851-012 FRESA DIAMANTATA

Informazioni principali

  • Nome commerciale:
  • 851-012 FRESA DIAMANTATA
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Dispositivo medico

Documenti

  • per il pubblico:
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  • per i professionisti:
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Localizzazione

  • Disponibile in:
  • 851-012 FRESA DIAMANTATA
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • DISPOSITIVI PER ODONTOIATRIA CONSERVATIVA ED ENDODONZIA - ALTRI

Altre informazioni

Status

  • Fonte:
  • Ministero della Salute - Italia
  • Stato dell'autorizzazione:
  • N
  • Data dell'autorizzazione:
  • 13-03-2010
  • 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.

15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Peer review of the pesticide risk assessment of the active substance clodinafop (variant evaluated clodinafop‐propargyl)

Peer review of the pesticide risk assessment of the active substance clodinafop (variant evaluated clodinafop‐propargyl)

Published on: Fri, 16 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Greece and co‐rapporteur Member State Germany for the pesticide active substance clodinafop‐propargyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of clodinafop‐p...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dimetho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

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

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

Published on: Wed, 03 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Ireland for the pesticide active substance ethoprophos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of ethopro...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

31-8-2018

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

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

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co‐rapporteur Member State, Sweden, for the pesticide active substance carvone are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

21-8-2018

Postmarketing Requirements and Commitments: Reports

Postmarketing Requirements and Commitments: Reports

Added: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability (FY2012)

FDA - U.S. Food and Drug Administration

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

16-7-2018

Determinazioni AIFA (16/07/2018)

Determinazioni AIFA (16/07/2018)

L'Agenzia Italiana del Farmaco rende disponibili un elenco di Determine riguardanti la classificazione ai sensi dell'art. 12 comma 5 legge 8 novembre 2012 n. 189 di medicinali per uso umano - approvati con procedura centralizzata.

Italia - AIFA - Agenzia Italiana del Farmaco

6-6-2018

Philippe Reignault appointed Director of the Plant Health Laboratory and Director of Plant Health at ANSES

Philippe Reignault appointed Director of the Plant Health Laboratory and Director of Plant Health at ANSES

On 4 June, Philippe Reignault was appointed Director of the ANSES Plant Health Laboratory and will also take over from Charles Manceau as Director of Plant Health, with effect from July. Professor of Plant Biology and Diseases at the Littoral Côte d'Opale University since 2010 and Chair of ANSES's Expert Committee on Plant Health since 2012, he will now be responsible for overall coordination of ANSES's scientific work in plant health and protection.

France - Agence Nationale du Médicament Vétérinaire

22-5-2018

Determinazioni AIFA (22/05/2018)

Determinazioni AIFA (22/05/2018)

L'Agenzia Italiana del Farmaco rende disponibili un elenco di Determine riguardanti la classificazione ai sensi dell'art. 12 comma 5 legge 8 novembre 2012 n. 189 di medicinali per uso umano - approvati con procedura centralizzata.

Italia - AIFA - Agenzia Italiana del Farmaco

11-5-2018

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.

FDA - U.S. Food and Drug Administration

3-7-2014

More clinical trials to Denmark

More clinical trials to Denmark

The number of clinical trial applications increased by 35 trials (14%) from 2012 to 2013, which is the highest level in seven years. The increase covers both companies and researchers according to the Danish Health and Medicines Authority's annual report 2013 on clinical trials of medicines in humans.

Danish Medicines Agency

17-1-2013

Danish Pharmacovigilance Update, 20 December 2012

Danish Pharmacovigilance Update, 20 December 2012

In this issue of Danish Pharmacovigilance Update: The Danish Health and Medicines Authority encourages doctors to be aware of suspected long-term adverse reactions from the use of SSRIs in children and adolescents.

Danish Medicines Agency

17-1-2013

Danish Pharmacovigilance Update, 15 November 2012

Danish Pharmacovigilance Update, 15 November 2012

In this issue of Danish Pharmacovigilance Update: Chlorhexidine and the risk of anaphylactic reaction.

Danish Medicines Agency

15-11-2012

Danish Pharmacovigilance Update, 18 October 2012

Danish Pharmacovigilance Update, 18 October 2012

In this issue of Danish Pharmacovigilance Update, read about: Risk of developing hepatotoxicity in patients undergoing treatment with agomelatine (Valdoxan®)

Danish Medicines Agency

17-10-2012

Danish Pharmacovigilance Update, 20 September 2012

Danish Pharmacovigilance Update, 20 September 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: New definition of adverse reactions due to new European legislation on pharmacovigilance.

Danish Medicines Agency

6-9-2012

Danish Pharmacovigilance Update, 16 August 2012

Danish Pharmacovigilance Update, 16 August 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Maximum single dose of intravenous ondansetron (Zofran® and others) now restricted to 16 mg.

Danish Medicines Agency

3-8-2012

Danish Pharmacovigilance Update, 21 June 2012

Danish Pharmacovigilance Update, 21 June 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Decrease in the number of intoxications and suicide attempts using drugs containing acetylsalicylic acid or paracetamol.

Danish Medicines Agency

31-7-2012

Danish Pharmacovigilance Update, 24 May 2012

Danish Pharmacovigilance Update, 24 May 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Drug Analysis Prints involving data from more than 14,000 Danish adverse reaction reports available at the Danish Health and Medicines Authority’s website.

Danish Medicines Agency

4-7-2012

Danish Pharmacovigilance Update, 19 April 2012

Danish Pharmacovigilance Update, 19 April 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Split and crushed tablets containing finasteride may pose a risk for pregnant and fertile women.

Danish Medicines Agency

19-6-2012

Danish Pharmacovigilance Update, 15 March 2012

Danish Pharmacovigilance Update, 15 March 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: A new registry study has investigated the frequency of malformations in newborns after treating the mother with antidepressants (SSRI) during the pregnancy.

Danish Medicines Agency

14-6-2012

Enforcement Report for the Week of June 13, 2012

Enforcement Report for the Week of June 13, 2012

FDA - U.S. Food and Drug Administration

7-6-2012

Enforcement Report for the Week of June 6, 2012

Enforcement Report for the Week of June 6, 2012

FDA - U.S. Food and Drug Administration

31-5-2012

Enforcement Report for the Week of May 30, 2012

Enforcement Report for the Week of May 30, 2012

FDA - U.S. Food and Drug Administration

24-5-2012

Enforcement Report for the Week of May 23, 2012

Enforcement Report for the Week of May 23, 2012

FDA - U.S. Food and Drug Administration

17-5-2012

Enforcement Report for the Week of May 16, 2012

Enforcement Report for the Week of May 16, 2012

FDA - U.S. Food and Drug Administration

10-5-2012

Enforcement Report for the Week of May 9, 2012

Enforcement Report for the Week of May 9, 2012

FDA - U.S. Food and Drug Administration

3-5-2012

Enforcement Report for the Week of May 2, 2012

Enforcement Report for the Week of May 2, 2012

FDA - U.S. Food and Drug Administration

26-4-2012

Enforcement Report for the Week of April 25, 2012

Enforcement Report for the Week of April 25, 2012

FDA - U.S. Food and Drug Administration

18-4-2012

Enforcement Report for the Week of April 18, 2012

Enforcement Report for the Week of April 18, 2012

FDA - U.S. Food and Drug Administration

13-4-2012

Enforcement Report for the Week of April 11, 2012

Enforcement Report for the Week of April 11, 2012

FDA - U.S. Food and Drug Administration

5-4-2012

Enforcement Report for the Week of April 4, 2012

Enforcement Report for the Week of April 4, 2012

FDA - U.S. Food and Drug Administration

29-3-2012

Enforcement Report for the Week of March 28, 2012

Enforcement Report for the Week of March 28, 2012

FDA - U.S. Food and Drug Administration

23-3-2012

Enforcement Report for the Week of March 21, 2012

Enforcement Report for the Week of March 21, 2012

FDA - U.S. Food and Drug Administration

15-3-2012

Enforcement Report for the Week of March 14, 2012

Enforcement Report for the Week of March 14, 2012

FDA - U.S. Food and Drug Administration

8-3-2012

Enforcement Report for the Week of March 7 2012

Enforcement Report for the Week of March 7 2012

FDA - U.S. Food and Drug Administration

5-3-2012

Danish Pharmacovigilance Update, 16 February 2012

Danish Pharmacovigilance Update, 16 February 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Risk of overdose with methotrexate in the treatment of rheumatoid arthritis as well as intensified monitoring of heart rate and blood pressure in connection with treatment with Gilenya.

Danish Medicines Agency

1-3-2012

Enforcement Report for the Week of February 29 2012

Enforcement Report for the Week of February 29 2012

FDA - U.S. Food and Drug Administration

23-2-2012

Enforcement Report for the Week of February 22, 2012

Enforcement Report for the Week of February 22, 2012

FDA - U.S. Food and Drug Administration

22-2-2012

Decision on general conditional reimbursement for alendronate-containing medicines

Decision on general conditional reimbursement for alendronate-containing medicines

In cooperation with the Reimbursement Committee, we have decided to grant alendronate-containing medicines general conditional reimbursement from 5 March 2012. Reimbursement is conditional as it is reserved for patients with low-energy hip fractures. For any other patients who are treated with alendronate, the doctor must apply for single reimbursement, and the guiding criteria for single reimbursement remain unchanged for these patients. Alendronate is used for the treatment of osteoporosis (brittle bon...

Danish Medicines Agency

11-1-2019


Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Europe - EMA - European Medicines Agency

22-11-2018


Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lym

Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lym

Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lymphocytic leukaemia, 06/12/2012, Withdrawn

Europe - EMA - European Medicines Agency

22-11-2018

Selincro (H. Lundbeck A/S)

Selincro (H. Lundbeck A/S)

Selincro (Active substance: nalmefene) - PSUSA - Modification - Commission Decision (2018)7889 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10120/201802

Europe -DG Health and Food Safety

16-11-2018

Ontruzant (Samsung Bioepis NL B.V.)

Ontruzant (Samsung Bioepis NL B.V.)

Ontruzant (Active substance: trastuzumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7553 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004323/T/0012

Europe -DG Health and Food Safety

12-7-2018

Tabelle farmaci di classe A e H al 17/04/2018

Tabelle farmaci di classe A e H al 17/04/2018

Al fine di consentire la prescrizione per principio attivo disposta dall’articolo 15, comma 11-bis, del decreto legge 6 luglio 2012 n.95, convertito con modificazioni dalla Legge 7 agosto 2012 n. 135, l’Agenzia Italiana del Farmaco rende disponibili per tutti gli Operatori sanitari, le tabelle contenenti l’elenco dei farmaci di fascia A, dispensati dal Servizio sanitario Nazionale, ordinati rispettivamente per principio attivo e per nome commerciale.

Italia - AIFA - Agenzia Italiana del Farmaco

12-7-2018

Tabelle farmaci di classe A e H al 15/03/2018

Tabelle farmaci di classe A e H al 15/03/2018

Al fine di consentire la prescrizione per principio attivo disposta dall’articolo 15, comma 11-bis, del decreto legge 6 luglio 2012 n.95, convertito con modificazioni dalla Legge 7 agosto 2012 n. 135, l’Agenzia Italiana del Farmaco rende disponibili per tutti gli Operatori sanitari, le tabelle contenenti l’elenco dei farmaci di fascia A, dispensati dal Servizio sanitario Nazionale, ordinati rispettivamente per principio attivo e per nome commerciale.

Italia - AIFA - Agenzia Italiana del Farmaco

29-6-2018

#FDAInnovationChallenge https://twitter.com/HHSGov/status/1012707386061012994 …

#FDAInnovationChallenge https://twitter.com/HHSGov/status/1012707386061012994 …

#FDAInnovationChallenge https://twitter.com/HHSGov/status/1012707386061012994 …

FDA - U.S. Food and Drug Administration

29-6-2018

#FDAInnovationChallenge https://twitter.com/SGottliebFDA/status/1012725536626536448 …

#FDAInnovationChallenge https://twitter.com/SGottliebFDA/status/1012725536626536448 …

#FDAInnovationChallenge https://twitter.com/SGottliebFDA/status/1012725536626536448 …

FDA - U.S. Food and Drug Administration

29-6-2018

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (Active substance: L-cystine bis(N'-methylpiperazide)) - Orphan designation - Commission Decision (2018)4181 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/012/18

Europe -DG Health and Food Safety

13-6-2018

Scientific guideline:  Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, draft: consultation open

Scientific guideline: Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, draft: consultation open

This concept paper proposes the development of a single guideline on the clinical evaluation of medicinal products indicated for treatment of bacterial infections. The development of this single guideline is intended to merge, revise and add to the guidance that is currently included in two separate documents as follows: guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2), adopted in 2011 and in force since 2012 and the addendum ...

Europe - EMA - European Medicines Agency

1-6-2018

Tabelle farmaci di classe A e H al 15/02/2018

Tabelle farmaci di classe A e H al 15/02/2018

Al fine di consentire la prescrizione per principio attivo disposta dall’articolo 15, comma 11-bis, del decreto legge 6 luglio 2012 n.95, convertito con modificazioni dalla Legge 7 agosto 2012 n. 135, l’Agenzia Italiana del Farmaco rende disponibili per tutti gli Operatori sanitari, le tabelle contenenti l’elenco dei farmaci di fascia A e H, dispensati dal Servizio sanitario Nazionale, ordinati rispettivamente per principio attivo e per nome commerciale.

Italia - AIFA - Agenzia Italiana del Farmaco

15-5-2018

Tabelle farmaci di classe A e H al 15/01/2018 (errata corrige)

Tabelle farmaci di classe A e H al 15/01/2018 (errata corrige)

Al fine di consentire la prescrizione per principio attivo disposta dall’articolo 15, comma 11-bis, del decreto legge 6 luglio 2012 n.95, convertito con modificazioni dalla Legge 7 agosto 2012 n. 135, l’Agenzia Italiana del Farmaco rende disponibili per tutti gli Operatori sanitari, le tabelle contenenti l’elenco dei farmaci di fascia A, dispensati dal Servizio sanitario Nazionale, ordinati rispettivamente per principio attivo e per nome commerciale.

Italia - AIFA - Agenzia Italiana del Farmaco

15-5-2018

Odomzo (Sun Pharmaceutical Industries Europe BV)

Odomzo (Sun Pharmaceutical Industries Europe BV)

Odomzo (Active substance: sonidegib) - Centralised - Yearly update - Commission Decision (2018)3012 of Tue, 15 May 2018

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (IDEA Innovative Drug European Associates Limited)

EU/3/18/2012 (Active substance: Genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII) - Orphan designation - Commission Decision (2018)2408 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/17

Europe -DG Health and Food Safety

12-3-2018

Tabelle farmaci di classe A e H al 15/12/2017 (errata corrige)

Tabelle farmaci di classe A e H al 15/12/2017 (errata corrige)

Al fine di consentire la prescrizione per principio attivo disposta dall’articolo 15, comma 11-bis, del decreto legge 6 luglio 2012 n.95, convertito con modificazioni dalla Legge 7 agosto 2012 n. 135, l’Agenzia Italiana del Farmaco rende disponibili per tutti gli Operatori sanitari, le tabelle contenenti l’elenco dei farmaci di fascia A e H, dispensati dal Servizio sanitario Nazionale, ordinati rispettivamente per principio attivo e per nome commerciale.

Italia - AIFA - Agenzia Italiana del Farmaco