ADTEC MANICO PINZA MONOUSO PRES.ATR.D:5/31

Informazioni principali

  • Nome commerciale:
  • ADTEC MANICO PINZA MONOUSO PRES.ATR.D:5/31
  • 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:
  • ADTEC MANICO PINZA MONOUSO PRES.ATR.D:5/31
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • PINZE MONOUSO PER CHIRURGIA MINI-INVASIVA

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • S
  • Data dell'autorizzazione:
  • 20-11-2009
  • 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.

18-1-2019

Data sources on animal diseases: Country Card of Greece

Data sources on animal diseases: Country Card of Greece

Published on: Wed, 16 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Austria

Data sources on animal diseases: Country Card of Austria

Published on: Wed, 16 Jan 2019 Mapping the ‘data sources’ on animal diseases, in each European Union (EU) Member State, is one of the activities of EFSA 's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresp...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Cyprus

Data sources on animal diseases: Country Card of Cyprus

Published on: Wed, 16 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Bulgaria

Data sources on animal diseases: Country Card of Bulgaria

Published on: Wed, 16 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State, is one of the activities of EFSA 's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspo...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Kabinetsdelegatie naar World Economic Forum in Davos

Kabinetsdelegatie naar World Economic Forum in Davos

Minister-president Rutte neemt woensdag 23 en donderdag 24 januari deel aan het World Economic Forum (WEF) in het Zwitserse Davos. Ook minister Kaag voor Buitenlandse Handel en Ontwikkelingssamenwerking, minister Hoekstra van Financiën, minister Bruins voor Medische Zorg en Sport, minister Cora van Nieuwenhuizen en staatssecretaris Van Veldhoven, beiden van Infrastructuur en Waterstaat, reizen af naar Davos.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-1-2019

Outcome of the public consultation on the draft statement on genotoxicity assessment of chemical mixtures

Outcome of the public consultation on the draft statement on genotoxicity assessment of chemical mixtures

Published on: Wed, 16 Jan 2019 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the genotoxicity assessment of chemical mixtures. The draft statement was prepared by a dedicated working group of the Scientific Committee and endorsed by the Scientific Committee for public consultation at its 89th plenary meeting of 28‐29 May 2018. The public consultation for this document was open from 26 June until 9 ...

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

Antimicrobial resistance

Antimicrobial resistance

Antimicrobial resistance is a major international human and animal health issue, because the emergence and spread of drug-resistant strains of bacteria call into question the efficacy of these treatments in humans and animals alike. Preserving the effectiveness of antibiotics is therefore a genuine public health challenge requiring an integrated approach across all types of medicine, according to the "One Health" concept covering both humans and animals. ANSES has mobilised significant resources to addr...

France - Agence Nationale du Médicament Vétérinaire

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

20-12-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

The FDA provides update on Essure postmarket review study as company prepares to halt sales of the device on December 31.

FDA - U.S. Food and Drug Administration

20-12-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for mesotrione in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for mesotrione in light of confirmatory data

Published on: Wed, 19 Dec 2018 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applican...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in France and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in France and EFSA – Final report

Published on: Tue, 11 Dec 2018 The main goal of the Framework Partnership Agreement project is to put in place a relevant organisation in order to improve gathering, checking, storage and providing of data from national monitoring programs to EFSA. By accepting to participate in the pilot project, France has committed to implement several enhancement actions on the overall system of data collection and submission. This report describes the results of the implementations of these measures and presents th...

Europe - EFSA - European Food Safety Authority Publications

9-12-2018

TachoSil

TachoSil

Product approval information is indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery, when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.

FDA - U.S. Food and Drug Administration

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

4-12-2018


European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

Europe - EMA - European Medicines Agency

3-12-2018

November 28, 2018: Former Vice President of Insys Pharmaceuticals Pleads Guilty to Racketeering Scheme

November 28, 2018: Former Vice President of Insys Pharmaceuticals Pleads Guilty to Racketeering Scheme

November 28, 2018: Former Vice President of Insys Pharmaceuticals Pleads Guilty to Racketeering Scheme

FDA - U.S. Food and Drug Administration

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

28-11-2018

ANSES provides access to the data from its study on dietary exposure of children under three years of age to chemicals

ANSES provides access to the data from its study on dietary exposure of children under three years of age to chemicals

ANSES is publishing all the data from its Infant Total Diet Study (iTDS). Available as OpenData on the official website data.gouv.fr, this document presents all the data on concentrations of chemical residues or contaminants in the diet of children under three years of age. "Total Diet Studies" (TDS) are national surveys that aim to estimate people's exposure to chemical contaminants in food. They rely on the analysis of a large number of substances in food samples that reflect consumption by the popula...

France - Agence Nationale du Médicament Vétérinaire

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

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

18-12-2018

Alkyl nitrites - public meetings

Alkyl nitrites - public meetings

The TGA will be co-hosting two public meetings regarding appropriate access and safety controls of alkyl nitrites: Sydney 31 Jan 2019 and Melbourne 7 Feb 2019

Therapeutic Goods Administration - Australia

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

30-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, decision type: , therapeutic area: , PIP number: P/0230/2018

Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, decision type: , therapeutic area: , PIP number: P/0230/2018

Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, decision type: , therapeutic area: , PIP number: P/0230/2018

Europe - EMA - European Medicines Agency

30-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, decision type: , therapeutic area: , PIP number: P/0231/2018

Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, decision type: , therapeutic area: , PIP number: P/0231/2018

Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, decision type: , therapeutic area: , PIP number: P/0231/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Emapalumab, decision type: , therapeutic area: , PIP number: P/0152/2018

Opinion/decision on a Paediatric investigation plan (PIP): Emapalumab, decision type: , therapeutic area: , PIP number: P/0152/2018

Opinion/decision on a Paediatric investigation plan (PIP): Emapalumab, decision type: , therapeutic area: , PIP number: P/0152/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): lamivudine,dolutegravir, decision type: , therapeutic area: , PIP number: P/0151/2018

Opinion/decision on a Paediatric investigation plan (PIP): lamivudine,dolutegravir, decision type: , therapeutic area: , PIP number: P/0151/2018

Opinion/decision on a Paediatric investigation plan (PIP): lamivudine,dolutegravir, decision type: , therapeutic area: , PIP number: P/0151/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Larotrectinib, decision type: , therapeutic area: , PIP number: P/0182/2018

Opinion/decision on a Paediatric investigation plan (PIP): Larotrectinib, decision type: , therapeutic area: , PIP number: P/0182/2018

Opinion/decision on a Paediatric investigation plan (PIP): Larotrectinib, decision type: , therapeutic area: , PIP number: P/0182/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Rimiducid, decision type: , therapeutic area: , PIP number: P/0186/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rimiducid, decision type: , therapeutic area: , PIP number: P/0186/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rimiducid, decision type: , therapeutic area: , PIP number: P/0186/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): gabapentin, decision type: , therapeutic area: , PIP number: P/0198/2018

Opinion/decision on a Paediatric investigation plan (PIP): gabapentin, decision type: , therapeutic area: , PIP number: P/0198/2018

Opinion/decision on a Paediatric investigation plan (PIP): gabapentin, decision type: , therapeutic area: , PIP number: P/0198/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Zavicefta,Ceftazidime,avibactam, decision type: , therapeutic area: , PIP number: P/0149/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zavicefta,Ceftazidime,avibactam, decision type: , therapeutic area: , PIP number: P/0149/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zavicefta,Ceftazidime,avibactam, decision type: , therapeutic area: , PIP number: P/0149/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Sovaldi,Sofosbuvir, decision type: , therapeutic area: , PIP number: P/0172/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sovaldi,Sofosbuvir, decision type: , therapeutic area: , PIP number: P/0172/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sovaldi,Sofosbuvir, decision type: , therapeutic area: , PIP number: P/0172/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Spherox,spheroids of human autologous matrix-associated chondrocytes, decision type: , therapeutic area: , PIP number: P/0161/2018

Opinion/decision on a Paediatric investigation plan (PIP): Spherox,spheroids of human autologous matrix-associated chondrocytes, decision type: , therapeutic area: , PIP number: P/0161/2018

Opinion/decision on a Paediatric investigation plan (PIP): Spherox,spheroids of human autologous matrix-associated chondrocytes, decision type: , therapeutic area: , PIP number: P/0161/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Zinforo,Ceftaroline fosamil, decision type: , therapeutic area: , PIP number: P/0176/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zinforo,Ceftaroline fosamil, decision type: , therapeutic area: , PIP number: P/0176/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zinforo,Ceftaroline fosamil, decision type: , therapeutic area: , PIP number: P/0176/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Otezla,apremilast, decision type: , therapeutic area: , PIP number: P/0163/2018

Opinion/decision on a Paediatric investigation plan (PIP): Otezla,apremilast, decision type: , therapeutic area: , PIP number: P/0163/2018

Opinion/decision on a Paediatric investigation plan (PIP): Otezla,apremilast, decision type: , therapeutic area: , PIP number: P/0163/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri,pixantrone (dimaleate), decision type: , therapeutic area: , PIP number: P/0227/2018

Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri,pixantrone (dimaleate), decision type: , therapeutic area: , PIP number: P/0227/2018

Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri,pixantrone (dimaleate), decision type: , therapeutic area: , PIP number: P/0227/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate,formoterol fumarate dihydrate, decision type: , therapeutic area: , PIP number: P/0159/2018

Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate,formoterol fumarate dihydrate, decision type: , therapeutic area: , PIP number: P/0159/2018

Opinion/decision on a Paediatric investigation plan (PIP): Beclometasone dipropionate,formoterol fumarate dihydrate, decision type: , therapeutic area: , PIP number: P/0159/2018

Europe - EMA - European Medicines Agency