CLORURO

Informació principal

  • Denominació comercial:
  • CLORURO DE TALIO(201TL) COVIDIEN 213MBq vial 5,8ml
  • Vía de administración:
  • Forma: Viales
  • Utilitza per:
  • Humans
  • Tipo de medicina:
  • medicament al·lopàtic

Documents

Localització

  • Disponible en:
  • CLORURO DE TALIO(201TL) COVIDIEN 213MBq vial 5,8ml
    Andorra
  • Idioma:
  • català

Altres dades

Estat

  • Font:
  • CedimCat - Centre d'Informació de Medicaments de Catalunya
  • Número d'autorització:
  • 661578
  • última actualització:
  • 09-06-2018

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

CLORURO DE TALIO(201TL) COVIDIEN

213MBq vial 5,8ml

talio (Tl-201), cloruro

Indicacions

Medicament que serveix per diagnosticar determinades malalties.

Consideracions

Aquest medicament ha de preparar-se abans de la seva administraci

Ha de rebutjar el medicament 7 dies despr

s de l'obertura de l'env

Aquest medicament ha de ser administrat per via intravenosa.

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.

NO heu de menjar res 4 hores abans d`administrar-vos aquest medicament.

Avisi el seu metge si pateix o ha patit problemes de rony

Alguns medicaments poden modificar l`efic

cia d`aquest f

rmac. NO preneu altres medicaments

sense consultar abans el vostre metge o farmac

utic.

Informi immediatament al seu metge si est

embarassada o creu que pot estar-ho.

Avisi al seu metge si t

algun fill a qui estigui alletant.

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.

Posologia

Li administraran aquest medicament a un centre sanitari.

VIA INTRAVENOSA.

16-2-2019

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

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16-2-2019

Outcome of the consultation with Member States and EFSA on the basic substance application for L‐cysteine for use in plant protection as insecticide

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Published on: Fri, 15 Feb 2019 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for L‐cysteine are presented. The context of the evaluation was that required by ...

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Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Published on: Thu, 14 Feb 2019 Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat‐killed biomass of Yarrowia lipolytica, a yeast species that is widespread in nature and which can be found in the environment as well as in foods. The production process is sufficiently describ...

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Assessment of genetically modified oilseed rape T45 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐012)

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Published on: Thu, 14 Feb 2019 Following the submission of application EFSA‐GMO‐RX‐012 under Regulation (EC) No1829/2003 from BayerCropScienceN.V., the Panelon Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified oilseed rape T45, for food and feed uses, excluding cultivation within the European Unio...

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Staatssecretaris Blokhuis: “Zorgen om normalisering xtc-gebruik”

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14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

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Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

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13-2-2019

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas on findings from the agency’s investigation of the November 2018 outbreak of <em>E. coli</em> O157:H7 in California-linked romaine lettuce

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13-2-2019

Enforcement Report for the Week of February 13, 2019

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13-2-2019

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

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Published on: Tue, 12 Feb 2019 According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance. Among the active substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified 13 active substances for which a review of MRLs i...

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12-2-2019

February 7, 2019: Three Federal Cases Allege Illegal Importation and Sale of ‘Herbal’ Sexual Enhancement Pills that Contained Pharmaceutical Drugs

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12-2-2019

Health Canada will be updating its safety review of breast implants

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11-2-2019


Agenda - PRAC draft agenda of meeting 11-14 February 2019

Agenda - PRAC draft agenda of meeting 11-14 February 2019

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Europe - EMA - European Medicines Agency

11-2-2019


Online training: How to submit an 'Initial Notification' for parallel distribution via IRIS, European Medicines Agency, London, UK, from 31/01/2019 to 31/01/2019

Online training: How to submit an 'Initial Notification' for parallel distribution via IRIS, European Medicines Agency, London, UK, from 31/01/2019 to 31/01/2019

Online training: How to submit an 'Initial Notification' for parallel distribution via IRIS, European Medicines Agency, London, UK, from 31/01/2019 to 31/01/2019

Europe - EMA - European Medicines Agency

11-2-2019


Online training: How to register for access to IRIS, European Medicines Agency, London, UK, from 31/01/2019 to 31/01/2019

Online training: How to register for access to IRIS, European Medicines Agency, London, UK, from 31/01/2019 to 31/01/2019

Online training: How to register for access to IRIS, European Medicines Agency, London, UK, from 31/01/2019 to 31/01/2019

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Otezla,apremilast, decision type: , therapeutic area: , PIP number: P/0398/2018

Opinion/decision on a Paediatric investigation plan (PIP): Otezla,apremilast, decision type: , therapeutic area: , PIP number: P/0398/2018

Opinion/decision on a Paediatric investigation plan (PIP): Otezla,apremilast, decision type: , therapeutic area: , PIP number: P/0398/2018

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15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco,ivacaftor, decision type: , therapeutic area: , PIP number: P/0353/2018

Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco,ivacaftor, decision type: , therapeutic area: , PIP number: P/0353/2018

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Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Europe - EMA - European Medicines Agency

15-2-2019

Consultation: Whether the TGA should publish that a prescription medicine is under evaluation

Consultation: Whether the TGA should publish that a prescription medicine is under evaluation

The TGA is seeking comments from interested parties on this consultation, including what types of prescription medicines should be published. Closing date: 29 March 2019

Therapeutic Goods Administration - Australia

15-2-2019


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Pradaxa,Dabigatran etexilate mesilate, decision type: , therapeutic area: , PIP number: P/0399/2018

Opinion/decision on a Paediatric investigation plan (PIP): Pradaxa,Dabigatran etexilate mesilate, decision type: , therapeutic area: , PIP number: P/0399/2018

Opinion/decision on a Paediatric investigation plan (PIP): Pradaxa,Dabigatran etexilate mesilate, decision type: , therapeutic area: , PIP number: P/0399/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Europe - EMA - European Medicines Agency

15-2-2019

Upcoming changes to permissible indications for listed medicines

Upcoming changes to permissible indications for listed medicines

Subject to the approval of the Delegate of the Minister of Health, this page outlines changes that will be made to the Therapeutic Goods (Permissible Indications) Determination No. 1 of 2018 in February 2019

Therapeutic Goods Administration - Australia

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Lixiana,Edoxaban (tosylate), decision type: , therapeutic area: , PIP number: P/0368/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lixiana,Edoxaban (tosylate), decision type: , therapeutic area: , PIP number: P/0368/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lixiana,Edoxaban (tosylate), decision type: , therapeutic area: , PIP number: P/0368/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx,Secukinumab, decision type: , therapeutic area: , PIP number: P/0372/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx,Secukinumab, decision type: , therapeutic area: , PIP number: P/0372/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx,Secukinumab, decision type: , therapeutic area: , PIP number: P/0372/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cialis,tadalafil, decision type: , therapeutic area: , PIP number: P/0395/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cialis,tadalafil, decision type: , therapeutic area: , PIP number: P/0395/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cialis,tadalafil, decision type: , therapeutic area: , PIP number: P/0395/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Votrient,pazopanib, decision type: , therapeutic area: , PIP number: P/0405/2018

Opinion/decision on a Paediatric investigation plan (PIP): Votrient,pazopanib, decision type: , therapeutic area: , PIP number: P/0405/2018

Opinion/decision on a Paediatric investigation plan (PIP): Votrient,pazopanib, decision type: , therapeutic area: , PIP number: P/0405/2018

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14-2-2019

Yargesa (Piramal Critical Care B.V.)

Yargesa (Piramal Critical Care B.V.)

Yargesa (Active substance: miglustat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1329 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004016/T/0005

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14-2-2019

Buccolam (Shire Services BVBA)

Buccolam (Shire Services BVBA)

Buccolam (Active substance: midazolam) - Centralised - Yearly update - Commission Decision (2019)1337 of Thu, 14 Feb 2019

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14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Evinacumab, decision type: , therapeutic area: , PIP number: P/0404/2018

Opinion/decision on a Paediatric investigation plan (PIP): Evinacumab, decision type: , therapeutic area: , PIP number: P/0404/2018

Opinion/decision on a Paediatric investigation plan (PIP): Evinacumab, decision type: , therapeutic area: , PIP number: P/0404/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Evobrutinib, decision type: , therapeutic area: , PIP number: P/0393/2018

Opinion/decision on a Paediatric investigation plan (PIP): Evobrutinib, decision type: , therapeutic area: , PIP number: P/0393/2018

Opinion/decision on a Paediatric investigation plan (PIP): Evobrutinib, decision type: , therapeutic area: , PIP number: P/0393/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): brigatinib, decision type: , therapeutic area: , PIP number: P/0350/2018

Opinion/decision on a Paediatric investigation plan (PIP): brigatinib, decision type: , therapeutic area: , PIP number: P/0350/2018

Opinion/decision on a Paediatric investigation plan (PIP): brigatinib, decision type: , therapeutic area: , PIP number: P/0350/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Janus Kinase-1 inhibitor (PF-04965842), decision type: , therapeutic area: , PIP number: P/0391/2018

Opinion/decision on a Paediatric investigation plan (PIP): Janus Kinase-1 inhibitor (PF-04965842), decision type: , therapeutic area: , PIP number: P/0391/2018

Opinion/decision on a Paediatric investigation plan (PIP): Janus Kinase-1 inhibitor (PF-04965842), decision type: , therapeutic area: , PIP number: P/0391/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): SER-109 (Eubacterial Spores, Purified Suspension, Encapsulated), decision type: , therapeutic area: , PIP number: P/0390/2018

Opinion/decision on a Paediatric investigation plan (PIP): SER-109 (Eubacterial Spores, Purified Suspension, Encapsulated), decision type: , therapeutic area: , PIP number: P/0390/2018

Opinion/decision on a Paediatric investigation plan (PIP): SER-109 (Eubacterial Spores, Purified Suspension, Encapsulated), decision type: , therapeutic area: , PIP number: P/0390/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): pemigatinib, decision type: , therapeutic area: , PIP number: P/0386/2018

Opinion/decision on a Paediatric investigation plan (PIP): pemigatinib, decision type: , therapeutic area: , PIP number: P/0386/2018

Opinion/decision on a Paediatric investigation plan (PIP): pemigatinib, decision type: , therapeutic area: , PIP number: P/0386/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cenicriviroc, decision type: , therapeutic area: , PIP number: P/0392/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cenicriviroc, decision type: , therapeutic area: , PIP number: P/0392/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cenicriviroc, decision type: , therapeutic area: , PIP number: P/0392/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Calcifediol, decision type: , therapeutic area: , PIP number: P/0339/2018

Opinion/decision on a Paediatric investigation plan (PIP): Calcifediol, decision type: , therapeutic area: , PIP number: P/0339/2018

Opinion/decision on a Paediatric investigation plan (PIP): Calcifediol, decision type: , therapeutic area: , PIP number: P/0339/2018

Europe - EMA - European Medicines Agency

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: Imlifidase, Treatment of anti-glomerular basement membrane disease, 19/11/2018, Positive

Orphan designation: Imlifidase, Treatment of anti-glomerular basement membrane disease, 19/11/2018, Positive

Orphan designation: Imlifidase, Treatment of anti-glomerular basement membrane disease, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase), Prevention of graft rejection following solid organ transplantation, 12/01/2017, Positive

Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase), Prevention of graft rejection following solid organ transplantation, 12/01/2017, Positive

Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase), Prevention of graft rejection following solid organ transplantation, 12/01/2017, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Agammaglobulinaemia tyrosine kinase, Treatment of pemphigus, 12/12/2017, Positive

Orphan designation: Agammaglobulinaemia tyrosine kinase, Treatment of pemphigus, 12/12/2017, Positive

Orphan designation: Agammaglobulinaemia tyrosine kinase, Treatment of pemphigus, 12/12/2017, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: 2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl) acetamide, Treatment of cystic fibrosis, 21/05/2015, Positive

Orphan designation: 2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl) acetamide, Treatment of cystic fibrosis, 21/05/2015, Positive

Orphan designation: 2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl) acetamide, Treatment of cystic fibrosis, 21/05/2015, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Alecensa,Alectinib, decision type: , therapeutic area: , PIP number: P/0359/2018

Opinion/decision on a Paediatric investigation plan (PIP): Alecensa,Alectinib, decision type: , therapeutic area: , PIP number: P/0359/2018

Opinion/decision on a Paediatric investigation plan (PIP): Alecensa,Alectinib, decision type: , therapeutic area: , PIP number: P/0359/2018

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Flurpiridaz F18, decision type: , therapeutic area: , PIP number: P/0396/2018

Opinion/decision on a Paediatric investigation plan (PIP): Flurpiridaz F18, decision type: , therapeutic area: , PIP number: P/0396/2018

Opinion/decision on a Paediatric investigation plan (PIP): Flurpiridaz F18, decision type: , therapeutic area: , PIP number: P/0396/2018

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin,Ezetimibe, decision type: , therapeutic area: , PIP number: P/0374/2018

Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin,Ezetimibe, decision type: , therapeutic area: , PIP number: P/0374/2018

Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin,Ezetimibe, decision type: , therapeutic area: , PIP number: P/0374/2018

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ipatasertib, decision type: , therapeutic area: , PIP number: P/0383/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ipatasertib, decision type: , therapeutic area: , PIP number: P/0383/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ipatasertib, decision type: , therapeutic area: , PIP number: P/0383/2018

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

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Molibresib, decision type: , therapeutic area: , PIP number: P/0375/2018

Opinion/decision on a Paediatric investigation plan (PIP): Molibresib, decision type: , therapeutic area: , PIP number: P/0375/2018

Opinion/decision on a Paediatric investigation plan (PIP): Molibresib, decision type: , therapeutic area: , PIP number: P/0375/2018

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Avadomide, decision type: , therapeutic area: , PIP number: P/0379/2018

Opinion/decision on a Paediatric investigation plan (PIP): Avadomide, decision type: , therapeutic area: , PIP number: P/0379/2018

Opinion/decision on a Paediatric investigation plan (PIP): Avadomide, decision type: , therapeutic area: , PIP number: P/0379/2018

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, decision type: , therapeutic area: , PIP number: P/0382/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, decision type: , therapeutic area: , PIP number: P/0382/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, decision type: , therapeutic area: , PIP number: P/0382/2018

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Selinexor, decision type: , therapeutic area: , PIP number: P/0384/2018

Opinion/decision on a Paediatric investigation plan (PIP): Selinexor, decision type: , therapeutic area: , PIP number: P/0384/2018

Opinion/decision on a Paediatric investigation plan (PIP): Selinexor, decision type: , therapeutic area: , PIP number: P/0384/2018

Europe - EMA - European Medicines Agency

13-2-2019

Consultation: Regulation of software, including Software as a Medical Device (SaMD)

Consultation: Regulation of software, including Software as a Medical Device (SaMD)

The TGA is seeking feedback on how software, including Software as a Medical Device, is regulated in Australia. Closing date: 31 March 2019

Therapeutic Goods Administration - Australia

12-2-2019

Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

The TGA is seeking feedback on how personalised medical devices are regulated in Australia. Closing date: 31 March 2019

Therapeutic Goods Administration - Australia

12-2-2019

Vaxxitek HVT + IBD (Merial)

Vaxxitek HVT + IBD (Merial)

Vaxxitek HVT + IBD (Active substance: Live vHVT013-69 recombinant virus) - Centralised - Yearly update - Commission Decision (2019)1098 of Tue, 12 Feb 2019

Europe -DG Health and Food Safety

12-2-2019

Halagon (Emdoka bvba)

Halagon (Emdoka bvba)

Halagon (Active substance: halofuginone) - Centralised - Yearly update - Commission Decision (2019)1095 of Tue, 12 Feb 2019

Europe -DG Health and Food Safety

12-2-2019

Helicobacter Test INFAI (INFAI GmbH)

Helicobacter Test INFAI (INFAI GmbH)

Helicobacter Test INFAI (Active substance: 13C - urea) - Centralised - Yearly update - Commission Decision (2019)1109 of Tue, 12 Feb 2019

Europe -DG Health and Food Safety

12-2-2019

Kriptazen (Virbac)

Kriptazen (Virbac)

Kriptazen (Active substance: halofuginone) - Centralised - Authorisation - Commission Decision (2019)1097 of Tue, 12 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4868

Europe -DG Health and Food Safety

12-2-2019

Vectra Felis (Ceva SantE Animale)

Vectra Felis (Ceva SantE Animale)

Vectra Felis (Active substance: dinotefuran, pyriproxyfen) - Centralised - Renewal - Commission Decision (2019)1096 of Tue, 12 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/2746/R/08

Europe -DG Health and Food Safety

11-2-2019

Tarceva (Roche Registration GmbH)

Tarceva (Roche Registration GmbH)

Tarceva (Active substance: Erlotinib) - Centralised - Yearly update - Commission Decision (2019)1073 of Mon, 11 Feb 2019

Europe -DG Health and Food Safety

11-2-2019

Dasselta (Krka d. d., Novo mesto)

Dasselta (Krka d. d., Novo mesto)

Dasselta (Active substance: desloratadine) - Centralised - Yearly update - Commission Decision (2019)1072 of Mon, 11 Feb 2019

Europe -DG Health and Food Safety

11-2-2019

Sycrest (Organon N.V.)

Sycrest (Organon N.V.)

Sycrest (Active substance: asenapine) - Centralised - Yearly update - Commission Decision (2019)1075 of Mon, 11 Feb 2019

Europe -DG Health and Food Safety

11-2-2019

Raxone (Santhera Pharmaceuticals (Deutschland) GmbH)

Raxone (Santhera Pharmaceuticals (Deutschland) GmbH)

Raxone (Active substance: idebenone) - Centralised - Yearly update - Commission Decision (2019)1074 of Mon, 11 Feb 2019

Europe -DG Health and Food Safety

11-2-2019

Tolucombi (Krka d. d., Novo mesto)

Tolucombi (Krka d. d., Novo mesto)

Tolucombi (Active substance: telmisartan/hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2019)1040 of Mon, 11 Feb 2019

Europe -DG Health and Food Safety