Էպլերենոն

main_info

  • trade_name:
  • Էպլերենոն 25մգ դեղահատեր թաղանթապատ
  • dosage:
  • 25մգ(28/4x7/) բլիստերում
  • pharmaceutical_form:
  • դեղահատեր թաղանթապատ
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Էպլերենոն 25մգ դեղահատեր թաղանթապատ
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

  • source:
  • Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում - Armenia
  • last_update:
  • 31-05-2018

16-4-2019

Pest categorisation of Clavibacter sepedonicus

Pest categorisation of Clavibacter sepedonicus

Published on: Mon, 15 Apr 2019 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Clavibacter sepedonicus, a well‐defined and distinguishable bacterial plant pathogen of the family Microbacteriaceae. C. sepedonicus causes bacterial ring rot of potato and is reported from North America, Asia and Europe. The bacterium is mostly tuber transmitted, but it can also enter host plants through wounds or via contaminated equipment. C. sepedonicus i...

Europe - EFSA - European Food Safety Authority EFSA Journal

11-4-2019

Toxicity reference values (TRVs)

Toxicity reference values (TRVs)

As part of its missions and under the French National Environmental & Health Action Plan (2004-2008), the Agency began a national programme on TRVs in 2004 with the aim of building solid French expertise that could be shared by the various competent authorities in this area.

France - Agence Nationale du Médicament Vétérinaire

11-4-2019

Evaluation of confirmatory data following the Article 12 MRL review for dimethenamid‐P

Evaluation of confirmatory data following the Article 12 MRL review for dimethenamid‐P

Published on: Wed, 10 Apr 2019 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethenamid‐P in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap refers to the submission of a plant metabolism study investigating the fate of dimethenamid‐P following foliar treatment with a short preharvest interval (PHI) in a leafy or bu...

Europe - EFSA - European Food Safety Authority EFSA Journal

6-4-2019

Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)

Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)

Published on: Fri, 05 Apr 2019 Maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 (six‐event stack maize) was produced by conventional crossing to combine six single events: Bt11, MIR162, MIR604, 1507, 5307 and GA21. The GMO Panel previously assessed the six single events and 22 of their combinations and did not identify safety concerns. No new data on the maize single events or their 22 combinations that could lead to modification of the original conclusions on their safety have been identified. The mol...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-4-2019

Pest survey card on Synchytrium endobioticum

Pest survey card on Synchytrium endobioticum

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

Europe - EFSA - European Food Safety Authority EFSA Journal

4-4-2019

Pest survey card on Xanthomonas citri pv. citri and pv. aurantifolii

Pest survey card on Xanthomonas citri pv. citri and pv. aurantifolii

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

Europe - EFSA - European Food Safety Authority EFSA Journal

4-4-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

4-4-2019

Pest survey card on Huanglongbing and its vectors

Pest survey card on Huanglongbing and its vectors

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

Europe - EFSA - European Food Safety Authority EFSA Journal

28-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule

FDA announced several new actions as part of our commitment to ensure sound regulatory oversight of tobacco products and an effective application review process that considers the impact on public health.

FDA - U.S. Food and Drug Administration

25-3-2019

Plan voor beter passende zorg voor kwetsbare jongeren

Plan voor beter passende zorg voor kwetsbare jongeren

De best passende zorg voor de kwetsbare jongeren. Dat is het doel van het gezamenlijk actieplan dat de Branches Gespecialiseerde Zorg voor Jeugd (BGZJ) en het ministerie van VWS vandaag bekend maken. In het plan staan maatregelen om de huidige JeugdzorgPlus (gesloten jeugdhulp) te verbeteren. Zo moeten gedwongen afzonderingen tot het verleden behoren, het aantal suïcides omlaag en moeten het aantal gesloten plaatsingen en onnodige doorplaatsingen worden verminderd. Dat wordt gerealiseerd door betere onde...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-3-2019

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance pyridaben in tomatoes and aubergines. An MRL proposal of 0.15 mg/kg was derived for tomatoes and aubergines which reflects the intended use of the plant protection product containing pyridaben. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the FPS Health, Food chain safety and Environment of Belgium, submitted an application to modify the existing maximum residue level (MRL) for the active substance cyprodinil in Florence fennel to accommodate the intended use in the northern Europe. The submitted data were found sufficient to derive an MRL proposal of 4 mg/kg for cyprodinil in Florence fennel. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-3-2019

ANSES and University of Rennes 1 strengthen their scientific cooperation dedicated to "One Health"

ANSES and University of Rennes 1 strengthen their scientific cooperation dedicated to "One Health"

Roger Genet, Director General of ANSES, and David Alis, President of the University of Rennes 1, today signed a scientific framework agreement aimed at strengthening their cooperation on environmental health, focused primarily on the "One Health" concept covering human, animal and plant health for the benefit of all. To mark this occasion, a conference and round table were organised on the theme of the exposome, one of the key issues at the heart of this new partnership between the two institutions.  

France - Agence Nationale du Médicament Vétérinaire

15-3-2019

Peer review of the pesticide risk assessment of the active substance thiacloprid

Peer review of the pesticide risk assessment of the active substance thiacloprid

Published on: Thu, 14 Mar 2019 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance thiacloprid are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of thiaclopr...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Pest categorisation of Phymatotrichopsis omnivora

Pest categorisation of Phymatotrichopsis omnivora

Published on: Tue, 12 Mar 2019 The Panel on Plant Health performed a pest categorisation of Phymatotrichopsis omnivora, the causal agent of Phymatotrichum root rot of more than 2,000 dicotyledonous plant species, for the EU. The pest is listed as Trechispora brinkmannii in Annex IAI of Directive 2000/29/EC. P. omnivora is a well‐defined fungal species and reliable methods exist for its detection and identification. It is present in south‐western USA, northern Mexico, Libya and Venezuela. The pest is not...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-3-2019

Phytophthora ramorum: monitor its spread and eradicate contaminated sites

Phytophthora ramorum: monitor its spread and eradicate contaminated sites

First detected in France in the Finistère region in May 2017, the plant pathogen Phytophthora ramorum poses a significant risk for many ornamental and forest-growing plants (rhododendrons, vibernum and larch trees). ANSES issues recommendations to monitor the spread of this fungus-like microorganism, prevent the risk of its introduction and eradicate outbreaks where it is already found.

France - Agence Nationale du Médicament Vétérinaire

7-3-2019

Pest survey card on Popillia japonica

Pest survey card on Popillia japonica

Published on: Wed, 06 Mar 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan

Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan

Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan.

FDA - U.S. Food and Drug Administration

16-4-2019

The companies will have 10 days to submit their plans to withdraw these products from the market to the #FDA.  #MedicalDevice

The companies will have 10 days to submit their plans to withdraw these products from the market to the #FDA. #MedicalDevice

The companies will have 10 days to submit their plans to withdraw these products from the market to the #FDA. #MedicalDevice

FDA - U.S. Food and Drug Administration

16-4-2019


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

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

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

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rapiscan,regadenoson, decision type: , therapeutic area: , PIP number: P/0030/2019

Opinion/decision on a Paediatric investigation plan (PIP): Rapiscan,regadenoson, decision type: , therapeutic area: , PIP number: P/0030/2019

Opinion/decision on a Paediatric investigation plan (PIP): Rapiscan,regadenoson, decision type: , therapeutic area: , PIP number: P/0030/2019

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Vimpat,lacosamide, decision type: , therapeutic area: , PIP number: P/0059/2019

Opinion/decision on a Paediatric investigation plan (PIP): Vimpat,lacosamide, decision type: , therapeutic area: , PIP number: P/0059/2019

Opinion/decision on a Paediatric investigation plan (PIP): Vimpat,lacosamide, decision type: , therapeutic area: , PIP number: P/0059/2019

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Tivicay,dolutegravir, decision type: , therapeutic area: , PIP number: P/0017/2019

Opinion/decision on a Paediatric investigation plan (PIP): Tivicay,dolutegravir, decision type: , therapeutic area: , PIP number: P/0017/2019

Opinion/decision on a Paediatric investigation plan (PIP): Tivicay,dolutegravir, decision type: , therapeutic area: , PIP number: P/0017/2019

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Revatio,sildenafil, decision type: , therapeutic area: , PIP number: P/0016/2019

Opinion/decision on a Paediatric investigation plan (PIP): Revatio,sildenafil, decision type: , therapeutic area: , PIP number: P/0016/2019

Opinion/decision on a Paediatric investigation plan (PIP): Revatio,sildenafil, decision type: , therapeutic area: , PIP number: P/0016/2019

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): ocrelizumab, decision type: , therapeutic area: , PIP number: P/0028/2019

Opinion/decision on a Paediatric investigation plan (PIP): ocrelizumab, decision type: , therapeutic area: , PIP number: P/0028/2019

Opinion/decision on a Paediatric investigation plan (PIP): ocrelizumab, decision type: , therapeutic area: , PIP number: P/0028/2019

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Edarbi,Azilsartan medoxomil, decision type: , therapeutic area: , PIP number: P/0034/2019

Opinion/decision on a Paediatric investigation plan (PIP): Edarbi,Azilsartan medoxomil, decision type: , therapeutic area: , PIP number: P/0034/2019

Opinion/decision on a Paediatric investigation plan (PIP): Edarbi,Azilsartan medoxomil, decision type: , therapeutic area: , PIP number: P/0034/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Etripamil, decision type: , therapeutic area: , PIP number: P/0042/2019

Opinion/decision on a Paediatric investigation plan (PIP): Etripamil, decision type: , therapeutic area: , PIP number: P/0042/2019

Opinion/decision on a Paediatric investigation plan (PIP): Etripamil, decision type: , therapeutic area: , PIP number: P/0042/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine,meloxicam (HTX-011), decision type: , therapeutic area: , PIP number: P/0013/2019

Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine,meloxicam (HTX-011), decision type: , therapeutic area: , PIP number: P/0013/2019

Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine,meloxicam (HTX-011), decision type: , therapeutic area: , PIP number: P/0013/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ibrance,palbociclib, decision type: , therapeutic area: , PIP number: P/0005/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ibrance,palbociclib, decision type: , therapeutic area: , PIP number: P/0005/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ibrance,palbociclib, decision type: , therapeutic area: , PIP number: P/0005/2019

Europe - EMA - European Medicines Agency

12-4-2019

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

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

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

Europe -DG Health and Food Safety

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Pretomanid, decision type: , therapeutic area: , PIP number: P/0058/2019

Opinion/decision on a Paediatric investigation plan (PIP): Pretomanid, decision type: , therapeutic area: , PIP number: P/0058/2019

Opinion/decision on a Paediatric investigation plan (PIP): Pretomanid, decision type: , therapeutic area: , PIP number: P/0058/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Givosiran, decision type: , therapeutic area: , PIP number: P/0038/2019

Opinion/decision on a Paediatric investigation plan (PIP): Givosiran, decision type: , therapeutic area: , PIP number: P/0038/2019

Opinion/decision on a Paediatric investigation plan (PIP): Givosiran, decision type: , therapeutic area: , PIP number: P/0038/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Pexidartinib, decision type: , therapeutic area: , PIP number: P/0044/2019

Opinion/decision on a Paediatric investigation plan (PIP): Pexidartinib, decision type: , therapeutic area: , PIP number: P/0044/2019

Opinion/decision on a Paediatric investigation plan (PIP): Pexidartinib, decision type: , therapeutic area: , PIP number: P/0044/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ozanimod, decision type: , therapeutic area: , PIP number: P/0050/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ozanimod, decision type: , therapeutic area: , PIP number: P/0050/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ozanimod, decision type: , therapeutic area: , PIP number: P/0050/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, decision type: , therapeutic area: , PIP number: P/0045/2019

Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, decision type: , therapeutic area: , PIP number: P/0045/2019

Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, decision type: , therapeutic area: , PIP number: P/0045/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Dienogest,ethinyl estradiol (LPRI-424), decision type: , therapeutic area: , PIP number: P/0053/2019

Opinion/decision on a Paediatric investigation plan (PIP): Dienogest,ethinyl estradiol (LPRI-424), decision type: , therapeutic area: , PIP number: P/0053/2019

Opinion/decision on a Paediatric investigation plan (PIP): Dienogest,ethinyl estradiol (LPRI-424), decision type: , therapeutic area: , PIP number: P/0053/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Crizanlizumab, decision type: , therapeutic area: , PIP number: P/0060/2019

Opinion/decision on a Paediatric investigation plan (PIP): Crizanlizumab, decision type: , therapeutic area: , PIP number: P/0060/2019

Opinion/decision on a Paediatric investigation plan (PIP): Crizanlizumab, decision type: , therapeutic area: , PIP number: P/0060/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Braftovi,Encorafenib, decision type: , therapeutic area: , PIP number: P/0049/2019

Opinion/decision on a Paediatric investigation plan (PIP): Braftovi,Encorafenib, decision type: , therapeutic area: , PIP number: P/0049/2019

Opinion/decision on a Paediatric investigation plan (PIP): Braftovi,Encorafenib, decision type: , therapeutic area: , PIP number: P/0049/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Tremfya,guselkumab, decision type: , therapeutic area: , PIP number: P/0025/2019

Opinion/decision on a Paediatric investigation plan (PIP): Tremfya,guselkumab, decision type: , therapeutic area: , PIP number: P/0025/2019

Opinion/decision on a Paediatric investigation plan (PIP): Tremfya,guselkumab, decision type: , therapeutic area: , PIP number: P/0025/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Mektovi,binimetinib, decision type: , therapeutic area: , PIP number: P/0037/2019

Opinion/decision on a Paediatric investigation plan (PIP): Mektovi,binimetinib, decision type: , therapeutic area: , PIP number: P/0037/2019

Opinion/decision on a Paediatric investigation plan (PIP): Mektovi,binimetinib, decision type: , therapeutic area: , PIP number: P/0037/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica,Ibrutinib, decision type: , therapeutic area: , PIP number: P/0021/2019

Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica,Ibrutinib, decision type: , therapeutic area: , PIP number: P/0021/2019

Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica,Ibrutinib, decision type: , therapeutic area: , PIP number: P/0021/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): semaglutide, decision type: , therapeutic area: , PIP number: P/0007/2019

Opinion/decision on a Paediatric investigation plan (PIP): semaglutide, decision type: , therapeutic area: , PIP number: P/0007/2019

Opinion/decision on a Paediatric investigation plan (PIP): semaglutide, decision type: , therapeutic area: , PIP number: P/0007/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Turoctocog alfa pegol, decision type: , therapeutic area: , PIP number: P/0046/2019

Opinion/decision on a Paediatric investigation plan (PIP): Turoctocog alfa pegol, decision type: , therapeutic area: , PIP number: P/0046/2019

Opinion/decision on a Paediatric investigation plan (PIP): Turoctocog alfa pegol, decision type: , therapeutic area: , PIP number: P/0046/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, decision type: , therapeutic area: , PIP number: P/0009/2019

Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, decision type: , therapeutic area: , PIP number: P/0009/2019

Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, decision type: , therapeutic area: , PIP number: P/0009/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Edurant,rilpivirine, decision type: , therapeutic area: , PIP number: P/0039/2019

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,rilpivirine, decision type: , therapeutic area: , PIP number: P/0039/2019

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,rilpivirine, decision type: , therapeutic area: , PIP number: P/0039/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ozempic,semaglutide, decision type: , therapeutic area: , PIP number: P/0036/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ozempic,semaglutide, decision type: , therapeutic area: , PIP number: P/0036/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ozempic,semaglutide, decision type: , therapeutic area: , PIP number: P/0036/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta,darunavir,cobicistat, decision type: , therapeutic area: , PIP number: P/0006/2019

Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta,darunavir,cobicistat, decision type: , therapeutic area: , PIP number: P/0006/2019

Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta,darunavir,cobicistat, decision type: , therapeutic area: , PIP number: P/0006/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Triumeq,dolutegravir,abacavir,lamivudine, decision type: , therapeutic area: , PIP number: P/0018/2019

Opinion/decision on a Paediatric investigation plan (PIP): Triumeq,dolutegravir,abacavir,lamivudine, decision type: , therapeutic area: , PIP number: P/0018/2019

Opinion/decision on a Paediatric investigation plan (PIP): Triumeq,dolutegravir,abacavir,lamivudine, decision type: , therapeutic area: , PIP number: P/0018/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Moventig,Naloxegol, decision type: , therapeutic area: , PIP number: P/0056/2019

Opinion/decision on a Paediatric investigation plan (PIP): Moventig,Naloxegol, decision type: , therapeutic area: , PIP number: P/0056/2019

Opinion/decision on a Paediatric investigation plan (PIP): Moventig,Naloxegol, decision type: , therapeutic area: , PIP number: P/0056/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sodium sulphate,potassium sulphate,magnesium sulphate heptahydrate (BLI800), decision type: , therapeutic area: , PIP number: P/0035/2019

Opinion/decision on a Paediatric investigation plan (PIP): Sodium sulphate,potassium sulphate,magnesium sulphate heptahydrate (BLI800), decision type: , therapeutic area: , PIP number: P/0035/2019

Opinion/decision on a Paediatric investigation plan (PIP): Sodium sulphate,potassium sulphate,magnesium sulphate heptahydrate (BLI800), decision type: , therapeutic area: , PIP number: P/0035/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Birch pollen extract, decision type: , therapeutic area: , PIP number: P/0029/2019

Opinion/decision on a Paediatric investigation plan (PIP): Birch pollen extract, decision type: , therapeutic area: , PIP number: P/0029/2019

Opinion/decision on a Paediatric investigation plan (PIP): Birch pollen extract, decision type: , therapeutic area: , PIP number: P/0029/2019

Europe - EMA - European Medicines Agency

9-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Entrectinib, decision type: , therapeutic area: , PIP number: P/0010/2019

Opinion/decision on a Paediatric investigation plan (PIP): Entrectinib, decision type: , therapeutic area: , PIP number: P/0010/2019

Opinion/decision on a Paediatric investigation plan (PIP): Entrectinib, decision type: , therapeutic area: , PIP number: P/0010/2019

Europe - EMA - European Medicines Agency

9-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto,Venetoclax, decision type: , therapeutic area: , PIP number: P/0001/2019

Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto,Venetoclax, decision type: , therapeutic area: , PIP number: P/0001/2019

Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto,Venetoclax, decision type: , therapeutic area: , PIP number: P/0001/2019

Europe - EMA - European Medicines Agency

8-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): axicabtagene ciloleucel, decision type: , therapeutic area: , PIP number: P/0004/2019

Opinion/decision on a Paediatric investigation plan (PIP): axicabtagene ciloleucel, decision type: , therapeutic area: , PIP number: P/0004/2019

Opinion/decision on a Paediatric investigation plan (PIP): axicabtagene ciloleucel, decision type: , therapeutic area: , PIP number: P/0004/2019

Europe - EMA - European Medicines Agency

8-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Pimodivir, decision type: , therapeutic area: , PIP number: P/0003/2019

Opinion/decision on a Paediatric investigation plan (PIP): Pimodivir, decision type: , therapeutic area: , PIP number: P/0003/2019

Opinion/decision on a Paediatric investigation plan (PIP): Pimodivir, decision type: , therapeutic area: , PIP number: P/0003/2019

Europe - EMA - European Medicines Agency

8-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Gadopiclenol, decision type: , therapeutic area: , PIP number: P/0055/2019

Opinion/decision on a Paediatric investigation plan (PIP): Gadopiclenol, decision type: , therapeutic area: , PIP number: P/0055/2019

Opinion/decision on a Paediatric investigation plan (PIP): Gadopiclenol, decision type: , therapeutic area: , PIP number: P/0055/2019

Europe - EMA - European Medicines Agency

4-4-2019

Dr. Gottlieb has been committed to showing how our proposed approach would help get #DigitalHealth tech to mkt more efficiently, encouraging more developers to move into the health space & fulfill the aims of our #DigitalHealth Innovation Action Plan:  ht

Dr. Gottlieb has been committed to showing how our proposed approach would help get #DigitalHealth tech to mkt more efficiently, encouraging more developers to move into the health space & fulfill the aims of our #DigitalHealth Innovation Action Plan: ht

Dr. Gottlieb has been committed to showing how our proposed approach would help get #DigitalHealth tech to mkt more efficiently, encouraging more developers to move into the health space & fulfill the aims of our #DigitalHealth Innovation Action Plan: https://go.usa.gov/xmcF4 . pic.twitter.com/fAfZsnjsV4

FDA - U.S. Food and Drug Administration

4-4-2019

As FDA Commissioner, Dr. Gottlieb routinely played an integral role in unveiling newly-approved #MedicalDevices and the FDA’s plans to foster innovation and regulate #DigitalHealth technologies safely.pic.twitter.com/JX8Mi7up9t

As FDA Commissioner, Dr. Gottlieb routinely played an integral role in unveiling newly-approved #MedicalDevices and the FDA’s plans to foster innovation and regulate #DigitalHealth technologies safely.pic.twitter.com/JX8Mi7up9t

As FDA Commissioner, Dr. Gottlieb routinely played an integral role in unveiling newly-approved #MedicalDevices and the FDA’s plans to foster innovation and regulate #DigitalHealth technologies safely. pic.twitter.com/JX8Mi7up9t

FDA - U.S. Food and Drug Administration

4-4-2019

The Medical Device Safety Action Plan, outlining the vision for continuing to ensure safe and effective medical devices, was an #FDA initiative the Commissioner worked closely with CDRH to promote.  https://go.usa.gov/xmcFK pic.twitter.com/1mYmn1tMf9

The Medical Device Safety Action Plan, outlining the vision for continuing to ensure safe and effective medical devices, was an #FDA initiative the Commissioner worked closely with CDRH to promote. https://go.usa.gov/xmcFK pic.twitter.com/1mYmn1tMf9

The Medical Device Safety Action Plan, outlining the vision for continuing to ensure safe and effective medical devices, was an #FDA initiative the Commissioner worked closely with CDRH to promote. https://go.usa.gov/xmcFK  pic.twitter.com/1mYmn1tMf9

FDA - U.S. Food and Drug Administration

3-4-2019

An Action Plan for Medical Devices

An Action Plan for Medical Devices

The Action Plan will further improve Australia’s medical device regulatory system and place patient safety first

Therapeutic Goods Administration - Australia

29-3-2019

Risk management plans for medicines and biologicals

Risk management plans for medicines and biologicals

Risk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form

Therapeutic Goods Administration - Australia

25-3-2019


Pharmacovigilance Risk Assessment Committee (PRAC): Work Plan 2019

Pharmacovigilance Risk Assessment Committee (PRAC): Work Plan 2019

Pharmacovigilance Risk Assessment Committee (PRAC): Work Plan 2019

Europe - EMA - European Medicines Agency

21-3-2019

The #FDA expects significant attendance from the public and advises attendees to plan appropriately. We recommend that you arrive early to avoid long lines and inconveniences. #FDA #MedicalDevice

The #FDA expects significant attendance from the public and advises attendees to plan appropriately. We recommend that you arrive early to avoid long lines and inconveniences. #FDA #MedicalDevice

The #FDA expects significant attendance from the public and advises attendees to plan appropriately. We recommend that you arrive early to avoid long lines and inconveniences. #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

8-3-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline, decision type: , therapeutic area: , PIP number: P/87/2009

Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline, decision type: , therapeutic area: , PIP number: P/87/2009

Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline, decision type: , therapeutic area: , PIP number: P/87/2009

Europe - EMA - European Medicines Agency