BANDE ROTH MOLARI UL 69-262-80 + 21-602-20

Informazioni principali

  • Nome commerciale:
  • BANDE ROTH MOLARI UL 69-262-80 + 21-602-20
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Dispositivo medico

Documenti

  • per il pubblico:
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Localizzazione

  • Disponibile in:
  • BANDE ROTH MOLARI UL 69-262-80 + 21-602-20
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • BANDE PER ORTODONZIA

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • S
  • Data dell'autorizzazione:
  • 13-01-2010
  • Ultimo aggiornamento:
  • 09-08-2016
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.

    Richiedi il foglio illustrativo per il pubblico.

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 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 two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Biljartster Therese Klompenhouwer geridderd

Biljartster Therese Klompenhouwer geridderd

Op het Nederlands Kampioenschap driebanden tussen de wedstrijden door werd Therese Klompenhouwer verrast met een bijzondere boodschap. Minister Bruno Bruins (Sport) kon in Berlicum melden dat de Koning haar heeft benoemd tot Ridder in de Orde van Oranje Nassau.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

1-1-2019

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classifi...

FDA - U.S. Food and Drug Administration

26-12-2018

Enforcement Report for the Week of December 26, 2018

Enforcement Report for the Week of December 26, 2018

Recently Updated Records for the Week of December 26, 2018 Last Modified Date: Friday, December 21, 2018

FDA - U.S. Food and Drug Administration

22-12-2018

Modification of the existing maximum residue level for captan in hops

Modification of the existing maximum residue level for captan in hops

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level for the active substance captan in hops. The data submitted in support of the request were found to be insufficient to conclude whether the existing residue definitions are appropriate for hops. Although the number of residue ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

Peer review of the pesticide risk assessment of the active substance propanil

Peer review of the pesticide risk assessment of the active substance propanil

Published on: Thu, 20 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance propanil and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of t...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

Avian influenza overview August – November 2018

Avian influenza overview August – November 2018

Published on: Thu, 20 Dec 2018 Between 16 August and 15 November 2018, 14 highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments in Bulgaria and seven HPAI A(H5N6) outbreaks, one in captive birds in Germany and six in wild birds in Denmark and the Netherlands were reported in the European Union (EU). No human infection due to HPAI A(H5N8) and A(H5N6) viruses have been reported in Europe so far. Seroconversion of people exposed during outbreaks in Russia has been reported in...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

17-12-2018


Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...

Europe - EFSA - European Food Safety Authority Publications

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

Europe - EMA - European Medicines Agency

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

Europe - EMA - European Medicines Agency

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).

Health Canada

27-11-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carc...

FDA - U.S. Food and Drug Administration

22-11-2018

Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients and/or unacceptable contaminant(s).

Health Canada

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 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 Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

24-12-2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement for 16 November 2018 published

Therapeutic Goods Administration - Australia

21-12-2018

Consultation: Fees and charges proposal 2019-20

Consultation: Fees and charges proposal 2019-20

The TGA is seeking comments from interested parties on the proposed changes in fees and charges for 2019-2020. Closing date: 8 February 2018

Therapeutic Goods Administration - Australia

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

19-12-2018


European Medicines Agency closed 21 December 2018 to 2 January 2019

European Medicines Agency closed 21 December 2018 to 2 January 2019

European Medicines Agency closed 21 December 2018 to 2 January 2019

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

12-12-2018

Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, March 2019

Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, March 2019

Proposed Amendments to the Poisons Standard are now available for public comment. Closing date: 21 January 2019

Therapeutic Goods Administration - Australia

12-12-2018


Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Europe - EMA - European Medicines Agency

12-12-2018

Oncaspar (Les Laboratoires Servier)

Oncaspar (Les Laboratoires Servier)

Oncaspar (Active substance: pegaspargase) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8757 of Wed, 12 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3789/T/21

Europe -DG Health and Food Safety

12-12-2018

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Active substance: efmoroctocog alfa) - Centralised - Variation - Commission Decision (2018)8678 of Wed, 12 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3964/X/21

Europe -DG Health and Food Safety

7-12-2018


Chlorprothixene: List of nationally authorised medicinal products - PSUSA/00000717/201803

Chlorprothixene: List of nationally authorised medicinal products - PSUSA/00000717/201803

Chlorprothixene: List of nationally authorised medicinal products - PSUSA/00000717/201803

Europe - EMA - European Medicines Agency

5-12-2018


Cilazapril, cilazapril / hydrochlorothiazide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation -  PSUSA-00000749-201802

Cilazapril, cilazapril / hydrochlorothiazide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00000749-201802

Cilazapril, cilazapril / hydrochlorothiazide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA-00000749-201802

Europe - EMA - European Medicines Agency

5-12-2018


Cilazapril, cilazapril / hydrochlorothiazide: List of nationally authorised medicinal products -  PSUSA-00000749-201802

Cilazapril, cilazapril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA-00000749-201802

Cilazapril, cilazapril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA-00000749-201802

Europe - EMA - European Medicines Agency

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Mirvaso (Galderma International)

Mirvaso (Galderma International)

Mirvaso (Active substance: brimonidine) - Centralised - Renewal - Commission Decision (2018)7977 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2642/R/21

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Active substance: 3-(3-(3,5-dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid) - Orphan designation - Commission Decision (2018)7790 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/096/18

Europe -DG Health and Food Safety

21-11-2018

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)7841 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/121/X/22

Europe -DG Health and Food Safety

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

21-11-2018

EU/3/17/1962 (MWB Consulting S.A.R.L.)

EU/3/17/1962 (MWB Consulting S.A.R.L.)

EU/3/17/1962 (Active substance: Humanised Fc-engineered monoclonal antibody against CD19) - Transfer of orphan designation - Commission Decision (2018)7815 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/155/17/T/01

Europe -DG Health and Food Safety

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2102 (IQVIA RDS Ireland Limited)

EU/3/18/2102 (IQVIA RDS Ireland Limited)

EU/3/18/2102 (Active substance: Apraglutide) - Orphan designation - Commission Decision (2018)7812 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/115/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (Active substance: Setmelanotide) - Orphan designation - Commission Decision (2018)7811 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/143/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2099 (Celgene Europe Limited)

EU/3/18/2099 (Celgene Europe Limited)

EU/3/18/2099 (Active substance: Lisocabtagene maraleucel) - Orphan designation - Commission Decision (2018)7809 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2098 (Bayer AG)

EU/3/18/2098 (Bayer AG)

EU/3/18/2098 (Active substance: Larotrectinib) - Orphan designation - Commission Decision (2018)7808 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/117/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2097 (Bayer AG)

EU/3/18/2097 (Bayer AG)

EU/3/18/2097 (Active substance: Larotrectinib) - Orphan designation - Commission Decision (2018)7807 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/116/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2096 (Hansa Medical AB)

EU/3/18/2096 (Hansa Medical AB)

EU/3/18/2096 (Active substance: Imlifidase) - Orphan designation - Commission Decision (2018)7806 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/093/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2095 (United Neuroscience Limited)

EU/3/18/2095 (United Neuroscience Limited)

EU/3/18/2095 (Active substance: Ile-Ser-Ile-Thr-Glu-Ile-Lys-Gly-Val-Ile-Val-His-Arg-Ile-Glu-Thr-Ile-Leu-Phe-Lys-Lys-Lys-Lys-Glu-Met-Pro-Ser-Glu-Glu-Gly-Tyr-Gln-Asp) - Orphan designation - Commission Decision (2018)7805 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/146/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2094 (Y-mAbs Therapeutics A/S)

EU/3/18/2094 (Y-mAbs Therapeutics A/S)

EU/3/18/2094 (Active substance: Anti-GD2 monoclonal antibody 3F8 humanised) - Orphan designation - Commission Decision (2018)7804 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/126/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2093 (Sanquin Plasma Products B.V.)

EU/3/18/2093 (Sanquin Plasma Products B.V.)

EU/3/18/2093 (Active substance: Human apotransferrin) - Orphan designation - Commission Decision (2018)7803 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/109/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2092 (Dr Regenold GmbH)

EU/3/18/2092 (Dr Regenold GmbH)

EU/3/18/2092 (Active substance: H-Arg-Pro-Lys-Pro-Gln-Gln-Phe-2Thi-Gly-Leu-Met(O2)-NH2-DOTA-213-bismuth) - Orphan designation - Commission Decision (2018)7802 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/145/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2091 (Pharma Gateway AB)

EU/3/18/2091 (Pharma Gateway AB)

EU/3/18/2091 (Active substance: Glucagon) - Orphan designation - Commission Decision (2018)7801 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/108/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2090 (Pfizer Europe MA EEIG)

EU/3/18/2090 (Pfizer Europe MA EEIG)

EU/3/18/2090 (Active substance: Fidanacogene elaparvovec) - Orphan designation - Commission Decision (2018)7799 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/112/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2087 (Consejo Superior de Investigaciones Cientificas (CSIC))

EU/3/18/2087 (Consejo Superior de Investigaciones Cientificas (CSIC))

EU/3/18/2087 (Active substance: Etamsylate) - Orphan designation - Commission Decision (2018)7796 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/135/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate) - Orphan designation - Commission Decision (2018)7795 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/106/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Active substance: Autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand) - Orphan designation - Commission Decision (2018)7794 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/18

Europe -DG Health and Food Safety