Ամիքսին

main_info

  • trade_name:
  • Ամիքսին
  • dosage:
  • 125մգ(6/1x6/) և (10/1x10/), բլիստերում
  • pharmaceutical_form:
  • դեղահատեր թաղանթապատ
  • prescription_type:
  • Առանց դեղատոմսի
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Ամիքսին
    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

Safety of chia seeds (Salvia hispanica L.) as a novel food for extended uses pursuant to Regulation (EU) 2015/2283

Safety of chia seeds (Salvia hispanica L.) as a novel food for extended uses pursuant to Regulation (EU) 2015/2283

Published on: Wed, 17 Apr 2019 Following a request from the European Commission, the EFSA Panel on Nutrition, Novel foods and Food Allergens (NDA) was asked to deliver an opinion on overall safety assessment for chia seeds (Salvia hispanica L.) as a novel food (NF) pursuant to Regulation (EU) 2015/2283 in the light of the increasing dietary intake from the growing number of authorised uses in recent years. The safety assessment of this NF is based on data supplied in seven applications, previous safety ...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

Safety and efficacy of Biomin®DC‐C as a zootechnical feed additive for weaned piglets

Safety and efficacy of Biomin®DC‐C as a zootechnical feed additive for weaned piglets

Published on: Tue, 16 Apr 2019 The additive (trade name Biomin® DC‐C) is a blend of essential oils from oregano (Origanum vulgare L.) and from caraway seed (Carum carvi L.) and three individual compounds (carvacrol, methyl salicylate and l‐menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for weaned piglets at a minimum concentration of 75 mg/kg complete feed and a recommended maximum level of 125 mg/kg complete feed. A tolerance test in which piglets were...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-4-2019

Assessment of the application for renewal of authorisation of GalliPro® (Bacillus subtilis DSM 17299) for chickens for fattening

Assessment of the application for renewal of authorisation of GalliPro® (Bacillus subtilis DSM 17299) for chickens for fattening

Published on: Tue, 16 Apr 2019 GalliPro® is the trade name for a feed additive based on viable cells of a strain of Bacillus subtilis intended for use as a zootechnical additive (gut flora stabiliser) in feed for chickens for fattening. The product is currently authorised for use in chickens for fattening. This opinion concerns the renewal of this authorisation. Bacillus subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establish the safety for the t...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-4-2019

Reporting data on pesticide residues in food and feed according to Regulation (EC) No 396/2005 (2018 data collection)

Reporting data on pesticide residues in food and feed according to Regulation (EC) No 396/2005 (2018 data collection)

Published on: Thu, 11 Apr 2019 According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed, Member States have to monitor pesticide residue levels in food samples and submit the monitoring results to EFSA and the European Commission. The Standard Sample Description (SSD, version 1) is the data model used for reporting the data on analytical measurements of chemical substances occurring in food, feed and water to EFSA. This document is a consolidated version of...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

16-4-2019

Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Published on: Mon, 15 Apr 2019 Following an application from H.J. Heinz Supply Chain Europe B.V. submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Nutrimune and immune defence against pathogens in the gastrointestinal (GI) tract and upper respirator...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-4-2019

Setting an import tolerance for 2,4‐D in soyabeans

Setting an import tolerance for 2,4‐D in soyabeans

Published on: Fri, 12 Apr 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences submitted a request to the competent national authority in Greece to set an import tolerance for the active substance 2,4‐D in genetically modified (GM) soyabeans imported from Canada and the USA. The genetic modification confers tolerance to the herbicide 2,4‐D. The data submitted in support of the request provided sufficient evidence to conclude that residues of parent 2,4‐D and o...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

12-4-2019

Evaluation of the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels

Evaluation of the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels

Published on: Thu, 11 Apr 2019 In 2016, the EFSA Panel on Contaminants in the Food Chain (CONTAM) published a scientific opinion on the acute health risks related to the presence of cyanogenic glycosides (CNGs) in raw apricot kernels in which an acute reference dose (ARfD) of 20 μg/kg body weight (bw) was established for cyanide (CN). In the present opinion, the CONTAM Panel concluded that this ARfD is applicable for acute effects of CN regardless the dietary source. To account for differences in cyanid...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-4-2019

EFSA Workshop on in vitro comparative metabolism studies in regulatory pesticide risk assessment

EFSA Workshop on in vitro comparative metabolism studies in regulatory pesticide risk assessment

Published on: Thu, 11 Apr 2019 The European Union (EU) pesticides Regulation established that in vitro comparative metabolism studies shall be performed. At present an Organisation for Economic Co‐operation and Development (OECD) test guideline for this kind of studies is not available. The European Food Safety Authority (EFSA) Workshop on in vitro comparative metabolism studies in regulatory pesticide risk assessment discussed the use of these studies to identify human metabolites and to support the as...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

10-4-2019

Safety of whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants pursuant to Regulation (EU) 2015/2283

Safety of whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants pursuant to Regulation (EU) 2015/2283

Published on: Tue, 09 Apr 2019 In 2018, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that whey basic protein isolate obtained by ion exchange chromatography from skimmed cow's milk is safe for human consumption under the proposed conditions of use as infant and follow on formula, meal replacement beverages, foods for special medical purposes and food supplements. Following a request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion ...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

7-4-2019

Thorgensen Family Farm Recalls Raw Frozen Ground Pet Food (Rabbit; Duck; Llama; Pork) Because of Possible <em>Listeria Monocytogenes</em> Health Risk

Thorgensen Family Farm Recalls Raw Frozen Ground Pet Food (Rabbit; Duck; Llama; Pork) Because of Possible <em>Listeria Monocytogenes</em> Health Risk

Thogersen Family Farm of Stanwood, WA is voluntarily recalling raw frozen ground pet food because it has the potential to be contaminated with Listeria monocytogenes. The following varieties, packaged in two pound packs, are included in this recall: course ground rabbit, course ground mallard duck, ground llama, and ground pork frozen raw pet food

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

6-4-2019

Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283

Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283

Published on: Fri, 05 Apr 2019 In 2017, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that betaine as a novel food (NF) is safe to be used at a maximum intake level of 6 mg/kg body weight per day in addition to the intake from the background diet. Following the present request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion on betaine by carrying out the assessment for the revised uses and use levels of betaine as proposed by the a...

Europe - EFSA - European Food Safety Authority EFSA Journal

6-4-2019

Guidance on the assessment of the safety of feed additives for the environment

Guidance on the assessment of the safety of feed additives for the environment

Published on: Fri, 05 Apr 2019 This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives used in animal nutrition. It specifically covers the assessment of the safety for the environment. © European Food Safety Authority, 2015 Guidance on the assessment of the safety of feed additives for the environment

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

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

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

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

4-4-2019

Safety and efficacy of an essential oil of Origanum vulgare ssp. hirtum (Link) leetsw. for all poultry species

Safety and efficacy of an essential oil of Origanum vulgare ssp. hirtum (Link) leetsw. for all poultry species

Published on: Wed, 03 Apr 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of an essential oil of Origanum vulgare ssp. hirtum (Link) leetsw. for all poultry species. The essential oil under assessment obtained ■■■■■ is specified to contain carvacrol ■■■■■ and thymol (7%). The remaining 30% of the composition remains uncharacterised. In the absenc...

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

3-4-2019

Assessment of the application for renewal of the authorisation of Natuphos (3‐phytase) as a feed additive for poultry and pigs

Assessment of the application for renewal of the authorisation of Natuphos (3‐phytase) as a feed additive for poultry and pigs

Published on: Tue, 02 Apr 2019 Natuphos® is a feed additive that contains 3‐phytase which is produced ■■■■■ The product is currently authorised for use as a feed additive in chickens for fattening, piglets (weaned) and pigs for fattening, laying hens and turkeys for fattening, ducks, sows, all minor avian species other than ducks and ornamental birds. This scientific opinion concerns the renewal of the authorisation of this additive for those species. The application also included chickens reared for la...

Europe - EFSA - European Food Safety Authority EFSA Journal

2-4-2019

Safety and efficacy of Hemicell®‐L (endo‐1,4‐β‐mannanase) as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding and minor poultry species

Safety and efficacy of Hemicell®‐L (endo‐1,4‐β‐mannanase) as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding and minor poultry species

Published on: Mon, 01 Apr 2019 The additive Hemicell®‐L is a liquid preparation of endo‐1,4‐β‐mannanase that is authorised as a zootechnical feed additive for chickens for fattening. The applicant has requested the renewal of the authorisation, new uses and the modification of the manufacturing process including the change of the production strain. The new production strain is a genetically modified strain of Paenibacillus lentus obtained from a strain that has been evaluated previously by EFSA and cons...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

Natugrain®Wheat TS/TS L

Natugrain®Wheat TS/TS L

Published on: Thu, 28 Mar 2019 Natugrain® Wheat TS is the trade name for a feed additive that contains endo‐1,4‐beta‐xylanase produced ■■■■■ The product is currently authorised for use as a feed additive in chickens for fattening, turkeys for fattening or reared for breeding, ducks, ornamental birds and minor avian species (except ducks and laying birds). This scientific opinion concerns the renewal of the authorisation of this additive for those species. The applicant provided evidence that the additiv...

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

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

17-4-2019


Aztreonam: List of nationally authorised medicinal products - PSUSA/00010178/201808

Aztreonam: List of nationally authorised medicinal products - PSUSA/00010178/201808

Aztreonam: List of nationally authorised medicinal products - PSUSA/00010178/201808

Europe - EMA - European Medicines Agency

17-4-2019


Ciclesonide: List of nationally authorised medicinal products -  PSUSA-00000742-201808

Ciclesonide: List of nationally authorised medicinal products - PSUSA-00000742-201808

Ciclesonide: List of nationally authorised medicinal products - PSUSA-00000742-201808

Europe - EMA - European Medicines Agency

17-4-2019


Rilmenidine: List of nationally authorised medicinal products - PSUSA-00002643-201808

Rilmenidine: List of nationally authorised medicinal products - PSUSA-00002643-201808

Rilmenidine: List of nationally authorised medicinal products - PSUSA-00002643-201808

Europe - EMA - European Medicines Agency

15-4-2019


Cefuroxime sodium (for intracameral use): List of nationally authorised medicinal products - PSUSA/00010206/201805

Cefuroxime sodium (for intracameral use): List of nationally authorised medicinal products - PSUSA/00010206/201805

Cefuroxime sodium (for intracameral use): List of nationally authorised medicinal products - PSUSA/00010206/201805

Europe - EMA - European Medicines Agency

15-4-2019


Ceftriaxone: List of nationally authorised medicinal products - PSUSA/00000613/201805

Ceftriaxone: List of nationally authorised medicinal products - PSUSA/00000613/201805

Ceftriaxone: List of nationally authorised medicinal products - PSUSA/00000613/201805

Europe - EMA - European Medicines Agency

12-4-2019


Pseudoephedrine, acetylsalicylic acid / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00010667/201806

Pseudoephedrine, acetylsalicylic acid / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00010667/201806

Pseudoephedrine, acetylsalicylic acid / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00010667/201806

Europe - EMA - European Medicines Agency

12-4-2019


Tianeptine: List of nationally authorised medicinal products - PSUSA/00002943/201806

Tianeptine: List of nationally authorised medicinal products - PSUSA/00002943/201806

Tianeptine: List of nationally authorised medicinal products - PSUSA/00002943/201806

Europe - EMA - European Medicines Agency

10-4-2019


Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/201807

Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/201807

Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/201807

Europe - EMA - European Medicines Agency

5-4-2019


Paracetamol/pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00002307/201806

Paracetamol/pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00002307/201806

Paracetamol/pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00002307/201806

Europe - EMA - European Medicines Agency

5-4-2019


Metyrapone: List of nationally authorised medicinal products - PSUSA/00002046/201806

Metyrapone: List of nationally authorised medicinal products - PSUSA/00002046/201806

Metyrapone: List of nationally authorised medicinal products - PSUSA/00002046/201806

Europe - EMA - European Medicines Agency

4-4-2019

Kromeya (Fresenius Kabi Deutschland GmbH)

Kromeya (Fresenius Kabi Deutschland GmbH)

Kromeya (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2019)2688 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/005158/0000

Europe -DG Health and Food Safety

4-4-2019

Vizimpro (Pfizer Europe MA EEIG)

Vizimpro (Pfizer Europe MA EEIG)

Vizimpro (Active substance: dacomitinib) - Centralised - Authorisation - Commission Decision (2019)2693 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4779

Europe -DG Health and Food Safety

4-4-2019

Idacio (Fresenius Kabi Deutschland GmbH)

Idacio (Fresenius Kabi Deutschland GmbH)

Idacio (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision C(2019) 2699 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004475/0000

Europe -DG Health and Food Safety

2-4-2019

Jylamvo (Therakind (Europe) Limited)

Jylamvo (Therakind (Europe) Limited)

Jylamvo (Active substance: methotrexate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2624 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3756/T/7

Europe -DG Health and Food Safety

2-4-2019

Arti-Cell Forte (Global Stem cell Technology (G.S.T.) NV)

Arti-Cell Forte (Global Stem cell Technology (G.S.T.) NV)

Arti-Cell Forte (Active substance: Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells) - Centralised - Authorisation - Commission Decision (2019)2625 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4727

Europe -DG Health and Food Safety

1-4-2019


Withdrawn application: Equitend, polycarboxymethyl glucose sulfate acetate, Date of withdrawal: 05/11/2018, Initial authorisation

Withdrawn application: Equitend, polycarboxymethyl glucose sulfate acetate, Date of withdrawal: 05/11/2018, Initial authorisation

Withdrawn application: Equitend, polycarboxymethyl glucose sulfate acetate, Date of withdrawal: 05/11/2018, Initial authorisation

Europe - EMA - European Medicines Agency

1-4-2019

Sialanar (Proveca Pharma Limited)

Sialanar (Proveca Pharma Limited)

Sialanar (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2593 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3883/T/09

Europe -DG Health and Food Safety

1-4-2019

AJOVY (Teva  GmbH)

AJOVY (Teva GmbH)

AJOVY (Active substance: fremanezumab) - Centralised - Authorisation - Commission Decision (2019)2601 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4833

Europe -DG Health and Food Safety

1-4-2019

Febuxostat Krka (Krka d. d., Novo mesto)

Febuxostat Krka (Krka d. d., Novo mesto)

Febuxostat Krka (Active substance: febuxostat) - Centralised - Authorisation - Commission Decision (2019)2585 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4773

Europe -DG Health and Food Safety

1-4-2019

Galafold (Amicus Therapeutics Europe Limited)

Galafold (Amicus Therapeutics Europe Limited)

Galafold (Active substance: migalastat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2580 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004059/T/0020

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

29-3-2019

Nerlynx (Puma Biotechnology B.V.)

Nerlynx (Puma Biotechnology B.V.)

Nerlynx (Active substance: neratinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2579 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4030/T/01

Europe -DG Health and Food Safety

29-3-2019

Coagadex (BPL Bioproducts Laboratory GmbH)

Coagadex (BPL Bioproducts Laboratory GmbH)

Coagadex (Active substance: human coagulation factor X) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2577 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3855/T/14

Europe -DG Health and Food Safety