SAT 2002 komponent 3

Primær information

  • Handelsnavn:
  • SAT 2002 komponent 3 Pulver bejdse
  • Lægemiddelform:
  • Pulver bejdse
  • Sammensætning:
  • 980 g/kg thiram
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

  • for den brede offentlighed:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for offentligheden.

  • for sundhedspersonale:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for sundhedspersonale.

Lokation

  • Fås i:
  • SAT 2002 komponent 3 Pulver bejdse
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Udgået
  • Sidste ændring:
  • 08-02-2018
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.

15-2-2019

Assessment of genetically modified oilseed rape T45 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐012)

Assessment of genetically modified oilseed rape T45 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐012)

Published on: Thu, 14 Feb 2019 Following the submission of application EFSA‐GMO‐RX‐012 under Regulation (EC) No1829/2003 from BayerCropScienceN.V., the Panelon Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified oilseed rape T45, for food and feed uses, excluding cultivation within the European Unio...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-2-2019

Evaluation of confirmatory data following the Article 12 MRL review for spinosad

Evaluation of confirmatory data following the Article 12 MRL review for spinosad

Published on: Mon, 04 Feb 2019 The applicant Dow AgroSciences Ltd submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for spinosad in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to residue trials on globe artichokes, flowering brassica and the nature of residues in processed commodities were satisfactorily addressed. A new feedi...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Guidelines for reporting molecular typing data through EFSA's Data Collection Framework

Guidelines for reporting molecular typing data through EFSA's Data Collection Framework

Published on: Fri, 25 Jan 2019 The European Food Safety Authority (EFSA) received the mandate from the European Commission (EC), in accordance with Article 31 of Regulation (EC) No. 178/2002, to collect data on the molecular testing of food‐borne pathogens such as Salmonella, Listeria monocytogenes and Shiga toxin‐producing Escherichia coli (STEC) from food, feed, animals and the related environment, to contribute to the epidemiological investigations of food‐borne outbreaks and to the identification of...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-1-2019

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 9: suitability of taxonomic units notified to EFSA until September 2018

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 9: suitability of taxonomic units notified to EFSA until September 2018

Published on: Thu, 24 Jan 2019 The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre‐evaluation to support safety risk assessments of biological agents performed by EFSA's Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected by ‘qualifications’ which should be assessed at the strain lev...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-1-2019

Satur Farms’ Recall of Baby Spinach Affects Prepared Food Items from Whole Foods Market Stores in Eight States

Satur Farms’ Recall of Baby Spinach Affects Prepared Food Items from Whole Foods Market Stores in Eight States

In response to a recall by Satur Farms, Whole Foods Market is voluntarily recalling various prepared foods items in eight states containing baby spinach because of a potential contamination of Salmonella.

FDA - U.S. Food and Drug Administration

24-1-2019

Product Recall Because of Possible Health Risk

Product Recall Because of Possible Health Risk

Satur Farms, 3705 Alvah's Lane, Cutchogue, NY 11935 is voluntarily recalling Baby Spinach and Mesclun with the specific lot numbers listed below because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

FDA - U.S. Food and Drug Administration

21-1-2019

Ruling by the French administrative court of Lyon: ANSES contests any error of assessment

Ruling by the French administrative court of Lyon: ANSES contests any error of assessment

ANSES has examined the ruling of 15 January 2019 by the French administrative court of Lyon overriding the marketing authorisation decision for Roundup Pro 360. It should be noted that, in order to protect human and environmental health, ANSES is responsible for implementing European regulations on the national level with regard to the marketing authorisation of regulated products (plant protection products, biocides and veterinary medicinal products). It also contributes to improving these regulations b...

France - Agence Nationale du Médicament Vétérinaire

18-1-2019

Updating of summaries of product characteristics due to changed ATC codes for 2019

Updating of summaries of product characteristics due to changed ATC codes for 2019

Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2019.

Danish Medicines Agency

15-1-2019

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Published on: Mon, 14 Jan 2019 Following the submission of application EFSA‐GMO‐RX‐009 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V., the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean A2704‐12, for food and feed uses, import and processing, excluding cultivation within th...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Published on: Fri, 11 Jan 2019 Following a request from the European Commission, the 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 HOSTAZYM® X as a feed additive for rabbits for fattening. HOSTAZYM® X contains endo‐1,4‐beta‐xylanase produced by a strain of Trichoderma citrinoviride and is available in liquid and solid formulations. It is authorised as a feed additive for chickens for fattening, turkeys f...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Published on: Fri, 11 Jan 2019 Lantharenol® is a feed additive consisting of lanthanum carbonate octahydrate. It is currently authorised as a zootechnical additive (decrease in phosphorous excretion via urine) for cats; this opinion concerns the renewal of the authorisation. In 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Lantharenol® as a feed additive for cats. The applicant has provided data demonstrating th...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Pest categorisation of Grapholita inopinata

Pest categorisation of Grapholita inopinata

Published on: Wed, 19 Dec 2018 The EFSA Panel on Plant Health (PLH) performed a pest categorisation of Grapholita inopinata, (Lepidoptera: Tortricidae), the Manchurian fruit moth, for the territory of the EU. G. inopinata is a well‐defined species that is recognised as a major pest of Malus spp. in Far East Russia, Eastern Siberia and northern China. G. inopinata is less common in Japan where it is not a serious pest. G. inopinata is not known to occur in the EU. G. inopinata is listed in Annex IIAI of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-2-2019

Yargesa (Piramal Critical Care B.V.)

Yargesa (Piramal Critical Care B.V.)

Yargesa (Active substance: miglustat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1329 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004016/T/0005

Europe -DG Health and Food Safety

12-2-2019

Kriptazen (Virbac)

Kriptazen (Virbac)

Kriptazen (Active substance: halofuginone) - Centralised - Authorisation - Commission Decision (2019)1097 of Tue, 12 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4868

Europe -DG Health and Food Safety

8-2-2019


Information required for early identification of a need for pre-authorisation GCP inspections

Information required for early identification of a need for pre-authorisation GCP inspections

Information required for early identification of a need for pre-authorisation GCP inspections

Europe - EMA - European Medicines Agency

8-2-2019


EMA launches checklist to facilitate validation for initial marketing authorisation applications

EMA launches checklist to facilitate validation for initial marketing authorisation applications

EMA launches checklist to facilitate validation for initial marketing authorisation applications

Europe - EMA - European Medicines Agency

8-2-2019

Accofil (Accord Healthcare S.L.U.)

Accofil (Accord Healthcare S.L.U.)

Accofil (Active substance: Filgrastim) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1033 of Fri, 08 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3956/T/27

Europe -DG Health and Food Safety

8-2-2019

Axumin (Blue Earth Diagnostics Ireland Ltd)

Axumin (Blue Earth Diagnostics Ireland Ltd)

Axumin (Active substance: fluciclovine (18F)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1046 of Fri, 08 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004197/T/0012

Europe -DG Health and Food Safety

8-2-2019

Eptifibatide Accord (Accord Healthcare S.L.U.)

Eptifibatide Accord (Accord Healthcare S.L.U.)

Eptifibatide Accord (Active substance: eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1036 of Fri, 08 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4104/T/05

Europe -DG Health and Food Safety

8-2-2019

Ivabradine Accord (Accord Healthcare S.L.U.)

Ivabradine Accord (Accord Healthcare S.L.U.)

Ivabradine Accord (Active substance: ivabradine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1034 of Fri, 08 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4241/T/03

Europe -DG Health and Food Safety

7-2-2019


Veterinary medicines European public assessment report (EPAR): Isemid, Torasemide, Date of authorisation: 09/01/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Isemid, Torasemide, Date of authorisation: 09/01/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Isemid, Torasemide, Date of authorisation: 09/01/2019, Status: Authorised

Europe - EMA - European Medicines Agency

7-2-2019

EVANT (Laboratorios Hipra, S.A.)

EVANT (Laboratorios Hipra, S.A.)

EVANT (Active substance: Coccidiosis vaccine live for chickens) - Centralised - Authorisation - Commission Decision (2019)939 of Thu, 07 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/004902/0000

Europe -DG Health and Food Safety

7-2-2019

Consultation: Reforms to the generic medicine market authorisation process

Consultation: Reforms to the generic medicine market authorisation process

The TGA is seeking comments from interested parties on the proposed generic medicines reforms. Closing date: 21 March 2019

Therapeutic Goods Administration - Australia

6-2-2019

Zycortal (Dechra Regulatory B.V.)

Zycortal (Dechra Regulatory B.V.)

Zycortal (Active substance: desoxycortone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)914 of Wed, 06 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3782/T/02

Europe -DG Health and Food Safety

5-2-2019


Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Bevespi Aerosphere, glycopyrronium / formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 18/12/2018, Status: Authorised

Europe - EMA - European Medicines Agency

4-2-2019

Zoely (Theramex Ireland Limited)

Zoely (Theramex Ireland Limited)

Zoely (Active substance: nomegestrol / estradiol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)850 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/1213/T/47

Europe -DG Health and Food Safety

4-2-2019

Memantine Accord (Accord Healthcare S.L.U.)

Memantine Accord (Accord Healthcare S.L.U.)

Memantine Accord (Active substance: memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)844 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/T/12

Europe -DG Health and Food Safety

4-2-2019

Olanzapine Glenmark (Glenmark Arzneimittel GmbH)

Olanzapine Glenmark (Glenmark Arzneimittel GmbH)

Olanzapine Glenmark (Active substance: Olanzapine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)853 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/1085/T/29

Europe -DG Health and Food Safety

4-2-2019

Olanzapine Glenmark Europe (Glenmark Arzneimittel GmbH)

Olanzapine Glenmark Europe (Glenmark Arzneimittel GmbH)

Olanzapine Glenmark Europe (Active substance: Olanzapine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)856 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/1086/T/27

Europe -DG Health and Food Safety

4-2-2019

Feraccru (Norgine B.V.)

Feraccru (Norgine B.V.)

Feraccru (Active substance: ferric maltol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)857 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2733/T/20

Europe -DG Health and Food Safety

4-2-2019

Combivir (ViiV Healthcare BV)

Combivir (ViiV Healthcare BV)

Combivir (Active substance: lamivudine / zidovudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)858 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/190/T/94

Europe -DG Health and Food Safety

4-2-2019

Xaluprine (Nova Laboratories Ireland Limited)

Xaluprine (Nova Laboratories Ireland Limited)

Xaluprine (Active substance: Mercaptopurine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)846 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002022/T/0020

Europe -DG Health and Food Safety

1-2-2019


Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, Date of authorisation: 18/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, Date of authorisation: 18/12/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, Date of authorisation: 18/12/2018, Status: Authorised

Europe - EMA - European Medicines Agency

1-2-2019


Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

1-2-2019


Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Europe - EMA - European Medicines Agency

1-2-2019


Withdrawn application: Vynpenta (previously AvacopanChemoCentryx), avacopan, Date of withdrawal: 31/01/2019, Initial authorisation

Withdrawn application: Vynpenta (previously AvacopanChemoCentryx), avacopan, Date of withdrawal: 31/01/2019, Initial authorisation

Withdrawn application: Vynpenta (previously AvacopanChemoCentryx), avacopan, Date of withdrawal: 31/01/2019, Initial authorisation

Europe - EMA - European Medicines Agency

28-1-2019

Clomicalm (Elanco GmbH)

Clomicalm (Elanco GmbH)

Clomicalm (Active substance: Clomipramine hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)720 of Mon, 28 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/000039/T/0030

Europe -DG Health and Food Safety

28-1-2019


Human medicines European public assessment report (EPAR): Jivi, damoctocog alfa pegol, Hemophilia A, Date of authorisation: 22/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Jivi, damoctocog alfa pegol, Hemophilia A, Date of authorisation: 22/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Jivi, damoctocog alfa pegol, Hemophilia A, Date of authorisation: 22/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

25-1-2019

Luxturna (Novartis Europharm Limited)

Luxturna (Novartis Europharm Limited)

Luxturna (Active substance: voretigene neparvovec) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)675 of Fri, 25 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4451/T/01

Europe -DG Health and Food Safety

25-1-2019

Juluca (ViiV Healthcare BV)

Juluca (ViiV Healthcare BV)

Juluca (Active substance: dolutegravir / rilpivirine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)679 of Fri, 25 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4427/T/07

Europe -DG Health and Food Safety

25-1-2019

Bronchitol (Pharmaxis Europe Limited)

Bronchitol (Pharmaxis Europe Limited)

Bronchitol (Active substance: Mannitol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)687 of Fri, 25 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/1252/T/35

Europe -DG Health and Food Safety

23-1-2019

Lonquex (Teva B.V.)

Lonquex (Teva B.V.)

Lonquex (Active substance: lipegfilgrastim) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)623 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002556/T/0046

Europe -DG Health and Food Safety

23-1-2019

Eladynos (Radius International Ltd)

Eladynos (Radius International Ltd)

Eladynos (Active substance: abaloparatide) - Refusal of authorisation - Commission Decision (2019)70 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4157

Europe -DG Health and Food Safety

23-1-2019


Withdrawn application: Graspa, asparaginase, Date of withdrawal: 22/06/2018, Initial authorisation

Withdrawn application: Graspa, asparaginase, Date of withdrawal: 22/06/2018, Initial authorisation

Withdrawn application: Graspa, asparaginase, Date of withdrawal: 22/06/2018, Initial authorisation

Europe - EMA - European Medicines Agency

22-1-2019


Human medicines European public assessment report (EPAR): Silodosin Recordati, silodosin, Prostatic Hyperplasia, Date of authorisation: 07/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Silodosin Recordati, silodosin, Prostatic Hyperplasia, Date of authorisation: 07/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Silodosin Recordati, silodosin, Prostatic Hyperplasia, Date of authorisation: 07/01/2019, Status: Authorised

Europe - EMA - European Medicines Agency

17-1-2019

Savene (Clinigen Healthcare B.V.)

Savene (Clinigen Healthcare B.V.)

Savene (Active substance: Dexrazoxane) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)206 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/000682/T/0038

Europe -DG Health and Food Safety

16-1-2019

Erleada (Janssen-Cilag International NV)

Erleada (Janssen-Cilag International NV)

Erleada (Active substance: apalutamide) - New authorisation - Commission Decision (2019)257 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4452

Europe -DG Health and Food Safety

16-1-2019

Vepacel (Ology Bioservices Ireland LTD)

Vepacel (Ology Bioservices Ireland LTD)

Vepacel (Active substance: Prepandemic influenza vaccine (A/H5N1) (whole virion, Vero cell derived, inactivated)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)196 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2089/T/19

Europe -DG Health and Food Safety

16-1-2019

Orbactiv (Menarini International Operations Luxembourg S.A.)

Orbactiv (Menarini International Operations Luxembourg S.A.)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)187 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/003785/T/0022

Europe -DG Health and Food Safety

16-1-2019

Ovaleap (Theramex Ireland Limited)

Ovaleap (Theramex Ireland Limited)

Ovaleap (Active substance: Follitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)189 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002608/T/0027

Europe -DG Health and Food Safety

15-1-2019

Macimorelin Aeterna Zentaris (Aterna Zentaris GmbH)

Macimorelin Aeterna Zentaris (Aterna Zentaris GmbH)

Macimorelin Aeterna Zentaris (Active substance: macimorelin) - New authorisation - Commission Decision (2019)203 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4660

Europe -DG Health and Food Safety

15-1-2019

Vizamyl (GE Healthcare AS)

Vizamyl (GE Healthcare AS)

Vizamyl (Active substance: flutemetamol (18F)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)201 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2557/T/18

Europe -DG Health and Food Safety

15-1-2019

Symkevi (Vertex Pharmaceuticals (Ireland) Limited)

Symkevi (Vertex Pharmaceuticals (Ireland) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)188 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004682/T/0003

Europe -DG Health and Food Safety

11-1-2019

Syvazul BTV (LABORATORIOS SYVA, S.A.U.)

Syvazul BTV (LABORATORIOS SYVA, S.A.U.)

Syvazul BTV (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)) - New authorisation - Commission Decision (2019)135 of Fri, 11 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/V/C/4611

Europe -DG Health and Food Safety

11-1-2019

Isemid (Ceva SantE Animale)

Isemid (Ceva SantE Animale)

Isemid (Active substance: Torasemide) - New authorisation - Commission Decision (2019)134 of Fri, 11 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4345

Europe -DG Health and Food Safety

9-1-2019

Silodosin Recordati (Recordati Ireland Ltd)

Silodosin Recordati (Recordati Ireland Ltd)

Silodosin Recordati (Active substance: silodosin) - New authorisation - Commission Decision (2019)73 of Wed, 09 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4964

Europe -DG Health and Food Safety

2-1-2019

Panretin (Eisai GmbH)

Panretin (Eisai GmbH)

Panretin (Active substance: alitretinoin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)9197 of Wed, 02 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/000279/T/0043

Europe -DG Health and Food Safety

20-12-2018

Namuscla (Lupin Europe GmbH)

Namuscla (Lupin Europe GmbH)

Namuscla (Active substance: Mexiletine) - New authorisation - Commission Decision (2018)9133 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4584

Europe -DG Health and Food Safety

20-12-2018

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (Active substance: glycopyrronium bromide / formoterol) - New authorisation - Commission Decision (2018)9127 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4245

Europe -DG Health and Food Safety

20-12-2018

Ledaga (Helsinn Birex Pharmaceuticals Ltd.)

Ledaga (Helsinn Birex Pharmaceuticals Ltd.)

Ledaga (Active substance: chlormethine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)9124 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2826/T/8

Europe -DG Health and Food Safety

19-12-2018

Zubsolv (Mundipharma Corporation (Ireland) Limited)

Zubsolv (Mundipharma Corporation (Ireland) Limited)

Zubsolv (Active substance: buprenorphine / naloxone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)9063 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004407/T/0003

Europe -DG Health and Food Safety

19-12-2018

Zejula (TESARO Bio Netherlands B.V.)

Zejula (TESARO Bio Netherlands B.V.)

Zejula (Active substance: niraparib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)9058 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4249/T/7

Europe -DG Health and Food Safety

19-12-2018

Epivir (ViiV Healthcare BV)

Epivir (ViiV Healthcare BV)

Epivir (Active substance: Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)9060 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000107/T/0109

Europe -DG Health and Food Safety