Կուրոսուրֆ

main_info

  • trade_name:
  • Կուրոսուրֆ
  • dosage:
  • 80մգ/մլ1.5մլ ապակե սրվակ
  • pharmaceutical_form:
  • դեղակախույթ ներշնչափողային
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Կուրոսուրֆ
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

18-4-2019

Systematic review on health outcomes related to the age of introduction of complementary food

Systematic review on health outcomes related to the age of introduction of complementary food

Published on: Wed, 17 Apr 2019 In 2016, the European Commission gave EFSA a mandate to update its 2009 opinion on the appropriate age for introduction of complementary feeding of infants. In order to retrieve data on health outcomes related to the age of introduction of complementary food, a systematic literature review will be conducted by EFSA. This report presents the preparatory work that is performed by Pallas, with advice of Wageningen University, for the systematic literature review. It provides ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-4-2019

Enforcement Report for the Week of April 17, 2019

Enforcement Report for the Week of April 17, 2019

Recently Updated Records for the Week of April 17, 2019 Last Modified Date: Tuesday, April 16, 2019

FDA - U.S. Food and Drug Administration

15-4-2019

Enforcement Report for the Week of May 24, 2017

Enforcement Report for the Week of May 24, 2017

Recently Updated Records for the Week of May 24, 2017 Last Modified Date: Monday, April 15, 2019

FDA - U.S. Food and Drug Administration

12-4-2019

Outcome of a public consultation on the draft scientific opinion on the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels

Outcome of a public consultation on the draft scientific opinion on the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels

Published on: Thu, 11 Apr 2019 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the interested parties on a draft scientific opinion on the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels prepared by the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel), supported by the Working Group on hydrocyanic acid in food. The draft opinion was endorsed by the CONTAM Panel for public consultation at it...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-4-2019

Report on suspected side effects reported for medicinal cannabis

Report on suspected side effects reported for medicinal cannabis

Dizziness, nausea and concentration problems are some of the suspected side effects that have been reported to the Danish Medicines Agency in the first year of the medicinal cannabis pilot programme.

Danish Medicines Agency

10-4-2019

Outcome of the public consultation on the draft administrative guidance on the preparation and presentation of applications for authorisation of additives for use in animal nutrition

Outcome of the public consultation on the draft administrative guidance on the preparation and presentation of applications for authorisation of additives for use in animal nutrition

Published on: Tue, 09 Apr 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 draft administrative guidance on the preparation and presentation of applications for authorisation of additives for use in animal nutrition (update 2019) prepared by the EFSA Applications Desk Unit to support applicants in preparing applications for authorisation of feed additive. The written public consultation for t...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-4-2019

Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances

Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances

Published on: Mon, 08 Apr 2019 This document provides guidance to applicants submitting dossiers for approval of pesticide active substances, and to Member States preparing assessment reports on active substances within the scope of Regulation (EC) No 1107/2009 and Commission Implementing Regulation (EU) No 844/2012 and its subsequent amendments. It describes the administrative requirements for the preparation and submission of the dossier to support an application for the approval, the amendment of ap...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-4-2019

Enforcement Report for the Week of April 03, 2019

Enforcement Report for the Week of April 03, 2019

Recently Updated Records for the Week of April 03, 2019 Last Modified Date: Monday, April 08, 2019

FDA - U.S. Food and Drug Administration

6-4-2019

Outcome of the public consultation on the draft guidance on the assessment of the safety of feed additives for the environment

Outcome of the public consultation on the draft guidance on the assessment of the safety of feed additives for the environment

Published on: Fri, 05 Apr 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 draft guidance on the assessment of the safety of feed additives for the environment prepared by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and endorsed by the Panel for public consultation at its Plenary meeting on 2 October 2018. The written public consultation for this docume...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-4-2019

Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorisation and annual post‐market environmental monitoring reports on GMOs authorised in the EU market

Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorisation and annual post‐market environmental monitoring reports on GMOs authorised in the EU market

Published on: Thu, 04 Apr 2019 Guidance of the Panel on Genetically Modified Organisms (GMOs) of the European Food Safety Authority (EFSA) assists applicants in the preparation and presentation of their market registration applications by describing elements and information/data requirements for the risk assessment and monitoring of GMOs. This explanatory note to the guidance: (1) clarifies the scope and methodology for literature searching performed in the context of applications for market authorisati...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-4-2019

Final evidence report as part of preparatory work for the setting of Dietary Reference Values for sodium and chloride†, ‡

Final evidence report as part of preparatory work for the setting of Dietary Reference Values for sodium and chloride†, ‡

Published on: Wed, 03 Apr 2019 Final evidence report as part of preparatory work for the setting of Dietary Reference Values for sodium and chloride†, ‡ © European Food Safety Authority, 2015 Final evidence report as part of preparatory work for the setting of Dietary Reference Values for sodium and chloride†, ‡

Europe - EFSA - European Food Safety Authority EFSA Journal

3-4-2019

FDA Posts Adverse Event Report Data for Animal Drugs and Devices Used in Animals to Increase Transparency

FDA Posts Adverse Event Report Data for Animal Drugs and Devices Used in Animals to Increase Transparency

In its continuing commitment to increase transparency, the U.S. Food and Drug Administration’s Center for Veterinary Medicine is announcing today the availability of data from over 30 years of adverse event reports related to animal drugs and devices used in animals.

FDA - U.S. Food and Drug Administration

3-4-2019

FDA takes new steps to increase access to adverse event report data for medical products used in animals

FDA takes new steps to increase access to adverse event report data for medical products used in animals

FDA takes new steps to increase access to adverse event report data for medical products used in animals

FDA - U.S. Food and Drug Administration

30-3-2019

Pesticide Residue Intake Model‐ EFSA PRIMo revision 3.1

Pesticide Residue Intake Model‐ EFSA PRIMo revision 3.1

Published on: Fri, 29 Mar 2019 In January 2018, the guidance document on the use of EFSA PRIMo revision 3 was published in the EFSA Journal. Following feedback from users, the risk assessment tool has been updated, including editorial modifications and corrections of input values used for the calculation of the exposure assessments. This technical report summarises the modifications introduced in EFSA PRIMo revision 3.1. © European Food Safety Authority, 2015 Pesticide Residue Intake Model‐ EFSA PRIMo ...

Europe - EFSA - European Food Safety Authority EFSA Journal

29-3-2019

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

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

Published on: Thu, 28 Mar 2019 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

29-3-2019

Final Report: Applying a tested procedure for the identification of potential emerging chemical risks in the food chain to the substances registered under REACH ‐ REACH 2

Final Report: Applying a tested procedure for the identification of potential emerging chemical risks in the food chain to the substances registered under REACH ‐ REACH 2

Published on: Thu, 28 Mar 2019 This study applied a procedure for the identification of potential emerging chemical risks in the food chain to substances registered under the REACH Regulation that was previously developed and tested in an EFSA‐sponsored pilot study. The selection was limited to substances that (a) were registered with a full registration, (b) met eligibility criteria (e.g. availability of a CAS number and a SMILES notation) and (c) were considered to be inside the applicability domain o...

Europe - EFSA - European Food Safety Authority EFSA Journal

29-3-2019

Peer review of the pesticide risk assessment for the active substance sulfoxaflor in light of confirmatory data submitted

Peer review of the pesticide risk assessment for the active substance sulfoxaflor in light of confirmatory data submitted

Published on: Thu, 28 Mar 2019 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the co‐rapporteur Member State the Czech Republic for the pesticide active substance sulfoxaflor are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

28-3-2019

Fact or Fiction: What to Know About Smoking Cessation and Medications

Fact or Fiction: What to Know About Smoking Cessation and Medications

Tobacco use is the leading preventable cause of death in the United States, resulting in more than 480,000 deaths annually. Almost 70 percent of current smokers report wanting to quit smoking, but quitting can be hard and often takes multiple attempts. A variety of FDA-approved medications are available to help people successfully quit smoking.

FDA - U.S. Food and Drug Administration

27-3-2019

Enforcement Report for the Week of March 27, 2019

Enforcement Report for the Week of March 27, 2019

Recently Updated Records for the Week of March 27, 2019 Last Modified Date: Wednesday, March 20, 2019

FDA - U.S. Food and Drug Administration

26-3-2019

Enforcement Report for the Week of October 26, 2016

Enforcement Report for the Week of October 26, 2016

Recently Updated Records for the Week of October 26, 2016 Last Modified Date: Tuesday, March 26, 2019

FDA - U.S. Food and Drug Administration

26-3-2019

Technical report of the public consultation on the draft ‘Guidance on harmonised risk assessment methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals’

Technical report of the public consultation on the draft ‘Guidance on harmonised risk assessment methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals’

Published on: Mon, 25 Mar 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 draft guidance of the working group of the Scientific Committee ‘Harmonised risk assessment methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals’. The background and the Terms of Reference were prepared by EFSA staff and the working group of the Scienti...

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

20-3-2019

Enforcement Report for the Week of March 20, 2019

Enforcement Report for the Week of March 20, 2019

Recently Updated Records for the Week of March 20, 2019 Last Modified Date: Monday, March 18, 2019

FDA - U.S. Food and Drug Administration

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

Enforcement Report for the Week of March 13, 2019

Enforcement Report for the Week of March 13, 2019

Recently Updated Records for the Week of March 13, 2019 Last Modified Date: Tuesday, March 12, 2019

FDA - U.S. Food and Drug Administration

8-3-2019

Data sources on animal diseases:Country Card of Denmark

Data sources on animal diseases:Country Card of Denmark

Published on: Thu, 07 Mar 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

7-3-2019

Efficacy of methyl ester of conjugated linoleic acid (t10,c12 isomer) for sows and cows for reproduction

Efficacy of methyl ester of conjugated linoleic acid (t10,c12 isomer) for sows and cows for reproduction

Published on: Tue, 05 Mar 2019 A mixture of methylated conjugated linoleic acid (CLA) isomers (t10,c12 and c9,t11) in equal proportions is the subject of this assessment. The active substance is considered to be CLA (t10,c12) methyl ester (ME). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA previously issued an opinion on the safety and efficacy of the product, in which it could not conclude on the efficacy of this additive for sows for reproduction and for cows f...

Europe - EFSA - European Food Safety Authority EFSA Journal

6-3-2019

Enforcement Report for the Week of March 06, 2019

Enforcement Report for the Week of March 06, 2019

Recently Updated Records for the Week of March 06, 2019 Last Modified Date: Friday, March 01, 2019

FDA - U.S. Food and Drug Administration

5-3-2019

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Published on: Fri, 01 Mar 2019 In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one‐generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

New EU report on big data paves the way for action

New EU report on big data paves the way for action

A taskforce on big data in the pharmaceutical area, the HMA-EMA Joint Big Data Taskforce, has just published its first report. The report offers a definition of big data and several recommendations for European authorities that regulate medicines and medical devices.

Danish Medicines Agency

1-3-2019

Pest categorisation of Thrips palmi

Pest categorisation of Thrips palmi

Published on: Thu, 28 Feb 2019 The EFSA Panel on Plant Health (PLH) performed a pest categorisation of Thrips palmi(Thysanoptera: Thripidae), for the EU. T. palmi is listed in Annex IAI of 2000/29 EC. Using molecular methods, cryptic speciation has been shown although no new species from the group have been formally described. Here, we consider T. palmi sensu lato as a defined species native to southern Asia, which has spread to tropical and subtropical countries in Asia, the Pacific, North, Central and...

Europe - EFSA - European Food Safety Authority EFSA Journal

27-2-2019

Enforcement Report for the Week of February 27, 2019

Enforcement Report for the Week of February 27, 2019

Recently Updated Records for the Week of February 27, 2019 Last Modified Date: Wednesday, February 20, 2019

FDA - U.S. Food and Drug Administration

27-2-2019

The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2017

The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2017

Published on: Tue, 26 Feb 2019 The data on antimicrobial resistance in zoonotic and indicator bacteria in 2017, submitted by 28 EU Member States (MSs), were jointly analysed by EFSA and ECDC. Resistance in zoonotic Salmonella and Campylobacter from humans, animals and food, and resistance in indicator Escherichia coli as well as meticillin-resistant Staphylococcus aureus in animals and food were addressed, and temporal trends assessed. ‘Microbiological’ resistance was assessed using epidemiological cut-...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

FoodEx2 maintenance 2016‐2018

FoodEx2 maintenance 2016‐2018

Published on: Fri, 22 Feb 2019 FoodEx2 is a comprehensive food classification and description system released by EFSA in 2011 (revision 1) and replaced in April 2015 by FoodEx2 revision 2, as a consequence of a testing phase. A first maintenance of the system was carried out in 2015 and a second during the years 2016‐2018 in order to evaluate further comments and proposals provided to EFSA by users and stakeholders. This technical report describes the outcome of the second maintenance process, including...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Annual Report of preparatory work on the toxicological studies and animal feeding studies performed under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 during the period 1/3/2017 to 27/11/2018

Annual Report of preparatory work on the toxicological studies and animal feeding studies performed under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 during the period 1/3/2017 to 27/11/2018

Published on: Fri, 22 Feb 2019 This report describes the tasks performed in the period 1/3/2017 to 27/11/2018 under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 on toxicological studies and animal feeding studies included in applications for market authorisation of genetically modified feed/plants under Regulation (EC) No 1829/2003. The tasks cover the check for study adherence to relevant EFSA guidance documents and to OECD Test Guideline no 407 (1995/2008), OECD Test Guideline no 408 (1998) and OECD P...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

FDA-Approved Devices That Keep the Heart Beating

FDA-Approved Devices That Keep the Heart Beating

Cardiovascular devices (or 'heart' devices) such as pacemakers and defibrillators have extended and improved the lives of millions of people worldwide. Learn how the FDA regulates these devices, when to seek medical attention for potential heart issues, and how to report problems.

FDA - U.S. Food and Drug Administration

22-2-2019

Enforcement Report for the Week of February 20, 2019

Enforcement Report for the Week of February 20, 2019

Recently Updated Records for the Week of February 20, 2019 Last Modified Date: Friday, February 22, 2019

FDA - U.S. Food and Drug Administration

22-2-2019

Enforcement Report for the Week of January 23, 2019

Enforcement Report for the Week of January 23, 2019

Recently Updated Records for the Week of January 23, 2019 Last Modified Date: Friday, February 22, 2019

FDA - U.S. Food and Drug Administration

21-2-2019

"Alternative" anti-scale processes: ANSES's recommendations

"Alternative" anti-scale processes: ANSES's recommendations

Today ANSES is publishing its opinion and report on so-called alternative anti-scale (Alt-AS) processes in drinking water distribution systems. The Agency stresses first of all that Alt-AS manufacturers and distributors have a responsibility to provide evidence of the safety and effectiveness of the processes and products they market, and expresses its disappointment at the limited data available in this regard.

France - Agence Nationale du Médicament Vétérinaire

21-2-2019

Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2018

Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2018

Published on: Wed, 20 Feb 2019 The EFSA Scientific Network for Risk Assessment of GMOs (the GMO Network) was established in accordance with EFSA's strategy for cooperation and networking with Member States. The goals of the GMO Network are to improve dialogue among members, build mutual understanding of risk assessment principles, enhance knowledge and confidence in the scientific assessment carried out in the EU, and increase the transparency of the process among Member States and EFSA. The annual repo...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Sweden

Data sources on animal diseases: Country Card of Sweden

Published on: Mon, 18 Feb 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

17-4-2019


Human medicines European public assessment report (EPAR): Ajovy, fremanezumab, Migraine Disorders, Date of authorisation: 28/03/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Ajovy, fremanezumab, Migraine Disorders, Date of authorisation: 28/03/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Ajovy, fremanezumab, Migraine Disorders, Date of authorisation: 28/03/2019, Status: Authorised

Europe - EMA - European Medicines Agency

17-4-2019


Human medicines European public assessment report (EPAR): Tobramycin PARI, tobramycin, Respiratory Tract Infections,Cystic Fibrosis, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Tobramycin PARI, tobramycin, Respiratory Tract Infections,Cystic Fibrosis, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Tobramycin PARI, tobramycin, Respiratory Tract Infections,Cystic Fibrosis, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

17-4-2019


Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid,Arthritis, Juvenile Rheumatoid,Psoriasis,Arthritis, Psoriatic,Spondylitis, Ankylosing,Uveitis,Hidradenitis Suppurativa,Colitis, Ulcerative,Crohn Disease,

Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid,Arthritis, Juvenile Rheumatoid,Psoriasis,Arthritis, Psoriatic,Spondylitis, Ankylosing,Uveitis,Hidradenitis Suppurativa,Colitis, Ulcerative,Crohn Disease,

Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid,Arthritis, Juvenile Rheumatoid,Psoriasis,Arthritis, Psoriatic,Spondylitis, Ankylosing,Uveitis,Hidradenitis Suppurativa,Colitis, Ulcerative,Crohn Disease, Date of authorisation: 02/04/2019, Status: Authorised

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A, Treatment of myasthenia gravis, 21/0

Orphan designation: Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A, Treatment of myasthenia gravis, 21/0

Orphan designation: Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A, Treatment of myasthenia gravis, 21/05/2015, Withdrawn

Europe - EMA - European Medicines Agency

12-4-2019

EU/3/07/440 (Diamond ROC EOOD)

EU/3/07/440 (Diamond ROC EOOD)

EU/3/07/440 (Active substance: Recombinant adeno-associated viral vector containing human alpha-1 antitrypsin gene) - Transfer of orphan designation - Commission Decision (2019)2930 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005871

Europe -DG Health and Food Safety

1-4-2019

EU/3/18/2000 (Amicus Therapeutics Europe Limited)

EU/3/18/2000 (Amicus Therapeutics Europe Limited)

EU/3/18/2000 (Active substance: Recombinant human acid alpha-glucosidase) - Transfer of orphan designation - Commission Decision (2019)2423 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004425

Europe -DG Health and Food Safety

29-3-2019


Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Hyperuricemia,Gout, Date of authorisation: 28/03/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Hyperuricemia,Gout, Date of authorisation: 28/03/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Hyperuricemia,Gout, Date of authorisation: 28/03/2019, Status: Authorised

Europe - EMA - European Medicines Agency

20-3-2019

Pharmacovigilance Inspection Program metrics report: Sep 2017 - Dec 2018

Pharmacovigilance Inspection Program metrics report: Sep 2017 - Dec 2018

Statistics from inspections conducted from 1 September 2017 to 31 December 2018

Therapeutic Goods Administration - Australia

19-3-2019


Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, Date of authorisation: 14/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, Date of authorisation: 14/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, Date of authorisation: 14/01/2019, Status: Authorised

Europe - EMA - European Medicines Agency

18-3-2019

EU/3/14/1247 (Diamond ROC EOOD)

EU/3/14/1247 (Diamond ROC EOOD)

EU/3/14/1247 (Active substance: Autologous dendritic cells pulsed with tumour antigen-derived synthetic peptides (MAGE-1, HER-2, AIM-2, TRP-2, gp-100, and interleukin-13 receptor alpha)) - Transfer of orphan designation - Commission Decision (2019)2146 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003818

Europe -DG Health and Food Safety

14-3-2019


Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

8-3-2019

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Active substance: Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin) - Transfer of orphan designation - Commission Decision (2019)1940 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004447

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/545 (Clinuvel Europe Limited)

EU/3/08/545 (Clinuvel Europe Limited)

EU/3/08/545 (Active substance: [Nle4, D-Phe7]-alpha-melanocyte stimulating hormone) - Transfer of orphan designation - Commission Decision (2019)1948 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004293

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/541 (Clinuvel Europe Limited)

EU/3/08/541 (Clinuvel Europe Limited)

EU/3/08/541 (Active substance: [Nle4, D-Phe7]-alpha-melanocyte stimulating hormone) - Transfer of orphan designation - Commission Decision (2019)1947 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004019

Europe -DG Health and Food Safety

6-3-2019


CAT monthly report of application procedures, guidelines and related documents on advanced therapies: February 2019

CAT monthly report of application procedures, guidelines and related documents on advanced therapies: February 2019

CAT monthly report of application procedures, guidelines and related documents on advanced therapies: February 2019

Europe - EMA - European Medicines Agency

1-3-2019


Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

1-3-2019


Veterinary medicines European public assessment report (EPAR): Evant, Coccidiosis vaccine live for chickens, Date of authorisation: 05/02/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Evant, Coccidiosis vaccine live for chickens, Date of authorisation: 05/02/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Evant, Coccidiosis vaccine live for chickens, Date of authorisation: 05/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

1-3-2019


Veterinary medicines European public assessment report (EPAR): Kriptazen, halofuginone, Date of authorisation: 08/02/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Kriptazen, halofuginone, Date of authorisation: 08/02/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Kriptazen, halofuginone, Date of authorisation: 08/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

26-2-2019


Human medicines European public assessment report (EPAR): Macimorelin Aeterna Zentaris, macimorelin, Diagnostic Techniques, Endocrine, Date of authorisation: 11/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Macimorelin Aeterna Zentaris, macimorelin, Diagnostic Techniques, Endocrine, Date of authorisation: 11/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Macimorelin Aeterna Zentaris, macimorelin, Diagnostic Techniques, Endocrine, Date of authorisation: 11/01/2019, Status: Authorised

Europe - EMA - European Medicines Agency

22-2-2019


Joint audit programme for European Economic Area good-manufacturing-practice inspectorates: Audit report template

Joint audit programme for European Economic Area good-manufacturing-practice inspectorates: Audit report template

Joint audit programme for European Economic Area good-manufacturing-practice inspectorates: Audit report template

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate, Treatment of cystic fibrosis, 19/11/2018, Positive

Orphan designation: cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate, Treatment of cystic fibrosis, 19/11/2018, Positive

Orphan designation: cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate, Treatment of cystic fibrosis, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

19-2-2019


Gilenya-H-C-2202-X-0044-G : EPAR - Assessment Report - Variation

Gilenya-H-C-2202-X-0044-G : EPAR - Assessment Report - Variation

Gilenya-H-C-2202-X-0044-G : EPAR - Assessment Report - Variation

Europe - EMA - European Medicines Agency