أزينيل ٢٠٠ ملغ/٥ ملل معلق

المعلومات الرئيسية

  • اسم تجاري:
  • أزينيل ٢٠٠ ملغ/٥ ملل معلق
  • الشكل الصيدلاني:
  • POWDER FOR SUSPENSION
  • طريقة التعاطي:
  • PER OS
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • HAUPT PHARMA LATINA S.R.L, ITALY

المستندات

الأقلمة

  • متاح في:
  • أزينيل ٢٠٠ ملغ/٥ ملل معلق
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • AZITHROMYCIN
  • الخصائص العلاجية:
  • Infections caused by susceptible organisms in lower respiratory tract including bronchitis and pneumonia, skin and soft tissue infections, otitis media, upper respiratory tract infections including sinusitis and pharyngitis, tonsilitis, also in the treatment of uncomplicated genital infections due to chlamydia trachomatis.

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 118262982800
  • تاريخ الترخيص:
  • 01-03-2010
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة: نشرة المعلومات, خصائص المنتج

Azenilcapsules&suspension,17 Mar2013

שיגרהתא ) יגרלא ( ליעפהרמוחל הפורתההליכמרשאםיפסונהםיביכרמהמדחאלכלוא .

תיגרלאהבוגתלשרבעםהלשישםילוחלוזהפורתתתלןיא תצובקמתרחאהקיטויביטנאלואןיצימורתיראלוארישכתל

םידילוטקהואםידילורקמה .

טוגראהתחפשממתופורתבשמתשמךניה ) ןוגכ : הנרגימבלופיטלתופורת .(

םיחקורהתונקתיפלןכרצלןולע ) םירישכת ( משתה " ו - 1986

דבלבאפורםשרמיפלעתקוושמהפורתה

קזוחהוותרוצרישכתהםש

תוסומכלינזא 0 5 2 מ " ג

לינזא ףיחרת 200 מ " ג / 5 מ " ל

הליכמהסומכלכ : ןיצימורתיזא ) טארדיהידתרוצב ( mg 250 (as Dihydrate) Azithromycin

לכ 5 מ " לשל םיליכמףיחרתה : ןיצימורתיזא ) טארדיהידתרוצב ( mg 0 0 2 (as Dihydrate) Azithromycin

תמישר רישכתבםיינגרלאוםיליעפיתלבםירמוח קרפב 6 .

הפורתבשמתשתםרטבופוסדעןולעהתאןויעבארק . הזןולע יתיצמתעדימליכמ הפורתהלע . לאשךלשיםא תופסונתו ,

חקורהלאואאפורהלאהנפ .

לופיטלהמשרנוזהפורת ךרובע . םירחאלהתואריבעתלא . םהלקיזהלהלולעאיה םג יכךלהארנםא יאופרהםבצמ המוד

ךלשל . ליגלתחתמתוקוניתוםידלילללכךרדבתדעוימהניאוזהפורת 6 םישדוח .

1 . לעגונבתעדלילעהמ הפורת ?

ללשיגרהתאםא זוטק , הסומכה זוטקללםישיגרהםישנאלצאהיגרלאלםורגלהלולעוזוטקלהליכמ .

םירכוסלשהיוקלהגיפסמלבוסהתאםא , תרכוסילוחבשומישברהזיהלשיןכלורכוסליכמףיחרתה .

םירכוסלשהיוקלהגיפסמםילבוסהםילוחבלופיטלםיאתמוניארישכתה .

יאוולהתועפותלעעדימל , הנפאנא קרפל 4 .

הפורתהתדעוימהמל ?

רישכתלםישיגרהםיקדייחידילעםימרגנהםימוהיזבלופיטלהקיטויביטנא .

ופרתהצובק י תיט :

םידילורקמהגוסמהקיטויביטנא .

2 . ינפל ה הפורתבשומיש

תבשמתשהלןיא הפור םא :

הקינמואןוירהבךניהםא , קינהלואןוירהלסנכיהלתננכתמ .

סךניהםא תוילכהואדבכהדוקפתביוקילמרבעבתלבסואלבו .

דוקפתביוקילמרבעבתלבסואלבוסךניהםא בלה .

רבעבתלבסואלבוסךניהםא תרכוסמ .

תועגונהתודחוימתורהזא ל הפורתבשומיש

םא התא שיגר / ןוזמלה יהשלכהפורתלואוהשלכ , לעעידוהלךילע - תליטנינפלאפורלךכ הפורתה .

זוטקללשיגרהתאםא , זוטקללםישיגרהםישנאלצאהיגרלאלםורגלהלולעוזוטקלהליכמהפורתה .

םירכוסלשהיוקלהגיפסמלבוסהתאםא , תרכוסילוחבשומישברהזיהלשיןכלורכוסליכמףיחרתה .

ואחקולהתאםא הנוזתיפסותוםשרמאללתופורתללוכתורחאתופורתהנורחאלתחקל , חקורלואאפורלךכלערפס .

דחוימב חקולהתאםאחקורהואאפורהתאעדיילשי :

טהתלחתהינפלאפורבץעוויהלילבמהפורתבשמתשהלןיא לופי :

Azenilcapsules&suspension,17 Mar2013

חידגונםירישכת הצמו – םדבןיצימורתיזאתמרלעעיפשמבולישהשןוויכמ .

ןירופסולקיצ ) ןוסיחהתכרעמיוכידל ( - בקעמבתויהלשיןכלוםדבןירופסולקיצתומרתאהלעמבולישהשןוויכמ .

ןירמוקגוסמהשירקידגונםירישכת ) ןירפרוו ( – ירחאבקעמבתויהלשי ידדמ השירק .

םיניטטס ) סלוכתדרוהלתופורת לורט ( - יכמ ו יאוולתועפותבהילעלםורגללולעבולישהשןו םיניטטסהלש .

ןידובודיז ) ל בלופיט סדייא ( תומרתאהלעמבולישהשןוויכמ ןידובודיז םדב .

באניפלנ רי ) ל בלופיט סדייא ( םדבןיצימורתיזאתומרתאהלעמבולישהשןוויכמ .

ןיטובאפיר ) תפחשבלופיטלהקיטויביטנא ( – ישהשןוויכמ לולעבול הינפורטיונברושקתויהל .

ןידנפרט ) היגרלאבלופיטל ( – בצקתוערפהברושקתויהללולעבולישהשןוויכמ .

ןיליפואית ) המתסאל ( - םדבןיליפואיתתומרתאהלעמבולישהשןוויכמ .

םעדחיבשמתשהלןיא טוגראלשתורזגנ ) הנרגימבלופיטלתופורתןוגכ ( .

ה בשומיש הפורת ןוזמו

תוסו - לוטילשי ינפלהעשתוחפל לכוא הירחאםייתעשוא .

ףיחרת - שי ואםעלוטיל אלל לכוא .

הקנהוןוירה

הפורתבשמתשהלןיא לופיטהתלחתהינפלאפורבץעוויהלילבמ םא ימואןוירהבךניה הקינ , הלואןוירהלסנכיהלתננכתמ קינ .

3 . תבשמתשתדציכ הפור ?

וארוהיפלשמתשהלשידימת אפורהת !

דבלבאפורהידילעועבקילופיטהןפואוןונימ .

ליגלתחתמתוקוניתוםידלילללכךרדבתדעוימהניאוזהפורת 6 םישדוח .

תוסומכ : מתוחפםילקושהםידלילהסומכתתלןיא - 45 ק " ג .

ףיחרת : קרזמבואהדידמהתיפכבהנמהתדידמלעדיפקהלשי .

תחתמםילקושהםידליל ל - 15 ק " ג , קרזמבףיחרתהתאדודמלשי .

שומישהינפלףיחרתהתאבטיהרענלשי .

לעץלמוהשלופיטהתאםילשהלךילע - אפורהידי .

אפורםעתוצעייתהאללהפורתבלופיטהתאקיספהלןיאךתואירבבצמברופישלחםאםג .

תצלמומההנמהלערובעלןיא !

ןיא ןכותתארזפלוחותפל ה הסומכ , כמ ןווי הקדבנאלוזךרדבןתמהתעפשהש .

בלםיש !

הצמוחירתוסתליטנןיבלהפורתהתליטנןיבתוחפלםייתעשלשןמזקרפתוכחלשי .

הפורתהןמדליעלבתועטבםאוארתיתנמתלטנםא , ךתיאהפורתהתזיראאבהוםילוחתיבלשןוימרדחלדיימהנפ .

ןמזבוזהפורתלוטילתחכשםא שורדה תרכזנשכדימהנמלוטילשי , הלופכהנמלוטילןיאןפואםושבךא !

אפורהידילעץלמוהשיפכלופיטבדימתהלשי .

ךשוחבתופורתלוטילןיא ! לשי הנמהותיוותהקודב םעפלכב הפורתלטונךניהש . לשי כרה י םהלקוקזךניהםאםייפקשמב .

הפורתבשומישלעגונבתופסונתולאשךלשיםא , ה י חקורבואאפורבץעוו .

4 . יאוולתועפות

ומכ ב הפורתלכ , בשומישה הפורת םישמתשמהמקלחביאוולתועפותלםורגללולע . יתלא יאוולהתועפותתמישרארקמללהב ,

ןהמתחאףאמלובסתאלוןכתי .

י ש ושומישהתאקיספהל אפורלדימתונפל לשהרקמב :

תיגרלאהבוגת ) החירפתללוכה , פבתקצב םייפגבואםינ , הזחבבאכ , תוירועתובוגת ( ) רידנ (

לשהרקמבאפורלדימתונפלשי :

בלתוקיפד , ריהמבלבצק , בלהבצקבםייוניש , םדהתריפסבםייוניש , דבכידוקפתבםייוניש , דבכבתקלד , תבהצ , ףירחלושלש ,

בלבלבתקלד , תוילכבתקלד ) רידנ ( .

יאוולתועפות ה ובורקםיתיעלתועיפומ ת ) דעלשתוחיכש 1:100 (

לושלש , הליחב , ו / תואקהוא , ןטבבאכ , ןטבבתויוצווכתה , לוכיעתוערפה , תוחיפנ , היספפסיד , שארבאכ , תרוחרחס

תיללכהשלוח , תופייע , ןובאתרסוח , י השוחתבהדיר , היארבםייוניש , א ו העימשןדב , דרג , תוירועתובוגת , םיקרפבאכ ,

קיתרנבתקלד .

יאוולתועפות תופסונ תוקוחרםיתיעלתועיפומה ) ןיב 1:100 ל - 1:1000 (

שמשהרואלתושיגר , חירהואםעטהשוחבםייוניש , טקשרסוח , תונבצע , העימשבהדירי , םיינזואבםילוצלצ , תוריצע , תוינונשי ,

הנישיישק .

תופסוניאוולתועפות םיתיעלתועיפומה תורידנ ) ןיב 1:1000 ל - 1:10000 (

רורחס ) גיטרו ו ( , הדרח , קאבםייוניש " ג ) ןמזתכראה QT ( תירדחבצקתערפה ) האופהדהסרוט (

Azenilcapsules&suspension,17 Mar2013

תופסוניאוולתועפות העודיאלתוחיכשב :

רפיה - תויביטקא , ןושלהעבצביוניש , דהתויסטרפסמבהדירי ם , הילינומתלחמ ) תרטפ ( , תונפקות , םדץחלתת , ןופלע .

םידליבתויתפורתןיבתובוגתויאוולתועפות תוקוניתבו :

דלילתנתינהתפסונהפורתלכלעןכויאוולתועפותלכלעלפטמהאפורלחוודלםירוההלע / ה !

- הרימחמיאוולהתועפותמתחאםא , וא התארשאכ ןולעבהרכזוהאלשיאוולתעפותמלבוס , אפורהםעץעייתהלךילע .

5 . הפורתהתאןסחאלךיא ?

תוסומכהתארומשלשי ףיחרתהו ) ינפל לוהימה ( לתחתמ - C ° 25 .

ןכומהףיחרתהתארומשלשי ) לוהימהירחא ( לתחתמ - C ° 25 ךותובשמתשהלו 5 םימי .

הלערהענמ ! וםידלילשםדיגשיהלץוחמרוגסםוקמברומשלשיתרחאהפורתלכווזהפורת / ענמתךכידילעותוקוניתוא

הלערה . םורגתלא אפורהמתשרופמהארוהאללהאקהל .

ןיא הגופתהךיראתירחאהפורתבשמתשהל ) (exp. date הזיראהיבגלעעיפומה . לשןורחאהםוילסחייתמהגופתהךיראת

שדוחותוא .

6 . ףסונעדימ

םגהליכמהפורתהליעפהרמוחהלעףסונ :

תוסומכ :

Anhydrous Lactose,MaizeStarch,MagnesiumStearate,SodiumLaurylSulphate,Gelatin,TitaniumOxide

ףיחרת :

Sucrose,SodiumPhosphate tribasic Anhydrous,HydroxypropylCellulose,XanthanGum,artificial flavors:

Cherry,crèmedeVanilla andBanana.

תוסומכלינזא זוטקלליכמ :

הליכמהסומכלכ 151.55 מ " ג זוטקל .

ףיחרתלינזא ליכמ רכוס :

לכ 5 מ " ל םיליכמףיחרת 3.87 רכוסםרג .

ארנדציכ י הזיראהןכותהמוהפורתהת :

תוסומכלינזא : ןבלעבצבהסומכ םילימהםע " FIZER P " ו/ וא " ZTM 250 " רוחשבתועבטומ .

ףיחרתלינזא : ןבלעבצבהקבא - טיוופוא .

םושירהלעב : עבלארשיהקיטבצמרפרזייפ " מ , רקנש 9 , חותיפהילצרה 46725 .

הםש ןרצי : הניטלהמראפטפוה S.r.l , הילטיא

ערשואוקדבנהזןולע " ךיראתבתואירבהדרשמי : 17/03/2013

קנפבהפורתהםושיררפסמ תואירבהדרשמביתכלממהתופורתהס :

תוסומכלינזא : 117.66.29827.00

ףיחרתלינזא : 118.26.29828.00

האירקהתלקהלותוטשפהםשל , רכזןושלבחסונהזןולע . תאזלעףא , םינימהינשינבלתדעוימהפורתה .

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Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

29-3-2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

As of 23 April 2007, the reimbursement status of lipid lowering medicinal products will be changed. The decision includes all lipid lowering medicinal products with marketing authorisations in Denmark on 15 March 2007.

Danish Medicines Agency

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

18-4-2018

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (Active substance: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo) - Orphan designation - Commission Decision (2018)2405 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/246/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1893 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/222/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1892 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/217/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Soligenix UK Ltd)

EU/3/18/2001 (Active substance: Recombinant modified ricin toxin A-chain subunit) - Orphan designation - Commission Decision (2018)1889 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/242/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1894 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/234/17

Europe -DG Health and Food Safety