ATTAIN SELECT II 6248DEL

Glavna informacija

  • Trgovački naziv:
  • ATTAIN SELECT II 6248DEL
  • Razred:
  • III
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • Medicinski uređaj
  • Proizveden od:
  • Medtronic Inc., SAD

Dokument

  • za javnost:
  • Informativni letak za ovaj proizvod trenutno nije dostupan, možete poslati zahtjev na našu službu za korisnike, a mi ćemo vas obavijestiti čim smo u mogućnosti da ga dobiju.


    Zatražite informativni letak za javnost.

Lokalizacija

  • Na raspolaganju u:
  • ATTAIN SELECT II 6248DEL
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • sustav za uvođenje katetera koji olakšava ugradnju elektrode u željenu srčanu venu na lijevoj strani srca

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • 381-13/86-10-02
  • Datum autorizacije:
  • 28-10-2010
  • Zadnje ažuriranje:
  • 05-06-2018
  • Informativni letak za ovaj proizvod trenutno nije dostupan, možete poslati zahtjev na našu službu za korisnike, a mi ćemo vas obavijestiti čim smo u mogućnosti da ga dobiju.

    Zatražite informativni letak za javnost.

14-11-2018

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump.

FDA - U.S. Food and Drug Administration

2-11-2018

Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn

Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn

Frito-Lay announced a voluntary recall of select 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn because they were inadvertently filled with cheese flavored tortilla chips that contain undeclared milk ingredients. The recalled bags were sold only in the two variety packs listed below.

FDA - U.S. Food and Drug Administration

30-10-2018

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Flushmate recalls Flushmate II 501-B Pressure-Assisted Flushing Systems

Flushmate recalls Flushmate II 501-B Pressure-Assisted Flushing Systems

The Flushmate II 501-B system can burst at or near the vessel weld seam releasing stored pressure. This pressure can lift the tank lid and shatter the tank, posing impact and laceration hazards to consumers and property damage.

Health Canada

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 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 the first 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 Me...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

3-8-2018

HP Hood LLC Recalls Select Units of Half-Gallon Refrigerated Vanilla Almond Breeze Almond Milk due to Possible Milk Allergen

HP Hood LLC Recalls Select Units of Half-Gallon Refrigerated Vanilla Almond Breeze Almond Milk due to Possible Milk Allergen

HP Hood LLC is voluntarily recalling a limited number of half-gallon (1.89 L) cartons of refrigerated Vanilla Almond Breeze almond milk because the product may contain milk, an allergen not listed on the label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The product is safe to consume unless you have a milk allergy or sensitivity. To date, there has been one report of an allergic reaction. Medical ...

FDA - U.S. Food and Drug Administration

31-7-2018

Heat wave: Retailers may refrain from selling non-prescription drugs

Heat wave: Retailers may refrain from selling non-prescription drugs

Due to the summer heat, the Danish Medicines Agency has given Danish retailers dispensation from the requirement to stock a basic selection of medicines if they are having trouble keeping the temperature in their store cool enough for proper storage of the drugs. This dispensation applies until 1 September.

Danish Medicines Agency

17-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs

Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs

FDA describes innovative approaches to increase access to a broader selection of nonprescription drug products for consumers

FDA - U.S. Food and Drug Administration

16-7-2018

Utz Quality Foods Issues Allergy Alert on Undeclared Soy in Utz® Carolina Style Barbeque Potato Chips

Utz Quality Foods Issues Allergy Alert on Undeclared Soy in Utz® Carolina Style Barbeque Potato Chips

Utz® Quality Foods, LLC., is voluntarily recalling select expiration dates of Utz® Carolina Style Barbeque Potato Chips due to undeclared soy allergen. This recall was initiated after learning a certain number of packages were mislabeled. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

21-6-2018

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, 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 b...

FDA - U.S. Food and Drug Administration

16-6-2018

Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk

Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Limited Quantity of Vegetable Trays in a Multistate Outbreak of Cyclospora Illnesses in Select Retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, and Wisconsin, Because of Possible Health Risk

Del Monte Fresh Produce N.A., Inc. ("Del Monte Fresh") announced today, the voluntary recall of a limited quantity of 6 oz., 12 oz. and 28 oz. vegetable trays containing fresh broccoli, cauliflower, celery sticks, carrots, and dill dip sold to select retailers in Illinois, Indiana, Iowa, Michigan, Minnesota and Wisconsin. Del Monte was notified by state agencies of the outbreak and its potential involvement.

FDA - U.S. Food and Drug Administration

25-10-2018

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Active substance: enzalutamide) - Centralised - 2-Monthly update - Commission Decision (2018)7132 of Thu, 25 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2639/II/39G

Europe -DG Health and Food Safety

30-9-2018

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied.  Selected applications will be announced in November. For more information about the challenge, click the link:   https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk  pic.twitter.com/pFJZ39oGJC

FDA - U.S. Food and Drug Administration

21-9-2018

Regulatory and procedural guideline:  Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1, draft: consultation open

Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1, draft: consultation open

The guideline, which was developed to encourage optimal use and to minimise selection of antimicrobial resistance (AMR), was revised in order to improve consistency of the summary of product characteristics (SPCs) for antimicrobial products in the EU Member States.

Europe - EMA - European Medicines Agency

17-9-2018

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid u

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid u

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid use disorder. #FDA

FDA - U.S. Food and Drug Administration

14-9-2018

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here:  http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

FDA - U.S. Food and Drug Administration

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

4-9-2018

Epoetin alfa Hexal (Hexal AG)

Epoetin alfa Hexal (Hexal AG)

Epoetin alfa Hexal (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5857 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/726/II/WS/1406

Europe -DG Health and Food Safety

4-9-2018

Binocrit (Sandoz GmbH)

Binocrit (Sandoz GmbH)

Binocrit (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5856 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/725/II/WS/1406

Europe -DG Health and Food Safety

4-9-2018

Spinraza (Biogen Idec Limited)

Spinraza (Biogen Idec Limited)

Spinraza (Active substance: nusinersen) - Centralised - 2-Monthly update - Commission Decision (2018)5862 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/II/4

Europe -DG Health and Food Safety

30-8-2018

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (Active substance: influenza vaccine (live attenuated, nasal)) - Centralised - Variation - Commission Decision (2018)5815 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2617/II/82

Europe -DG Health and Food Safety

29-8-2018

Coagadex (Bio Products Laboratory Ltd)

Coagadex (Bio Products Laboratory Ltd)

Coagadex (Active substance: human coagulation factor X) - Centralised - 2-Monthly update - Commission Decision (2018)5772 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3855/II/07

Europe -DG Health and Food Safety

29-8-2018

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (Active substance: mepolizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5770 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3860/II/13/G

Europe -DG Health and Food Safety

27-8-2018

RoActemra (Roche Registration GmbH)

RoActemra (Roche Registration GmbH)

RoActemra (Active substance: tocilizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5687 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/955/II/78

Europe -DG Health and Food Safety

22-8-2018

Lenvima (Eisai Europe Limited)

Lenvima (Eisai Europe Limited)

Lenvima (Active substance: lenvatinib) - Centralised - 2-Monthly update - Commission Decision (2018)5627 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3727/II/11/G

Europe -DG Health and Food Safety

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

7-8-2018

Inovelon (Eisai Limited)

Inovelon (Eisai Limited)

Inovelon (Active substance: Rufinamide) - Centralised - 2-Monthly update - Commission Decision (2018)5424 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/660/II/45

Europe -DG Health and Food Safety

6-8-2018

Rapamune (Pfizer Limited)

Rapamune (Pfizer Limited)

Rapamune (Active substance: sirolimus) - Centralised - 2-Monthly update - Commission Decision (2018)5384 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/273/II/164

Europe -DG Health and Food Safety

6-8-2018

Dexdor (Orion Corporation)

Dexdor (Orion Corporation)

Dexdor (Active substance: dexmedetomidine) - Centralised - 2-Monthly update - Commission Decision (2018)5377 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2268/II/26

Europe -DG Health and Food Safety

3-8-2018

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (Active substance: Adenovirus associated viral vector serotype 2/8 containing the human CNGA3 gene) - Orphan designation - Commission Decision (2018)5274 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/18

Europe -DG Health and Food Safety

1-8-2018

Eylea (Bayer AG)

Eylea (Bayer AG)

Eylea (Active substance: aflibercept) - Centralised - 2-Monthly update - Commission Decision (2018)5222 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2392/II/45

Europe -DG Health and Food Safety

1-8-2018

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Active substance: nivolumab) - Centralised - 2-Monthly update - Commission Decision (2018)5204 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3985/II/41

Europe -DG Health and Food Safety

30-7-2018

NovoEight (Novo Nordisk A/S)

NovoEight (Novo Nordisk A/S)

NovoEight (Active substance: turoctocog alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5093 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2719/II/23

Europe -DG Health and Food Safety

13-7-2018

Briviact (UCB Pharma S.A.)

Briviact (UCB Pharma S.A.)

Briviact (Active substance: brivaracetam) - Centralised - 2-Monthly update - Commission Decision (2018)4715 of Fri, 13 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3898/II/10/G

Europe -DG Health and Food Safety

9-7-2018

Pexion (Boehringer Ingelheim Vetmedica GmbH)

Pexion (Boehringer Ingelheim Vetmedica GmbH)

Pexion (Active substance: Imepitoin) - Centralised - 2-Monthly update - Commission Decision (2018)4433 of Mon, 09 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2543/II/11/G

Europe -DG Health and Food Safety

4-7-2018

Tecentriq (Roche Registration GmbH)

Tecentriq (Roche Registration GmbH)

Tecentriq (Active substance: atezolizumab) - Centralised - 2-Monthly update - Commission Decision (2018)4336 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4143/II/10

Europe -DG Health and Food Safety

4-7-2018

Simponi (Janssen Biologics B.V.)

Simponi (Janssen Biologics B.V.)

Simponi (Active substance: golimumab) - Centralised - 2-Monthly update - Commission Decision (2018) 4350 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/992/II/79

Europe -DG Health and Food Safety

3-7-2018

Samsca (Otsuka Pharmaceutical Europe Ltd)

Samsca (Otsuka Pharmaceutical Europe Ltd)

Samsca (Active substance: tolvaptan) - Centralised - 2-Monthly update - Commission Decision (2018) 4250 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/980/II/31

Europe -DG Health and Food Safety

3-7-2018

Jinarc (Otsuka Pharmaceutical Europe Ltd)

Jinarc (Otsuka Pharmaceutical Europe Ltd)

Jinarc (Active substance: tolvaptan) - Centralised - 2-Monthly update - Commission Decision (2018)4243 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/II/16

Europe -DG Health and Food Safety

29-6-2018

Porcilis PCV M Hyo (Intervet International B.V.)

Porcilis PCV M Hyo (Intervet International B.V.)

Porcilis PCV M Hyo (Active substance: Porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)) - Centralised - 2-Monthly update - Commission Decision (2018)4166 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/3796/II/7

Europe -DG Health and Food Safety

20-6-2018

Blincyto (Amgen Europe B.V.)

Blincyto (Amgen Europe B.V.)

Blincyto (Active substance: blinatumomab) - Centralised - Authorisation - Switch to non-conditional - Commission Decision (2018)3953 of Wed, 20 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3731/II/9

Europe -DG Health and Food Safety

11-6-2018

Cimzia (UCB Pharma S.A.)

Cimzia (UCB Pharma S.A.)

Cimzia (Active substance: certolizumab pegol ) - Centralised - 2-Monthly update - Commission Decision (2018)3768 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1037/II/65

Europe -DG Health and Food Safety

11-6-2018

Cerdelga (Genzyme Europe B.V.)

Cerdelga (Genzyme Europe B.V.)

Cerdelga (Active substance: eliglustat) - Centralised - 2-Monthly update - Commission Decision (2018)3754 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3724/II/15/G

Europe -DG Health and Food Safety

11-6-2018

TAGRISSO (AstraZeneca AB)

TAGRISSO (AstraZeneca AB)

TAGRISSO (Active substance: osimertinib) - Centralised - 2-Monthly update - Commission Decision (2018)3757 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4124/II/19

Europe -DG Health and Food Safety

11-6-2018

Pradaxa (Boehringer Ingelheim International GmbH)

Pradaxa (Boehringer Ingelheim International GmbH)

Pradaxa (Active substance: dabigatran etexilate mesilate) - Centralised - 2-Monthly update - Commission Decision (2018)3755 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/829/II/108

Europe -DG Health and Food Safety

11-6-2018

Xultophy (Novo Nordisk A/S)

Xultophy (Novo Nordisk A/S)

Xultophy (Active substance: insulin degludec / liraglutide) - Centralised - 2-Monthly update - Commission Decision (2018)3779 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2647/II/23

Europe -DG Health and Food Safety

11-6-2018

Bexsero (GlaxoSmithKline Vaccines S.r.l.)

Bexsero (GlaxoSmithKline Vaccines S.r.l.)

Bexsero (Active substance: Meningococcal group B Vaccine (rDNA, component, adsorbed)) - Centralised - 2-Monthly update - Commission Decision (2018)3769 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2333/II/59

Europe -DG Health and Food Safety

6-6-2018

Prolia (Amgen Europe B.V.)

Prolia (Amgen Europe B.V.)

Prolia (Active substance: denosumab) - Centralised - 2-Monthly update - Commission Decision (2018) 3685 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1120/II/68

Europe -DG Health and Food Safety

4-6-2018

Yervoy (Bristol-Myers Squibb Pharma EEIG)

Yervoy (Bristol-Myers Squibb Pharma EEIG)

Yervoy (Active substance: ipilimumab) - Centralised - 2-Monthly update - Commission Decision (2018)3618 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2213/II/55

Europe -DG Health and Food Safety

4-6-2018

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Active substance: apixaban) - Centralised - 2-Monthly update - Commission Decision (2018)3616 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2148/II/50

Europe -DG Health and Food Safety

4-6-2018

Alecensa (Roche Registration GmbH)

Alecensa (Roche Registration GmbH)

Alecensa (Active substance: alectinib) - Centralised - 2-Monthly update - Commission Decision (2018)3621 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4164/II/10

Europe -DG Health and Food Safety

30-5-2018

The FDA will accept submissions from June 1, 2018, through Sept. 30, 2018, and intends to announce the selected applicants in November 2018.  #FDAInnovationChallenge

The FDA will accept submissions from June 1, 2018, through Sept. 30, 2018, and intends to announce the selected applicants in November 2018. #FDAInnovationChallenge

The FDA will accept submissions from June 1, 2018, through Sept. 30, 2018, and intends to announce the selected applicants in November 2018. #FDAInnovationChallenge

FDA - U.S. Food and Drug Administration

30-5-2018

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use dis

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use dis

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use disorder. #FDA MedicalDevice

FDA - U.S. Food and Drug Administration