RIC.N.10 H.S CORONE POLICARBONATO

Informazioni principali

  • Nome commerciale:
  • RIC.N.10 H.S CORONE POLICARBONATO
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Dispositivo medico

Documenti

  • per il pubblico:
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  • per i professionisti:
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Localizzazione

  • Disponibile in:
  • RIC.N.10 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 and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

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

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

6-1-2019

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

FDA - U.S. Food and Drug Administration

4-1-2019

Olde York Potato Chips Issues Allergy Alert on Undeclared Milk in One Lot of Clancy's Wavy Potato Chips 10 Oz

Olde York Potato Chips Issues Allergy Alert on Undeclared Milk in One Lot of Clancy's Wavy Potato Chips 10 Oz

Olde York Potato Chips of Brampton, Ontario is recalling Clancy's Wavy Potato Chips 10 oz (UPC 0 41498 16306 8) with the specific lot code BEST If Used By FEB 22 19 1A6 because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. No other lot codes and no other products are involved in this action.

FDA - U.S. Food and Drug Administration

3-1-2019

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

FDA - U.S. Food and Drug Administration

21-12-2018

Funky Chunky, Llc Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 Oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts

Funky Chunky, Llc Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 Oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts

Funky Chunky, LLC of Eden Prairie, MN is recalling 10 oz Nutty Choco Pop Gift Box, 50 oz. Holiday Crowd Pleaser and 50 oz. Crowd Pleaser, because it may contain undeclared Almond and Cashew Tree Nut. People who have an allergy or severe sensitivity to Almonds and Cashews run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

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

Blokhuis stelt prioriteiten van actieprogramma Zwerfjongeren vast

Blokhuis stelt prioriteiten van actieprogramma Zwerfjongeren vast

Een betaalbare woonplek, voldoende kansen op een opleiding en een baan, financiële zelfredzaamheid en voldoende zorg en ondersteuning. Basisbehoeften voor ieder mens, maar waaraan de 10.700 zwerfjongeren (18 – 27 jaar) in Nederland nog te vaak tekortkomen. Op die vier ‘levensbrede’ prioriteiten zal de staatssecretaris zich richten met zijn actieprogramma Zwerfjongeren, dat hij afgelopen oktober in Tweede Kamer aankondigde. Met het actieprogramma brengt hij lokale partijen en gemeenten, maar ook andere ve...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-12-2018


Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

FDA - U.S. Food and Drug Administration

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

Europe - EMA - European Medicines Agency

10-12-2018


Agenda - CHMP agenda of the 10-13 December 2018

Agenda - CHMP agenda of the 10-13 December 2018

Agenda - CHMP agenda of the 10-13 December 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

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: 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

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 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


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment of maple syrup urine disease, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

4-1-2019


Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

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


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