Քափուրի

main_info

  • trade_name:
  • Քափուրի յուղ
  • dosage:
  • 100մգ/մլ30մլ ապակե շշիկ
  • pharmaceutical_form:
  • լուծույթ արտաքին կիրառման
  • prescription_type:
  • Առանց դեղատոմսի
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Քափուրի յուղ
    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

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

15-4-2019

Leganto (UCB Pharma S.A.)

Leganto (UCB Pharma S.A.)

Leganto (Active substance: Rotigotine) - Centralised - Yearly update - Commission Decision (2019)2992 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Irbesartan Teva (Teva B.V.)

Irbesartan Teva (Teva B.V.)

Irbesartan Teva (Active substance: Irbesartan) - Referral - Commission Decision (2019)2975 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1471/C/1093/32

Europe -DG Health and Food Safety

15-4-2019

Versican Plus Pi/L4 (Zoetis Belgium S.A.)

Versican Plus Pi/L4 (Zoetis Belgium S.A.)

Versican Plus Pi/L4 (Active substance: Canine parainfluenza virus vaccine (live) and canine leptospirosis vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2964 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3683/R/11

Europe -DG Health and Food Safety

15-4-2019

Lokelma (AstraZeneca AB)

Lokelma (AstraZeneca AB)

Lokelma (Active substance: sodium zirconium cyclosilicate) - Centralised - Yearly update - Commission Decision (2019)2987 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Convenia (Zoetis Belgium S.A.)

Convenia (Zoetis Belgium S.A.)

Convenia (Active substance: Cefovecin) - Centralised - Yearly update - Commission Decision (2019)2996 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Suvaxyn PRRS MLV (Zoetis Belgium S.A.)

Suvaxyn PRRS MLV (Zoetis Belgium S.A.)

Suvaxyn PRRS MLV (Active substance: Porcine respiratory and reproductive syndrome virus vaccine (live)) - Centralised - Yearly update - Commission Decision (2019)2995 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Lamivudine Teva (Teva B.V.)

Lamivudine Teva (Teva B.V.)

Lamivudine Teva (Active substance: Lamivudine) - Centralised - Yearly update - Commission Decision (2019)2994 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

15-4-2019

Pemetrexed Lilly (Eli Lilly Nederland B.V.)

Pemetrexed Lilly (Eli Lilly Nederland B.V.)

Pemetrexed Lilly (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2019)2986 of Mon, 15 Apr 2019

Europe -DG Health and Food Safety

12-4-2019

capecitabine

capecitabine

capecitabine (Active substance: capecitabine) - Centralised - Art 28 - (PSUR - Commission Decision (2019)2988 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/531/201804

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2038 (PPD Bulgaria EOOD)

EU/3/18/2038 (PPD Bulgaria EOOD)

EU/3/18/2038 (Active substance: Palovarotene) - Transfer of orphan designation - Commission Decision (2019)2940 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005020

Europe -DG Health and Food Safety

12-4-2019

EU/3/16/1665 (Diamond ROC EOOD)

EU/3/16/1665 (Diamond ROC EOOD)

EU/3/16/1665 (Active substance: Recombinant adeno-associated viral vector containing the human RPGR gene) - Transfer of orphan designation - Commission Decision (2019)2934 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005876

Europe -DG Health and Food Safety

12-4-2019

EU/3/15/1556 (Diamond ROC EOOD)

EU/3/15/1556 (Diamond ROC EOOD)

EU/3/15/1556 (Active substance: Recombinant adeno-associated viral vector containing human CNGA3 gene) - Transfer of orphan designation - Commission Decision (2019)2933 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005873

Europe -DG Health and Food Safety

12-4-2019

EU/3/13/1107 (Diamond ROC EOOD)

EU/3/13/1107 (Diamond ROC EOOD)

EU/3/13/1107 (Active substance: Recombinant adeno-associated viral vector containing the human retinoschisin gene) - Transfer of orphan designation - Commission Decision (2019)2932 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005875

Europe -DG Health and Food Safety

12-4-2019

EU/3/13/1099 (Diamond ROC EOOD)

EU/3/13/1099 (Diamond ROC EOOD)

EU/3/13/1099 (Active substance: Recombinant adeno-associated viral vector containing the human CNGB3 gene) - Transfer of orphan designation - Commission Decision (2019)2931 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005874

Europe -DG Health and Food Safety

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

12-4-2019

EU/3/18/2124 (IntraBio Ireland Ltd)

EU/3/18/2124 (IntraBio Ireland Ltd)

EU/3/18/2124 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2939 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005404

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2059 (IntraBio Ireland Ltd)

EU/3/18/2059 (IntraBio Ireland Ltd)

EU/3/18/2059 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2938 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005399

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1949 (IntraBio Ireland Ltd)

EU/3/17/1949 (IntraBio Ireland Ltd)

EU/3/17/1949 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2936 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005385

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1878 (IntraBio Ireland Ltd)

EU/3/17/1878 (IntraBio Ireland Ltd)

EU/3/17/1878 (Active substance: Ursodeoxycholic acid) - Transfer of orphan designation - Commission Decision (2019)2937 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005394

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1848 (IntraBio Ireland Ltd)

EU/3/17/1848 (IntraBio Ireland Ltd)

EU/3/17/1848 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2935 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005357

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/1977 (GW Pharma (International) B.V)

EU/3/18/1977 (GW Pharma (International) B.V)

EU/3/18/1977 (Active substance: Cannabidivarin) - Transfer of orphan designation - Commission Decision (2019)2929 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004768

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1959 (GW Pharma (International) B.V)

EU/3/17/1959 (GW Pharma (International) B.V)

EU/3/17/1959 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2925 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004767

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1921 (GW Pharma (International) B.V)

EU/3/17/1921 (GW Pharma (International) B.V)

EU/3/17/1921 (Active substance: Cannabidivarin) - Transfer of orphan designation - Commission Decision (2019)2928 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004766

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1920 (GW Pharma (International) B.V)

EU/3/17/1920 (GW Pharma (International) B.V)

EU/3/17/1920 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2927 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004765

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1855 (GW Pharma (International) B.V)

EU/3/17/1855 (GW Pharma (International) B.V)

EU/3/17/1855 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2926 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004607

Europe -DG Health and Food Safety

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

EU/3/14/1339 (GW Pharma (International) B.V)

EU/3/14/1339 (GW Pharma (International) B.V)

EU/3/14/1339 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2923 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004708

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2126 (JVM Europe B.V.)

EU/3/18/2126 (JVM Europe B.V.)

EU/3/18/2126 (Active substance: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment) - Transfer of orphan designation - Commission Decision (2019)2922 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005194

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2035 (JVM Europe B.V.)

EU/3/18/2035 (JVM Europe B.V.)

EU/3/18/2035 (Active substance: Efpegsomatropin) - Transfer of orphan designation - Commission Decision (2019)2921 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005050

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2022 (JVM Europe B.V.)

EU/3/18/2022 (JVM Europe B.V.)

EU/3/18/2022 (Active substance: Glucagon analogue linked to a human immunoglobulin Fc fragment) - Transfer of orphan designation - Commission Decision 2920 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005277

Europe -DG Health and Food Safety

11-4-2019

Esbriet (Roche Registration GmbH)

Esbriet (Roche Registration GmbH)

Esbriet (Active substance: Pirfenidone) - Centralised - Yearly update - Commission Decision (2019)2883 of Thu, 11 Apr 2019

Europe -DG Health and Food Safety

10-4-2019

Versican Plus DHPPi/L4R (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4R (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4R (Active substance: Canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza virus vaccine (live) and canine leptospirosis and rabies vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2850 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/2759/R/14

Europe -DG Health and Food Safety

10-4-2019

Versican Plus L4 (Zoetis Belgium S.A.)

Versican Plus L4 (Zoetis Belgium S.A.)

Versican Plus L4 (Active substance: Canine leptospirosis vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2848 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3680/R/07

Europe -DG Health and Food Safety

10-4-2019

Versican Plus DHPPi/L4 (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4 (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4 (Active substance: Canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza virus vaccine (live) and canine leptospirosis vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2849 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3678/R/13

Europe -DG Health and Food Safety

10-4-2019

M-M-RVAXPRO (MSD VACCINS)

M-M-RVAXPRO (MSD VACCINS)

M-M-RVAXPRO (Active substance: Measles, Mumps and Rubella Vaccine (Live)) - PSUSA - Modification - Commission Decision (2019)2812 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00001937/201805

Europe -DG Health and Food Safety

10-4-2019

Iressa (AstraZeneca AB)

Iressa (AstraZeneca AB)

Iressa (Active substance: gefitinib) - Centralised - Yearly update - Commission Decision (2019)2823 of Wed, 10 Apr 2019

Europe -DG Health and Food Safety

10-4-2019

Lantus (Sanofi-Aventis Deutschland GmbH)

Lantus (Sanofi-Aventis Deutschland GmbH)

Lantus (Active substance: insulin glargine) - Centralised - Yearly update - Commission Decision (2019)2815 of Wed, 10 Apr 2019

Europe -DG Health and Food Safety

10-4-2019

Zerit (Bristol-Myers Squibb Pharma EEIG)

Zerit (Bristol-Myers Squibb Pharma EEIG)

Zerit (Active substance: Stavudine) - Centralised - Yearly update - Commission Decision (2019)2819 of Wed, 10 Apr 2019

Europe -DG Health and Food Safety

10-4-2019

Actraphane (Novo Nordisk A/S)

Actraphane (Novo Nordisk A/S)

Actraphane (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2813 of Wed, 10 Apr 2019

Europe -DG Health and Food Safety

10-4-2019

Orencia (Bristol-Myers Squibb Pharma EEIG)

Orencia (Bristol-Myers Squibb Pharma EEIG)

Orencia (Active substance: abatacept) - Centralised - Yearly update - Commission Decision (2019)2818 of Wed, 10 Apr 2019

Europe -DG Health and Food Safety

10-4-2019

DuoResp Spiromax (Teva Pharma B.V.)

DuoResp Spiromax (Teva Pharma B.V.)

DuoResp Spiromax (Active substance: budesonide / formoterol) - Centralised - Renewal - Commission Decision (2019)2810 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002348/R/0027

Europe -DG Health and Food Safety

10-4-2019

BiResp Spiromax (Teva Pharma B.V.)

BiResp Spiromax (Teva Pharma B.V.)

BiResp Spiromax (Active substance: budesonide / formoterol) - Centralised - Renewal - Commission Decision (2019)2811 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/003890/R/0027

Europe -DG Health and Food Safety

10-4-2019

Capecitabine medac (medac Gesellschaft fUr klinische SpezialprAparate mbH)

Capecitabine medac (medac Gesellschaft fUr klinische SpezialprAparate mbH)

Capecitabine medac (Active substance: capecitabine) - PSUSA - Modification - Commission Decision (2019)2817 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00000531/201804

Europe -DG Health and Food Safety

4-4-2019

Deltyba (Otsuka Novel Products GmbH)

Deltyba (Otsuka Novel Products GmbH)

Deltyba (Active substance: delamanid) - Centralised - Annual renewal - Commission Decision (2019)2687 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002552/R/0033

Europe -DG Health and Food Safety