195 (Diamond ROC EOOD)

EU/3/04/195 (Diamond ROC EOOD)

EU/3/04/195 (Active substance: 2-Methoxy-5-[(1Z)-2-(3,4,5-trimethoxyphenyl)ethenyl]-phenol) - Transfer of orphan designation - Commission Decision (2019)2144 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003813

Europe -DG Health and Food Safety

18-3-2019

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (Active substance: Human coagulation factor X) - Transfer of orphan designation - Commission Decision (2019)2158 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004129

Europe -DG Health and Food Safety

18-3-2019

EU/3/16/1742 (Worphmed Srl)

EU/3/16/1742 (Worphmed Srl)

EU/3/16/1742 (Active substance: Acebutolol hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2157 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004715

Europe -DG Health and Food Safety

18-3-2019


Orphan designation: Adenovirus-specific T-cells derived from allogeneic donor leukocytes, expanded ex vivo, Treatment of adenovirus infection in allogeneic haematopoietic stem cell transplant recipients, 16/01/2014, Positive

Orphan designation: Adenovirus-specific T-cells derived from allogeneic donor leukocytes, expanded ex vivo, Treatment of adenovirus infection in allogeneic haematopoietic stem cell transplant recipients, 16/01/2014, Positive

Orphan designation: Adenovirus-specific T-cells derived from allogeneic donor leukocytes, expanded ex vivo, Treatment of adenovirus infection in allogeneic haematopoietic stem cell transplant recipients, 16/01/2014, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo-, Treatment of extranodal NK/T-cell lymphoma, nasal type, 14/07/2016, Positive

Orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo-, Treatment of extranodal NK/T-cell lymphoma, nasal type, 14/07/2016, Positive

Orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo-, Treatment of extranodal NK/T-cell lymphoma, nasal type, 14/07/2016, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine - List of nationally authorised medicinal products - PSUSA/00010642/201807

Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine - List of nationally authorised medicinal products - PSUSA/00010642/201807

Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine - List of nationally authorised medicinal products - PSUSA/00010642/201807

Europe - EMA - European Medicines Agency

15-3-2019

Implementation of our reorganization will begin on March 18, with a goal of full implementation being complete by Sept 30. Questions?  The Division of Industry and Consumer Education is ready to help.  https://go.usa.gov/xE6We 

Implementation of our reorganization will begin on March 18, with a goal of full implementation being complete by Sept 30. Questions? The Division of Industry and Consumer Education is ready to help. https://go.usa.gov/xE6We 

Implementation of our reorganization will begin on March 18, with a goal of full implementation being complete by Sept 30. Questions? The Division of Industry and Consumer Education is ready to help. https://go.usa.gov/xE6We 

FDA - U.S. Food and Drug Administration

15-3-2019


Orphan designation: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain, Treatment of glioma, 16/12/2014, Positive

Orphan designation: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain, Treatment of glioma, 16/12/2014, Positive

Orphan designation: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain, Treatment of glioma, 16/12/2014, Positive

Europe - EMA - European Medicines Agency

15-3-2019

EU/3/16/1800 (Boyd Consultants Limited)

EU/3/16/1800 (Boyd Consultants Limited)

EU/3/16/1800 (Active substance: Dantrolene sodium) - Transfer of orphan designation - Commission Decision (2019)2111 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005192

Europe -DG Health and Food Safety

15-3-2019

EU/3/16/1629 (Boyd Consultants Limited)

EU/3/16/1629 (Boyd Consultants Limited)

EU/3/16/1629 (Active substance: Exenatide) - Transfer of orphan designation - Commission Decision (2019)2110 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005191

Europe -DG Health and Food Safety