RIC.N.13 H.S CORONE POLICARBONATO

Informazioni principali

  • Nome commerciale:
  • RIC.N.13 H.S CORONE POLICARBONATO
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Dispositivo medico

Documenti

  • per il pubblico:
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  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


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Localizzazione

  • Disponibile in:
  • RIC.N.13 H.S CORONE POLICARBONATO
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • RESINE E CORONE DENTALI

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • S
  • Data dell'autorizzazione:
  • 17-03-2010
  • Ultimo aggiornamento:
  • 09-08-2016
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.

    Richiedi il foglio illustrativo per il pubblico.

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy

FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy

FDA approved the first generic version of Sabril for treating complex partial seizures, as an adjunctive therapy in certain patients.

FDA - U.S. Food and Drug Administration

4-1-2019

Shamrock Farms Issues Voluntary Recall of 2% Reduced Fat Vanilla Half Gallon Milk Due to Undeclared Almonds

Shamrock Farms Issues Voluntary Recall of 2% Reduced Fat Vanilla Half Gallon Milk Due to Undeclared Almonds

Shamrock Farms of Phoenix, Arizona is issuing a voluntary recall of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Best Before Date 3/16/2019. The recall comes after a product retain of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Use By 03/16/19 Time Stamp 08:18-11:13 04-05 #1, tested positive for an undeclared tree nut (almond) allergen.

FDA - U.S. Food and Drug Administration

31-12-2018

Woodlot Shop Inc. recalls 13.5 oz Candles

Woodlot Shop Inc. recalls 13.5 oz Candles

Once the candle has been lit, there is a risk of the glass jar cracking which may pose a laceration hazard and a risk of wax spilling which may pose a burn or fire hazard.

Health Canada

21-12-2018

FDA approves first treatment for rare blood disease

FDA approves first treatment for rare blood disease

The FDA approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.

FDA - U.S. Food and Drug Administration

17-12-2018

December 13, 2018: Owner and Four Former Employees of New England Compounding Center Convicted Following Trial

December 13, 2018: Owner and Four Former Employees of New England Compounding Center Convicted Following Trial

December 13, 2018: Owner and Four Former Employees of New England Compounding Center Convicted Following Trial

FDA - U.S. Food and Drug Administration

17-12-2018

December 13, 2018: Floridian Pleads Guilty in Complex Fraud Scheme Related to the Processing of Credit Card Payments

December 13, 2018: Floridian Pleads Guilty in Complex Fraud Scheme Related to the Processing of Credit Card Payments

December 13, 2018: Floridian Pleads Guilty in Complex Fraud Scheme Related to the Processing of Credit Card Payments

FDA - U.S. Food and Drug Administration

14-12-2018


Management Board meeting: 12-13 December 2018, European Medicines Agency, London, UK, from 12/12/2018 to 13/12/2018

Management Board meeting: 12-13 December 2018, European Medicines Agency, London, UK, from 12/12/2018 to 13/12/2018

Management Board meeting: 12-13 December 2018, European Medicines Agency, London, UK, from 12/12/2018 to 13/12/2018

Europe - EMA - European Medicines Agency

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cell-free solution of lysed Escherichia coli culture, strain Laves, decision type: , therapeutic area: , PIP number: P/0328/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cell-free solution of lysed Escherichia coli culture, strain Laves, decision type: , therapeutic area: , PIP number: P/0328/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cell-free solution of lysed Escherichia coli culture, strain Laves, decision type: , therapeutic area: , PIP number: P/0328/2018

Europe - EMA - European Medicines Agency

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Pamiparib, decision type: , therapeutic area: , PIP number: P/0329/2018

Opinion/decision on a Paediatric investigation plan (PIP): Pamiparib, decision type: , therapeutic area: , PIP number: P/0329/2018

Opinion/decision on a Paediatric investigation plan (PIP): Pamiparib, decision type: , therapeutic area: , PIP number: P/0329/2018

Europe - EMA - European Medicines Agency

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Eflapegrastim, decision type: , therapeutic area: , PIP number: P/0336/2018

Opinion/decision on a Paediatric investigation plan (PIP): Eflapegrastim, decision type: , therapeutic area: , PIP number: P/0336/2018

Opinion/decision on a Paediatric investigation plan (PIP): Eflapegrastim, decision type: , therapeutic area: , PIP number: P/0336/2018

Europe - EMA - European Medicines Agency

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Omega-3-acid ethyl esters 90 / rosuvastatin (calcium), decision type: , therapeutic area: , PIP number: P/0309/2018

Opinion/decision on a Paediatric investigation plan (PIP): Omega-3-acid ethyl esters 90 / rosuvastatin (calcium), decision type: , therapeutic area: , PIP number: P/0309/2018

Opinion/decision on a Paediatric investigation plan (PIP): Omega-3-acid ethyl esters 90 / rosuvastatin (calcium), decision type: , therapeutic area: , PIP number: P/0309/2018

Europe - EMA - European Medicines Agency

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous dendritic cells pulsed with allogeneic tumour cell lysate, decision type: , therapeutic area: , PIP number: P/0334/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous dendritic cells pulsed with allogeneic tumour cell lysate, decision type: , therapeutic area: , PIP number: P/0334/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous dendritic cells pulsed with allogeneic tumour cell lysate, decision type: , therapeutic area: , PIP number: P/0334/2018

Europe - EMA - European Medicines Agency

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Empliciti,Elotuzumab, decision type: , therapeutic area: , PIP number: P/0267/2018

Opinion/decision on a Paediatric investigation plan (PIP): Empliciti,Elotuzumab, decision type: , therapeutic area: , PIP number: P/0267/2018

Opinion/decision on a Paediatric investigation plan (PIP): Empliciti,Elotuzumab, decision type: , therapeutic area: , PIP number: P/0267/2018

Europe - EMA - European Medicines Agency

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Nadofaragene firadenovec, decision type: , therapeutic area: , PIP number: P/0276/2018

Opinion/decision on a Paediatric investigation plan (PIP): Nadofaragene firadenovec, decision type: , therapeutic area: , PIP number: P/0276/2018

Opinion/decision on a Paediatric investigation plan (PIP): Nadofaragene firadenovec, decision type: , therapeutic area: , PIP number: P/0276/2018

Europe - EMA - European Medicines Agency

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Levofloxacin / dexamethasone, decision type: , therapeutic area: , PIP number: P/0277/2018

Opinion/decision on a Paediatric investigation plan (PIP): Levofloxacin / dexamethasone, decision type: , therapeutic area: , PIP number: P/0277/2018

Opinion/decision on a Paediatric investigation plan (PIP): Levofloxacin / dexamethasone, decision type: , therapeutic area: , PIP number: P/0277/2018

Europe - EMA - European Medicines Agency

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

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Acetylsalicylic acid / rosuvastatin (calcium) / perindopril (tert-butylamine) / indapamide (hemihydrate), decision type: , therapeutic area: , PIP number: P/0311/2018

Opinion/decision on a Paediatric investigation plan (PIP): Acetylsalicylic acid / rosuvastatin (calcium) / perindopril (tert-butylamine) / indapamide (hemihydrate), decision type: , therapeutic area: , PIP number: P/0311/2018

Opinion/decision on a Paediatric investigation plan (PIP): Acetylsalicylic acid / rosuvastatin (calcium) / perindopril (tert-butylamine) / indapamide (hemihydrate), decision type: , therapeutic area: , PIP number: P/0311/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): 3-(3-(3,5-Dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid, decision type: , therapeutic area: , PIP number: P/0330/2018

Opinion/decision on a Paediatric investigation plan (PIP): 3-(3-(3,5-Dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid, decision type: , therapeutic area: , PIP number: P/0330/2018

Opinion/decision on a Paediatric investigation plan (PIP): 3-(3-(3,5-Dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid, decision type: , therapeutic area: , PIP number: P/0330/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Telisotuzumab vedotin, decision type: , therapeutic area: , PIP number: P/0331/2018

Opinion/decision on a Paediatric investigation plan (PIP): Telisotuzumab vedotin, decision type: , therapeutic area: , PIP number: P/0331/2018

Opinion/decision on a Paediatric investigation plan (PIP): Telisotuzumab vedotin, decision type: , therapeutic area: , PIP number: P/0331/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Irbesartan / amlodipine, decision type: , therapeutic area: , PIP number: P/0245/2018

Opinion/decision on a Paediatric investigation plan (PIP): Irbesartan / amlodipine, decision type: , therapeutic area: , PIP number: P/0245/2018

Opinion/decision on a Paediatric investigation plan (PIP): Irbesartan / amlodipine, decision type: , therapeutic area: , PIP number: P/0245/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Tepotinib, decision type: , therapeutic area: , PIP number: P/0279/2018

Opinion/decision on a Paediatric investigation plan (PIP): Tepotinib, decision type: , therapeutic area: , PIP number: P/0279/2018

Opinion/decision on a Paediatric investigation plan (PIP): Tepotinib, decision type: , therapeutic area: , PIP number: P/0279/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ianalumab, decision type: , therapeutic area: , PIP number: P/0332/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ianalumab, decision type: , therapeutic area: , PIP number: P/0332/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ianalumab, decision type: , therapeutic area: , PIP number: P/0332/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3- zeta chimeric antigen receptor, decision type: , therapeutic area: , PIP number: P/0232/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3- zeta chimeric antigen receptor, decision type: , therapeutic area: , PIP number: P/0232/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3- zeta chimeric antigen receptor, decision type: , therapeutic area: , PIP number: P/0232/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ibalizumab, decision type: , therapeutic area: , PIP number: P/0271/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ibalizumab, decision type: , therapeutic area: , PIP number: P/0271/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ibalizumab, decision type: , therapeutic area: , PIP number: P/0271/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): His-Ser-Gln-Gly-Thr-Phe-Thr-Ser-Asp-Lys(γ-Glu-palmitoyl)-Ser-Glu-Tyr-Leu-Asp-Ser-Glu-Arg-Ala-Arg-Asp-Phe-Val-Ala-Trp-Leu-Glu-Ala-Gly-Gly-OH (MEDI0382), decision type: , therapeutic area: , PIP nu

Opinion/decision on a Paediatric investigation plan (PIP): His-Ser-Gln-Gly-Thr-Phe-Thr-Ser-Asp-Lys(γ-Glu-palmitoyl)-Ser-Glu-Tyr-Leu-Asp-Ser-Glu-Arg-Ala-Arg-Asp-Phe-Val-Ala-Trp-Leu-Glu-Ala-Gly-Gly-OH (MEDI0382), decision type: , therapeutic area: , PIP nu

Opinion/decision on a Paediatric investigation plan (PIP): His-Ser-Gln-Gly-Thr-Phe-Thr-Ser-Asp-Lys(γ-Glu-palmitoyl)-Ser-Glu-Tyr-Leu-Asp-Ser-Glu-Arg-Ala-Arg-Asp-Phe-Val-Ala-Trp-Leu-Glu-Ala-Gly-Gly-OH (MEDI0382), decision type: , therapeutic area: , PIP number: P/0235/2018

Europe - EMA - European Medicines Agency

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

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ferric pyrophosphate citrate, decision type: , therapeutic area: , PIP number: P/0263/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ferric pyrophosphate citrate, decision type: , therapeutic area: , PIP number: P/0263/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ferric pyrophosphate citrate, decision type: , therapeutic area: , PIP number: P/0263/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ivosidenib, decision type: , therapeutic area: , PIP number: P/0280/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ivosidenib, decision type: , therapeutic area: , PIP number: P/0280/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ivosidenib, decision type: , therapeutic area: , PIP number: P/0280/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): diphtheria toxin interleukin-3 Fusion Protein, decision type: , therapeutic area: , PIP number: P/0326/2018

Opinion/decision on a Paediatric investigation plan (PIP): diphtheria toxin interleukin-3 Fusion Protein, decision type: , therapeutic area: , PIP number: P/0326/2018

Opinion/decision on a Paediatric investigation plan (PIP): diphtheria toxin interleukin-3 Fusion Protein, decision type: , therapeutic area: , PIP number: P/0326/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): interferon beta-1a, decision type: , therapeutic area: , PIP number: P/0305/2018

Opinion/decision on a Paediatric investigation plan (PIP): interferon beta-1a, decision type: , therapeutic area: , PIP number: P/0305/2018

Opinion/decision on a Paediatric investigation plan (PIP): interferon beta-1a, decision type: , therapeutic area: , PIP number: P/0305/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140], decision type: , therapeutic area: , PIP number: P/0236/2018

Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140], decision type: , therapeutic area: , PIP number: P/0236/2018

Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140], decision type: , therapeutic area: , PIP number: P/0236/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647), decision type: , therapeutic area: , PIP number: P/0281/2018

Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647), decision type: , therapeutic area: , PIP number: P/0281/2018

Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647), decision type: , therapeutic area: , PIP number: P/0281/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, decision type: , therapeutic area: , PIP number: P/0282/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, decision type: , therapeutic area: , PIP number: P/0282/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, decision type: , therapeutic area: , PIP number: P/0282/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Lynparza,Olaparib, decision type: , therapeutic area: , PIP number: P/0262/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lynparza,Olaparib, decision type: , therapeutic area: , PIP number: P/0262/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lynparza,Olaparib, decision type: , therapeutic area: , PIP number: P/0262/2018

Europe - EMA - European Medicines Agency

17-1-2019

Supplier assessment, approval and qualification for listed and complementary medicines

Supplier assessment, approval and qualification for listed and complementary medicines

Updated to be consistent with PE009-13, the PIC/S Guide to GMP

Therapeutic Goods Administration - Australia

16-1-2019

Sampling and testing for listed and complementary medicines

Sampling and testing for listed and complementary medicines

Updated to be consistent with PE009-13, the PIC/S Guide to GMP

Therapeutic Goods Administration - Australia

16-1-2019

Product Quality Reviews (PQRs) for listed and complementary medicines

Product Quality Reviews (PQRs) for listed and complementary medicines

Updated to be consistent with PE009-13, the PIC/S Guide to GMP

Therapeutic Goods Administration - Australia

16-1-2019

Process validation for listed and complementary medicines

Process validation for listed and complementary medicines

Updated to be consistent with PE009-13, the PIC/S Guide to GMP

Therapeutic Goods Administration - Australia

15-1-2019

Ongoing stability testing for listed and complementary medicines

Ongoing stability testing for listed and complementary medicines

Updated to be consistent with PE009-13, the PIC/S Guide to GMP

Therapeutic Goods Administration - Australia

15-1-2019

Medicinal gases guidance

Medicinal gases guidance

Medicinal gases guidance has been updated to reflect expectations of the new PIC/S guide to GMP PE009-13

Therapeutic Goods Administration - Australia

14-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, decision type: , therapeutic area: , PIP number: P/0254/2018

Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, decision type: , therapeutic area: , PIP number: P/0254/2018

Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, decision type: , therapeutic area: , PIP number: P/0254/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Olumiant,baricitinib, decision type: , therapeutic area: , PIP number: P/0291/2018

Opinion/decision on a Paediatric investigation plan (PIP): Olumiant,baricitinib, decision type: , therapeutic area: , PIP number: P/0291/2018

Opinion/decision on a Paediatric investigation plan (PIP): Olumiant,baricitinib, decision type: , therapeutic area: , PIP number: P/0291/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Kevzara,sarilumab, decision type: , therapeutic area: , PIP number: P/0335/2018

Opinion/decision on a Paediatric investigation plan (PIP): Kevzara,sarilumab, decision type: , therapeutic area: , PIP number: P/0335/2018

Opinion/decision on a Paediatric investigation plan (PIP): Kevzara,sarilumab, decision type: , therapeutic area: , PIP number: P/0335/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, decision type: , therapeutic area: , PIP number: P/0338/2018

Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, decision type: , therapeutic area: , PIP number: P/0338/2018

Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, decision type: , therapeutic area: , PIP number: P/0338/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Adcetris,Brentuximab vedotin, decision type: , therapeutic area: , PIP number: P/0327/2018

Opinion/decision on a Paediatric investigation plan (PIP): Adcetris,Brentuximab vedotin, decision type: , therapeutic area: , PIP number: P/0327/2018

Opinion/decision on a Paediatric investigation plan (PIP): Adcetris,Brentuximab vedotin, decision type: , therapeutic area: , PIP number: P/0327/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Veliparib, decision type: , therapeutic area: , PIP number: P/0256/2018

Opinion/decision on a Paediatric investigation plan (PIP): Veliparib, decision type: , therapeutic area: , PIP number: P/0256/2018

Opinion/decision on a Paediatric investigation plan (PIP): Veliparib, decision type: , therapeutic area: , PIP number: P/0256/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): navitoclax, decision type: , therapeutic area: , PIP number: P/0255/2018

Opinion/decision on a Paediatric investigation plan (PIP): navitoclax, decision type: , therapeutic area: , PIP number: P/0255/2018

Opinion/decision on a Paediatric investigation plan (PIP): navitoclax, decision type: , therapeutic area: , PIP number: P/0255/2018

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Autologous skeletal myoblasts expanded ex vivo, Treatment of oculopharyngeal muscular dystrophy, 13/04/2018, Negative

Orphan designation: Autologous skeletal myoblasts expanded ex vivo, Treatment of oculopharyngeal muscular dystrophy, 13/04/2018, Negative

Orphan designation: Autologous skeletal myoblasts expanded ex vivo, Treatment of oculopharyngeal muscular dystrophy, 13/04/2018, Negative

Europe - EMA - European Medicines Agency

20-12-2018

TGA presentations: CAPSIG Seminar, 12 September 2018

TGA presentations: CAPSIG Seminar, 12 September 2018

Overview of regulatory requirements introduced as part of PIC/s PE009-13 Guide to GMP and a summary of the new PI041-1 Data Integrity

Therapeutic Goods Administration - Australia

19-12-2018


Opinion/decision on a Paediatric investigation plan (PIP): Abraxane,paclitaxel, decision type: , therapeutic area: , PIP number: P/0257/2018

Opinion/decision on a Paediatric investigation plan (PIP): Abraxane,paclitaxel, decision type: , therapeutic area: , PIP number: P/0257/2018

Opinion/decision on a Paediatric investigation plan (PIP): Abraxane,paclitaxel, decision type: , therapeutic area: , PIP number: P/0257/2018

Europe - EMA - European Medicines Agency

19-12-2018


Recommendations on eligibility to PRIME scheme -  Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Adcetris,brentuximab vedotin,  13/12/2018,  Positive

Summary of opinion: Adcetris,brentuximab vedotin, 13/12/2018, Positive

Summary of opinion: Adcetris,brentuximab vedotin, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Trecondi,treosulfan,  13/12/2018,  Positive

Summary of opinion: Trecondi,treosulfan, 13/12/2018, Positive

Summary of opinion: Trecondi,treosulfan, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

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

14-12-2018


Summary of opinion: Lusutrombopag Shionogi,lusutrombopag,  13/12/2018,  Positive

Summary of opinion: Lusutrombopag Shionogi,lusutrombopag, 13/12/2018, Positive

Summary of opinion: Lusutrombopag Shionogi,lusutrombopag, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Rapiscan,regadenoson,  13/12/2018,  Positive

Summary of opinion: Rapiscan,regadenoson, 13/12/2018, Positive

Summary of opinion: Rapiscan,regadenoson, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Miglustat Dipharma,miglustat,  13/12/2018,  Positive

Summary of opinion: Miglustat Dipharma,miglustat, 13/12/2018, Positive

Summary of opinion: Miglustat Dipharma,miglustat, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Tobramycin PARI,tobramycin,  13/12/2018,  Positive

Summary of opinion: Tobramycin PARI,tobramycin, 13/12/2018, Positive

Summary of opinion: Tobramycin PARI,tobramycin, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide,  13/12/2018,  Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Europe - EMA - European Medicines Agency