مونتيلوكاست تيڤع ۱٠ ملغ

المعلومات الرئيسية

  • اسم تجاري:
  • مونتيلوكاست تيڤع ۱٠ ملغ
  • الشكل الصيدلاني:
  • TABLETS
  • طريقة التعاطي:
  • PER OS
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • TEVA PHARMACEUTICAL INDUSTRIES LTD

المستندات

الأقلمة

  • متاح في:
  • مونتيلوكاست تيڤع ۱٠ ملغ
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • MONTELUKAST
  • الخصائص العلاجية:
  • Montelukast Teva is indicated in adult and adolescents 15 years of age and older for the prophylaxis and chronic treatment of asthma including prevention of daytime and nighttime symptoms the treatment of aspirin-sensitive asthmatic patients and the prevention of exercise-induced bronchoconstriction. Montelukast Teva is effective alone or in combination with other agents used in the maintenance treatment of chronic asthma. Montelukast Teva and inhaled corticosteroids may be used concomitantly with additive effects to control asthma or to reduce the inhaled corticosteroid dose while maintaining clinical stability. Montelukast Teva is indicated for the relief of symptoms of seasonal allergic rhinitis in adults and adolescents 15 years of age and older.

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 140543155200
  • تاريخ الترخيص:
  • 01-04-2009
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة: نشرة المعلومات, خصائص المنتج

Montelukast Teva, 30.01.2012, SY

עעבקנהזןולעטמרופ " רשואוקדבנונכותותואירבהדרשמי

םיחקורהתונקתיפלןכרצלןולע ) םירישכת ( משתה " ו - 986 1

אפורםשרמבתבייחוזהפורת

ארק / שמתשתםרטבופוסדעןולעהתאןויעבי / הפורתבי

עבטטסאקולהטנומ ®

4 מ " ג 5 מ " ג 10 מ " ג

תוילבט הסיעל הסיעלתוילבט תוילבט

בכרה

הליכמהילבטלכ :

Montelukast 4 mg Montelukast 5mg Montelukast 10 mg

(as sodium salt) (as sodium salt) (as sodium salt)

םיליעפיתלבםיביכרמ :

טסאקולהטנומ עבט 4 מ " וג - 5 מ " ג הסיעלתוילבט :

Mannitol, sodium starch glycolate,hydroxypropyl cellulose, flavorcherry, magnesium stearate, sodium

laurilsulfate, ferric oxide red, aspartame.

טסאקולהטנומ עבט 4 מ " וג - 5 מ " הסיעלתוילבטג

בלםיש : טסאקולהטנומ עבט 4 מ " וג - 5 מ " הסיעלתוילבטג , ןינלאלינפלרוקמהווהמהםייטרפסאתוליכמ .

הליכמהילבטלכ 0.28 מ " ןינלאלינפג .

הליכמהילבטלכ 0.48-0.65 מ " ןרתנג .

טסאקולהטנומ עבט 10 מ " תוילבטג :

Lactose monohydrate, pregelatinized starch, sodium starch glycolate,hypromellose, titanium dioxide,

iron oxide yellow,iron oxide red, sodium laurilsulfate, hydroxypropyl cellulose, magnesium stearate.

טאסקולהטנומ עבט 10 מ " תוילבטג

הליכמהילבטלכ 128 מ " זוטקלג .

טלכ הליכמהילב 1-1.28 מ " ןרתנג .

תיטיופרתהצובק

קיוללםינטלוקימסוח טו ר םינאי .

םינאירטוקיול סלםיליבומרשאיתקלדךילהתלוהמישנהיכרדתרצהלםימרוגרשאםיימיכםירמוחםניה י לשםימוטפמ

המטסא . םינאירטוקיול סלםגםימרוג י םייגרלאםימוטפמ .

תיאופרתוליעפ

דעוימרישכתה תינורכהמטסאבלופיטל , סתעפוהתעינמתוברל י סתעפוהתעינמלוםויבוהלילבהלחמהינמ י ינמ

הלחמה מבקע םייתנשליגלעמםידליבוםירגובמבינפוגץמא .

סבהלקהלדעוימרישכתה י רלאתלזנלשםימוטפמ ג תי תיתנוע ובמב ג וםיר םייתנשליגלעמםידליב .

רישכתבשמתשהלןיאיתמ ?

ןיא היביכרממדחאלתושיגרהעודיםאוזהפורתבשמתשהל .

לופיטהתלחתהינפלאפורבץעוויהלילבמהפורתבשמתשהלןיא ןוירהבךניהםא וא הקינמ .

תורהזא

שיגרךניהםא / יהשלכהפורתלואוהשלכןוזמלה , הפורתהתליטנינפלאפורלךכלעעידוהלךילע .

אקולהטנומ ס ט עבט 10 מ " תוילבטג - םישיגרהםישנאלצאהיגרלאלםורגללולעוזוטקלליכמרישכתה

זוטקלל .

לבוסךניהםא / כלעעידוהלךילעדבכהדוקפתביוקילמרבעבתלבסואת ך הפורתהתליטנינפלאפורל .

המטסאלשםידחםיפקתהבלופיטלדעוימוניארישכתה , מב הלאםירק , לפטמהאפורהתוארוהרחאבוקעלשי .

םירקמב םירידנ , ורימחהףאאלאופלחאלרשאםינימסתרפסמווחטסאקולהטנומבולפוטשםילוח . ולאםינימסת

וללכ :

הלחמ תעפשתייומד , החירפ , םיילגרבואםיידיבתוהקתשוחתואהכיסתוריקדמומכםיצוצקעתשוחת , ישק י רצוקוא

המישנ , הפירחתקלד ) תוחיפנובאכ ( םיסוניסב ) סיטיסוניס ( . מסת דבועיפוהולאםיני " כ , דימתאלךא , ולטנרשאםילוחב

המטסאבלופיטלהפהךרדתוידיאורטסתופורת קספוהואתויטיאבתחפוהתוידיאורטסהתופורתהלשןנונימרשאכ .

כוהאלשתורמל ח טנומש ה םינימסתהמרתויואדחאעיפומםאדימאפורלתונפלשיולאםינימסתלםורגללולעטסאקול

וצמה םיניי הלעמל .

ןיבתובוגת - תויתפורת

לטונךניהםא / תפסונהפורתת , אפורםשרמאללהשכרנשהפורתתוברל , תרחאהפורתבלופיטההתעהזתרמגםאוא

ךילע

יאואםינוכיסעונמלידכלפטמהאפורלחוודל - ןיבתובוגתמםיעבונהתוליעי - דחוימבתויתפורת , המטסאדגנתופורתיבגל

חרמןוגכ סיבי י תונופמ , הפהךרדהליטנבואהפיאשבםידיאורטס , לטיברבונפ ) היספליפאבלופיטל ( , ןיציפמאפיר .

2

Montelukast Teva, 30.01.2012, SY

יאוולתועפות

ןוגכיאוולתועפשהעיפוהלתולולעהבשומישהןמזבהפורתהלשהיוצרהתוליעפלףסונב : ןטביבאכ , שארבאכ , לושליש ,

החירפודרגמוישקשקרוע , ןואמצתשוחת , ה י פ יביטקאר ו ת , המטסא .

תועפות יאוול ולא , ךרדבויה - תולקללכ , טנומבולפוטשםילוחבןתורידתו ה םילוחבוזלההזהתיהטסאקול ולפוטש

ובצלפב ") ובניא " - הפורתהליכמהניארשאהילבט רדבתשמשמה " כ תושדחתופורתתוליעיתקידבלםייוסינב ( .

טנומםעשומישבןהםגוחוודתואבהיאוולהתועפות ה טסאקול :

היגרלאתועפות ה םינפהתוחפנתהתוללוכ , םייתפשה , וןושלה / ןורגהוא , והמישנבםיישקלםורגלתולולעה / העילבבוא ,

תלרח ) רועבתדרגמהחירפ ( , רועביוריגואהחירפ , תויזהוהמילחתוערפה , םונמנ , תונזגר , היצטיגא ) רסוח החונמ , יא

קש ט (

תיביסרגאתוגהנתהללוכ , הנישידודנ , תוריקדתשגרה תוכיסוםיטחמ / השוחתרסוח , תויוצווכתהתורידנםיתיעל , הליחב ,

האקה , לוכיעבתוערפה , לושלש , סיטיטפה , םיקרפמיבאכ , רשתותיוועוםירירשיבאכ י םיר , םומידלתרבגומהייטנ ,

םילזונתריצעבקעתוחיפנלותולבחל , בלתוקיפד .

חתפמךניהוהדימבךלשאפורלחוודלשי / םהשלכםיליגריתלבםימוטפמיסת , ךשמתמוהשלכרכומםוטפמיסוהדימבוא

רימחמוא .

שיגרמךניהובשהרקמלכב / הזןולעבונייוצאלשיאוולתועפותה , תיללכהךתשגרהביונישלחםאוא , ץעייתהלךילע

םע

אפורה דימ .

וולתועפות תוקוניתבוםידליבתויתפורתןיבתובוגתויא

דלילתנתינהתפסונהפורתלכלעןכויאוולתועפותלכלעלפטמהאפורלחוודלםירוההלע / ה .

האר / וטרופשתודחוימתויתפורתןיבתובוגתויאוולתועפותליעלי .

ןונימ

דבלבאפורהתוארוהיפלןונימ .

תצלמומההנמהלערובעלןיא .

טילשי לו עבטטסאקולהטנומ אפורהתוארוהיפללכואהילבואםעםויבםעפ .

המטסאילוחב , תחקלשי םויבםעפעבטטסאקולהטנומ , ברעב .

תיתנועתיגרלאתלזנםעםילוחב , תחקלשי עבטטסאקולהטנומ אפורהתוארוהיפלםויבםעפ .

מתוחפךותבעבטטסאקולטנומלשתפסונהנמתחקלןיא - 24 מהמתועש תמדוקההנ .

ליגלתחתמתוקוניתוםידלילללכךרדבתדעוימהניאוזהפורת םייתנש .

ןמזבוזהפורתלוטילתחכשםא נש ק עב ןיא תרכזנשכדימהנמלוטיל ; החנהשיפכליגרההליטנהינמזחולבךישמהלשי

לפטמהאפורה .

המטסאלשםידחםיפקתהבלופיטלדעוימוניארישכתה , לשיהלאםירקמב לפטמהאפורהתוארוהרחאבוקע . ךילע

אדוול

עךלומשרנשהמטסאףקתהבלופיטלתודעוימהתופורתהש " לפטמהאפורהי , דיגשיהבדימתויהי .

בושח : המטסאהבצמלעהרקבברוזעלידכב , לוטילךישמהלשי עבטטסאקולהטנומ סרדעיהבםגוםויקבםג י םימוטפמ

לש עעבקנשןמזהקרפךשמלהמטסא " י לפטמהאפורה .

ךשמתמשומישבקרהמטסאבלופיטלדעוימעבטטסאקולהטנומ .

שומישהןפוא

עבטטסאקולהטנומ 4 מ " ג ו - 5 מ " הסיעלתוילבטג :

הילבטהתאסועללשי , החוראםערשקאללוםימטעמםע .

קנחלששחמםינטקםידלילתוילבטןתמבתוריהזהנשמטוקנלשי . לבבםישקתמהםידלירובע העי , תאקסרלץלמומ

הילבטה . רדחהתרוטרפמטבוארקןוזמבהאלמתיפכםעתקסורמההילבטהתאבברעלןתינ תידיימתתלו . אדוולשי

הנמהלכתאלבקמדליהש .

טסאקולהטנומ עבט 10 מ " תוילבטג :

סועללןיא , הילבטהתאתוצחלוא ! הילבטהתאעולבלשי , החוראםערשקאללוםימטעמםע .

******************************************

* לכותדציכ / לופיטהתחלצהלעייסלי ? *

*******************************************

עץלמוהשלופיטהתאםילשהלךילע " אפורהי .

אפורהםעתוצעייתהאללהפורתבלופיטהתאקיספהלןיאךתואירבבצמברופישלחםאםג .

ענמ / הלערהי !

וםידלילשםדיגשיהלץוחמרוגסםוקמברומשלשיתרחאהפורתלכווזהפורת / ענמתךכידילעותוקוניתוא / י הלערה .

הפורתהןמדליעלבתועטבםאוארתיתנמתלטנםא , הנפ / םילוחתיבלשןוימרדחלדימי , אבהו / ךתיאהפורתהתזיראי .

םורגתלא / י האקהל אפורהמתשרופמהארוהאלל !

ךתלחמבלופיטלהמשרנוזהפורת ; רחאהלוחב ) ת ( , קיזהלהלולעאיה .

ןתיתלא / י ךיבורקלוזהפורת , ךירכמואךינכש .

ךשוחבתופורתלוטילןיא ! קודב / הנמהותיוותהי םעפלכב לטונךניהש / ת הפורת . בכרה / ךניהםאםייפקשמי

קוקז / םהלה .

הנסחה

ורתרומשלשי הפ וז ךושחושביםוקמב , לתחתמ - º C 25 .

הזיראהיאנתיפלםג / םיצלמומההנסחה , דבלבתלבגומהפוקתלתורמשנתופורת . לשהגופתהךיראתלבלםישלאנ

3

Montelukast Teva, 30.01.2012, SY

רישכתה ! קפסלשהרקמלכב , הפורתהתאךלקפיסשחקורבץעוויהלךילע .

הזיראהתואבתונושתופורתןסחאלןיא .

סמ ' הפורתהםושיר

מ " ג : 140 55 31651 02 5 מ " ג : 140 56 31652 02

מ " ג : 140 54 31552 02

הםש ןרצי

Teva Operations Poland Sp. zo.o, Warsaw, Poland

םושירהלעב

עבןייטשלאוןיוולןומולס " מ , ת " ד 3696 הווקתחתפ .

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Olde York Potato Chips Issues Allergy Alert on Undeclared Milk in One Lot of Clancy's Wavy Potato Chips 10 Oz

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December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

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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

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Europe - EMA - European Medicines Agency

29-11-2018


Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Europe - EMA - European Medicines Agency

24-11-2018

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

22-11-2018


Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Europe - EMA - European Medicines Agency

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

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

12-7-2018

July 10, 2018: Pawtucket Woman Sentenced for Participation in Opioid Prescription Conspiracy

July 10, 2018: Pawtucket Woman Sentenced for Participation in Opioid Prescription Conspiracy

July 10, 2018: Pawtucket Woman Sentenced for Participation in Opioid Prescription Conspiracy

FDA - U.S. Food and Drug Administration

11-7-2018

July 10, 2018: VA Medical Center Nurse Indicted, Arraigned for Allegedly Tampering with and Stealing Prescription Opioids

July 10, 2018: VA Medical Center Nurse Indicted, Arraigned for Allegedly Tampering with and Stealing Prescription Opioids

July 10, 2018: VA Medical Center Nurse Indicted, Arraigned for Allegedly Tampering with and Stealing Prescription Opioids

FDA - U.S. Food and Drug Administration

11-7-2018

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

FDA - U.S. Food and Drug Administration

11-7-2018

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

FDA - U.S. Food and Drug Administration

6-6-2018

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

FDA - U.S. Food and Drug Administration

11-5-2018

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

FDA - U.S. Food and Drug Administration

10-5-2018

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

FDA - U.S. Food and Drug Administration

19-4-2018

March 30, 2018: Lynn Man Sentenced to Over 10 Years in Prison for Role in Counterfeit Steroid Conspiracy

March 30, 2018: Lynn Man Sentenced to Over 10 Years in Prison for Role in Counterfeit Steroid Conspiracy

March 30, 2018: Lynn Man Sentenced to Over 10 Years in Prison for Role in Counterfeit Steroid Conspiracy

FDA - U.S. Food and Drug Administration

11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

4-1-2019


Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Recommendations on eligibility to PRIME scheme -  Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Europe - EMA - European Medicines Agency

14-12-2018


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

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

22-11-2018


Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Europe - EMA - European Medicines Agency

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety

22-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/mNsFqKTfFk

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/WAPabvM811

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/YRV0lVSRkh

FDA - U.S. Food and Drug Administration

21-5-2018

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/GzY50eEVp9

FDA - U.S. Food and Drug Administration

18-5-2018

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Active substance: Cysteamine bitartrate (gastroresistant)) - Transfer of orphan designation - Commission Decision (2018)3137 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/034/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Active substance: Midostaurin) - Transfer of orphan designation - Commission Decision (2018)3039 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/016/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Active substance: Everolimus) - Transfer of orphan designation - Commission Decision (2018)3038 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety