دكترين كريم

المعلومات الرئيسية

  • اسم تجاري:
  • دكترين كريم
  • الشكل الصيدلاني:
  • CREAM
  • طريقة التعاطي:
  • DERMAL
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • JANSSEN PHARMACEUTICA N.V.,BELGIUM

المستندات

الأقلمة

  • متاح في:
  • دكترين كريم
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • MICONAZOLE
  • الخصائص العلاجية:
  • Broad spectrum antimycotic

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 48832411801
  • تاريخ الترخيص:
  • 01-11-2010
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة: نشرة المعلومات, خصائص المنتج

1986-ו"משתה )םירישכת( םיחקורה תונקת יפל ןכרצל ןולע

הפורתב י/שמתשת םרטב ופוס דע ןולעה תא ןויעב י/ארק

לע רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ

2012ראוניב ודי

TRADEMARK

םרק ןירטקד

Miconazole Nitrate 20 mg/g (2%) :בכרה

:םיליעפ יתלב םיביכרמ

PEG-6 (and) PEG-32 Stearate and Glycol Stearate, Oleoyl

Macrogolglycerides, Liquid Paraffin, Butylated Hydroxyanisole,

Benzoic Acid, Purified Water.

םייתירטפםימוהיזבלופיטלתדעוימהפורתה:תיאופרתוליעפ

.םיינוציח

?רישכתב שמתשהל ןיא יתמ

.הפורתה יביכרממ דחאל תושיגר ךל העודי םא שמתשהל ןיא

תלחתהינפלאפורבץעוויהלילבמהפורתבשמתשהלןיא

:לופיטה

.הקינימ וא ןוירהב ךניה םא

.םייניעה רוזאב םרקה לש עגממ ענמיהל שי:תורהזא

ענמיהלידכאפורבץעוויהליוצררישכתבינושארשומישינפל

הפורתלואוהשלכןוזמלה/שיגרךניהםא .ךרוצלאלששומישמ

.הפורתב שומישה ינפל אפורל ךכ לע עידוהל ךילע ,יהשלכ

ללוכ,תפסונהפורתת/לטונךניהםא:תויתפורת-ןיבתובוגת

התעהזתרמגםאוא,הנוזתיפסותוםשרמאללתורכמנהתופורת

עונמלידכלפטמהאפורלחוודלךילע,תרחאהפורתבלופיטה

.תויתפורת-ןיב תובוגתמ םיעבונה תוליעי-יא וא םינוכיס

שומישהןמזבהפורתהלשהיוצרהתוליעפלףסונב:יאוולתועפות

הריעבתשוחתואימוקמיוריגןוגכ,יאוולתועפותעיפוהלתולולעהב

.םימוטפמיסב הלקהל דע לופיטה תא י/קספה - הלק

תדחוימ תוסחייתה תובייחמה יאוול תועפות

:)רידנ(שומישהרחאלםיעיפומשלופיטהםוקמבתוימומדאודרג

ה/שיגרמךניהובשהרקמלכב .אפורלי/הנפולופיטהתאי/קספה

ךתשגרהביונישלחםאוא,הזןולעבונייוצאלשיאוולתועפות

.דימ אפורה םע ץעייתהל ךילע ,תיללכה

אפורמ תרחא הארוה רדעהב לבוקמ ןונימ

.תונידעבתוסעלועוגנהרוזאהלעםויבםיימעפ,םרקטעמחורמלשי

ללכ-ךרדב,םוהיזהלשתטלחומתומלעיהלדעךשמנלופיטה

ךישמהלשיםוהיזהתונשיהתעינמל.תועובשהשישדעםייעובש

.םוהיזה לש תטלחומה תומלעיהה רחאל םימי עובש לופיטב

.אפורהמתושרופמתוארוהיפ-לעאלאעוגנהרוזאהתאתוסכלןיא

.תצלמומה הנמה לע רובעל ןיא

ליגלתחתמתוקוניתוםידלילללכ-ךרדבתדעוימהניאוזהפורת

.אפור תארוה יפ לע אלא םייתנש

.אפורל תונפל שי םימי שדוח ךות ךבצמב רופיש לח אל םא

!בל י/םיש

.דבלב ינוציח שומישל תדעוימ וז הפורת!עולבל אל

.)ףאבו הפב ןוגכ( תויריר תומקר וא םייניע םע עגממ ענמיהל שי

לופיטהןכםאאלאםרקבשומישרחאלםיידיהתאבטיהףוטשלשי

.םיידיה רוזאל וניה

.הנושאר החיתפ רחאל םישדוח3דע רישכתב שמתשהל ןתינ

עוגנהרוזאהלע,םויבםיימעפ,םרקטעמחורמלשי:שומישהןפוא

,םוהיזהלשתטלחומתומלעיהלדעךשמנלופיטה.תונידעבתוסעלו

.תועובש השיש דע םייעובש ללכ-ךרדב

רחאלםימיעובשלופיטבךישמהלשיםוהיזהתונשיהתעינמל

אלאעוגנהרוזאהתאתוסכלןיא.םוהיזהלשתטלחומהתומלעיהה

.אפורהמ תושרופמ תוארוה פ"ע

?לופיטה תחלצהל עייסל י/לכות דציכ

שבוילערומשלשיןכל.תוירטיפהתחימצתאתדדועמתוחל

.עוגנה םוקמב

ושבילוהפורתהלשהחירמלכינפלעוגנהרוזאהתאץוחרלשי

.בטיה

.דבלב ישיאה ךשומישל הכימשו תבגמל י/גאד

עונמלידכעוגנהרוזאהםעעגמבםיאבהםידגבףילחהלי/גאד

םייברגבשמתשהליוצר-םיילגרבאוהלופיטהםא.תרזוחהקבדה

.תומיאתמה תונועב םייברג אלל םילדנס לוענלו הנתוכמ

!הלערה י/ענמ

גשיהלץוחמרוגסםוקמברומשלשיתרחאהפורתלכווזהפורת

.הלערה י/ענמת ךכ ידי לעו תוקונית וא/ו םידלי לש םדי

דימי/הנפ,הפורתהןמדליעלבתועטבםאוארתיתנמתלטנםא

.ךתיא הפורתה תזירא י/אבהו ,םילוח תיב לש ןוימ רדחל

!אפורהמ תשרופמ הארוה אללהאקהל םורגל ןיא

.קיזהלהלולעאיהת/רחאהלוחב,ךתלחמבלופיטלהמשרנוזהפורת

.ךירכמ וא ךינכש ,ךיבורקל וז הפורת י/ןתת לא

ךניהשםעפלכבהנמהותיוותהקודבלשי!ךשוחבתופורתלוטילןיא

.םהל ה/קוקז ךניה םא םייפקשמ ביכרהל שי .הפורת לטונ

ןיב רירק םוקמב ןסחא:הנסחא

הפוקתלתורמשנתופורת,םיצלמומההנסחה/הזיראהיאנתיפלםג

לכב!רישכתהלשהגופתהךיראתלבלםישלאנ.דבלבתלבגומ

ןיא.הפורתהתאךלקפיסשחקורבץעוויהלךילע,קפסלשהרקמ

.הזירא התואב תונוש תופורת ןסחאל

488324118:הפורתה םושיר 'סמ

.היגלב ,הסריב ,הקיטבצמרפ ןסני:ןרצי

:םושירה לעב

.לארשי ,60990םייפש ץוביק ,מ"עב רק'תלה יס-יי'ג

IL-980111

ةلديصلا ةمظنأ بجوبم كلهتسملل ةيبط ةرشن

1986)تارضحتسم(

ءاودلل كلامعتسإ لبق اهتياهن ىتح ناعمإب ةرشنلا ي/أرقإ

يف اهلبق نم صخُرو صحُف اهاوتحمو ةرشنلا هذه ةغيص ةحصلا ةرازو ترقأ

2012يناث نوناك

TRADEMARK

يمرك نيراتكد

Miconazole Nitrate 20 mg/g (2%) :بيكرتلا

:ةلاعفلا ريغ داولما

PEG-6 (and) PEG-32 Stearate and Glycol Stearate, Oleoyl

Macrogolglycerides, Liquid Paraffin, Butylated Hydroxyanisole,

BenzoicAcid, Purified Water.

ةيبطلا ءاودلا تاريثأت

.ةيجراخلا ةيرطفلا تاثولتلا ةجاعمل صصخم ءاودلا اذه

؟رضحتسملا لامعتسإ كل زوجي لا ىتم

.هتابكرم دحلأ ةيساسح كيدل تدجو اذإ رضحتسملا اذه لامعتسإ كل زوجيلا

:ًامدقم بيبطلا ةعجارم لبق ءاودلا اذه لامعتسإ كل زوجي لا

.ةعاضرلا ةرتف يف وأ لمحلا ةرتف يف نينوكت امدنع

.نينيعلا ةقطنمب ميركلا سامت نع عانتملإا بجي:تاريذحت

ريغلامعتسلإلًابنجت،بيبطلاةراشتسإهببوغرملانم،رضحتسملابيلولأالامعتسلإالبق

.ءاودلل كلامعتسإ لبق ريقاقع وأ ماعطل كيدل ةيساسح يأ نع بيبطلا غلابإ بجي .يرورضلا

ةفصونودبعابُتةيودأكلذيفامب،اًيفاضإًءاودن/ىطاعتتتنكاذإ:ةيودلأانيبتلاعافتلا

كلذو،جلاعملابيبطلاملاعإبجيف،رخآءاودبنلآاجلاعلاتيهنأاذإوأ،ماعطتافاضإوبيبط

.ريقاقعلا نيب تلاعافتلا نع ةجتانلا ةعاجنلا مدع وأ راطخلأا يدافتل

هلامعتسإةرتفءانثأرهظتدقف،ءاودللةبوغرملاةيبطلاتاريثأتلاىلإةفاضإ:ةيبناجلاضارعلأا

جلاعلانعي/فقوتـةفيفخةقرحبساسحلإاوأيعضوملاجيهتلاكةيبناجلاضارعلأاضعب

.ضارعلأا فيفختب روعشلا ىتح

ًاصاخًامامتهإ يضتقت يتلا ةيبناجلا ضارعلأا

جلاعلانعي/فقوت:)ًاردان(لامعتسلإادعبرهظتثيحجلاعلاناكميفرارمحإوةكح

يأأرطاذإوأ،ةرشنلاهذهيفركذتملةيبناجضارعأكيدلترهظاذإامأ.بيبطلاي/عجارو

.ًلااح بيبطلا ةعجارم ذئدنع كيلع،ءاودلا اذهل كلامعتسلإ ةجيتن ماعلا كروعش ىلع رييغت

بيبطلا نم ىرخأ تاميلعت دوجو مدع ةلاح يف ةيدايتعلإا ةيئاودلا ريداقملا

جلاعلارمتسي.فطلبهكيلدتومويلايفنيترم،باصملاناكملايفميركلانمليلقلانهدبجي

.عيباسأ6ىتح نيعوبسأ ةداع رملأا اذه رمتسيو مات لكشب ثولتلا ءافتخإ ىتح

ءافتخإدعبةيفاضإمايأ7جلاعلايفرارمتسلإابجيثولتلارركتعنملجأنمواذه

.ًامامت ثولتلا

.بيبطلا نم ةحيرص تاميلعتب لاإ ةباصملا ةقطنملا ةيطغت زوجي لا

.اهب ىصوملا ريداقملا ي/زواجتت لا

لاإنيتنسرمعنودعضرلاولافطلأاىدلةداعلامعتسلإلصّصخمريغءاودلااذه

.بيبط تاميلعت بسح

.رهش للاخ ةيحصلا كتلاح ىلع نسحت أرطي مل اذإ بيبطلا ةعجارم بجي

!ي/هبتنإ

.طقف يجراخلا لامعتسلإل صصخم ءاودلا اذه!علبلل سيل ءاودلا اذه

نيديلافطشبجي.)فنلأاومفلاك(ةيطاخملاةجسنلأا،نينيعلابءاودلاسامتنععانتملإابجي

.نيديلا ةقطنملًاصصخم جلاعلا ناك اذإ لاإ ميركلا لامعتسإ ءاهتنإبًاديج

.ةرم لولأ هحتف موي نم رهشأ3ىتح رضحتسملا لامعتسا زوجي

مويلايفنيترم،باصملاناكملايفميركلانمليلقلانهدبجي:لامعتسلإاتاداشرإ

ةداعرملأااذهرمتسيوماتلكشبثولتلاءافتخإىتحجلاعلارمتسي.فطلبهكيلدتو

.عيباسأ6ىتح نيعوبسأ

ثولتلاءافتخإدعبةيفاضإمايأ7جلاعلايفرارمتسلإابجيثولتلارركتعنملجأنمواذه

.بيبطلا نم ةحيرص تاميلعتب لاإ ةباصملا ةقطنملا ةيطغت زوجي لا .ًامامت

؟ جلاعلا حاجن يف ي/مهاست نأ ني/عيطتست فيك

ةقطنملاءاقبىلعةظفاحملابجياذل،تايرطفلاومنىلعةدعاسملالماوعلانمةبوطرلاربتعت

.ًاديج اهفيفجتو ءاودلاب ةنهد لك لبق ةباصملا ةقطنملا لسغ بجي .ةفاجةباصملا

ىلعصرحلابجيامك.طقفيصخشلاكلامعتسلإةيناطبوةفشنملامعتسإىلعصرحلابجي

.ىودعلا رركت بنجت ةيغب ةباصملا ةقطنملا عم سامتب يتلا بايثلا لادبتسإ

لدانصلاسبلوةينطقلابراوجلالامعتسإهببوغرملانمـنيمدقلاةقطنملجلاعلاناكاذإ

.ةمئلاملا مساوملا يف براوج نودب

!ممستلا ي/بنجت

،عضرلا وأ/و لافطلأا يديأ لوانتم نعًاديعب قلغم ناكم يف ءاود لكو ءاودلا اذه ظفح بجي

ة/لفطلاعلباذإوأةيئاودلاريداقملالامعتسإيفتطرفأاذإ.ممستلابمهتباصإيدافتلكلذو

.ءاودلا ةوبع ة/ًابحطصمًلااح ىفشتسملا ىلإ هجوتلا كيلع ،ءاودلا اذه نم أطخ

.بيبطلا نم ةحيرص تاميلعت نودبؤيقتلا ي/ببست لا

.رخآ ضيرمل ررضلا ببسي دقو ،كضرم جلاعل فصو ءاودلا اذه

.كفراعم وأ كناريج ،كبراقأ ىلإ ءاودلا نم ي/طعت لا

يفةيئاودلاريداقملانمدكأتلاوءاودلاعباطصيخشتبجي!ةمتعلايفءاودلاي/لوانتتلا

.كلذ رملأا مزل اذإ ةيبطلا تاراظنلا ي/عض .ءاود اهيف ني/لوانتتةرم لك

.ةيوئم ةجرد25-15نيب دراب ناكم يف :نيزختلا

اهظفحمتوةيلصلأااهتبلعيفتلظولوىتح،طقفةدودحمتارتفلةحلاصةيودلأاىقبت

ىلعةنودملارضحتسملاةيحلاصءاهتنإخيراتةظحلامءاجرلا.نزخلاتاميلعتبجومب

نيزختزوجيلا.ءاودلااذهكلفرصيذلايلديصلاةراشتسإكيلع!كشلاةلاحيف.ةوبعلا

.ةوبعلا سفن يف ةفلتخم ةيودأ

488324118:ءاودلا لجس مقر

.اكيجلب ،ةزريب ،اكيتوسامراف نسناي:جتنملا

،.ض.م ريك ثليه يس ـ ييج:ليجستلا بحاص

.ليئارسإ ،60990مييافش ستوبيك

PATIENT PACKAGE INSERT IN ACCORDANCE WITH

THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

Read this package insert carefully in its entirety

before using this medicine

The format of this leaflet was determined by the Ministry of Health

and its content was checked and approved in January 2012.

TRADEMARK Daktarin

Cream

COMPOSITION:Miconazole Nitrate 20 mg/g (2%)

Inactive ingredients:

PEG-6 (and) PEG-32 Stearate and Glycol Stearate, Oleoyl

Macrogolglycerides, Liquid Paraffin, Butylated Hydroxyanisole, Benzoic

Acid, Purified Water.

THERAPEUTIC ACTIVITY

This medicine is intended for the treatment of external fungal infections.

WHEN SHOULD THE PREPARATION NOT BE USED?

Do not use this medicine if you are sensitive to any of its ingredients.

Donotusethismedicinewithoutconsultingadoctorbeforestarting

treatment:

If you are pregnant or breastfeeding.

WARNINGS:Avoid contact of the cream with the eyes area.

Beforestartingtreatmentwiththepreparation,itispreferabletoconsult

a doctor in order to avoid unnecessary use.

Ifyouaresensitivetoanytypeoffoodormedicine,informyourdoctor

before commencing treatment with this medicine.

DRUGINTERACTIONS:Ifyouaretakinganotherdrugconcomitantly,

includingmedicinespurchasedwithoutaprescriptionandfoodadditives,

orifyouhavejustfinishedtreatmentwithanothermedicine,informthe

attendingdoctor,inordertopreventhazardsorlackofefficacyarising

from drug interactions.

SIDEEFFECTS:Inadditiontothedesiredeffectofthemedicine,adverse

reactionsmayoccurduringthecourseofusingthismedicine,suchas

localirritationoramildburningsensationoftheskin-stoptreatment

until symptoms are relieved.

Side effects that require special attention:

Itchingandrednessatthesiteoftreatmentwhichappearafteruse(rare):

stop treatment and refer to the doctor.

Intheeventthatyouexperiencesideeffectsnotmentionedinthisleaflet,orif

there is a change in your general health, consult your doctor immediately.

RECOMMENDED DOSAGE

UNLESS OTHERWISE DIRECTED BY THE DOCTOR:

Applyasmallamountofcream,twiceaday,ontheaffectedareaand

rubingently.Treatmentshouldbecontinueduntilthelesionshave

completely disappeared, usually after 2 to 6 weeks.

Topreventarelapse,continuetreatmentforafurtherweekafterthe

infection has disappeared completely.

Donotcovertheaffectedareaunlessexplicitlyinstructedtodosoby

a doctor.

Do not exceed the recommended dosage.

Thismedicineisnotusuallyintendedforadministrationtochildren

and infants under 2 years of age without a physician’s instructions.

Ifthereisnoimprovementinyourconditionwithin1month,referto

your doctor.

ATTENTION!Do not swallow!

This medicine is intended for external use only.

Avoidcontactwiththeeyesormucousmembranes(suchasinthe

mouth and nose).

Washyourhandsthoroughlyafterusingthecreamunlesstheinfection

being treated is on your hands.

The product can be used up to 3 months after first opening.

DIRECTIONSFORUSE:Applyasmallamountofcream,twiceaday,on

theaffectedareaandrubingently.Treatmentshouldbecontinueduntil

the lesions have completely disappeared, usually after 2 to 6 weeks.

Topreventarelapse,continuetreatmentforafurtherweekafterthe

infection has disappeared completely.

Donotcovertheaffectedareaunlessexplicitlyinstructedtodosoby

a doctor.

HOW CAN YOU CONTRIBUTE TO THE SUCCESS OF THE TREATMENT?

Dampnesspromotesfungalgrowth.Therefore,theaffectedareashould

be kept dry.

Theaffectedareamustbewashedanddriedthoroughlybeforeeach

application of the medicine.

Keep a towel and a blanket for your own use only.

Changeanyclotheswhichhavecomeincontactwiththeinfectedareain

order to prevent re-infection.

Whentreatingthefeet,itisadvisabletowearcottonsocksandduringthe

appropriate seasons, it is advisable to wear sandals without socks.

AVOID POISONING!

Thismedicine,andallothermedicines,mustbestoredinasafeplaceout

of the reach of children and/or infants, to avoid poisoning.

Ifyouhavetakenanoverdose,orifachildhasaccidentallyswallowedthe

medicine,proceedimmediatelytoahospitalemergencyroomandbring

the package of the medicine with you.

Donotinducevomitingunlessexplicitlyinstructedtodosobyadoctor!

Thismedicinehasbeenprescribedforthetreatmentofyourailment;in

anotherpatientitmaycauseharm.Donotgivethismedicinetoyour

relatives, neighbours or acquaintances.

Donottakemedicinesinthedark!Checkthelabelandthedoseeachtime

you take your medicine. Wear glasses if you need them.

STORAGE:Store in a cool place between 15°-25°C.

Evenifkeptintheiroriginalcontainerandstoredasrecommended,

medicinesmaybekeptforalimitedperiodonly.Pleasenotetheexpiry

dateofthemedicine!Incaseofdoubt,consultthepharmacistwho

dispensedthemedicinetoyou.Donotstoredifferentmedicationsin

the same package.

Drug Reg. No:488324118

Manufacturer:Janssen Pharmaceutica, Beerse, Belgium.

Registration Holder:J-C Health Care Ltd.,

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TRADEMARK

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IL-980111

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

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

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

Enforcement Report for the Week of November 21, 2018

Enforcement Report for the Week of November 21, 2018

Recently Updated Records for the Week of November 21, 2018 Last Modified Date: Tuesday, November 20, 2018

FDA - U.S. Food and Drug Administration

21-11-2018

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Published on: Tue, 20 Nov 2018 The goal of the current work was to implement and verify previously published rat and human PBPK modelling codes for TCDD into Berkeley Madonna. The US‐EPA has used these PBPK models in the reassessment of TCDD. A procurement contract has been set up to explore the possibilities to adequately run the models and reproduce previously published results. The implementation of the available codes in Berkeley Madonna was carried out at RIKILT‐WUR under the framework agreement wi...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

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

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

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

FDA - U.S. Food and Drug Administration

20-11-2018

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Op 20 november zijn de vijf winnaars van de Innovation Challenge Energieneutrale Sportaccommodaties, vanuit het programma Sportinnovator, bekendgemaakt. De innovatieve ideeën voor energiebesparing bij sportaccommodaties hebben groen licht gekregen. Ze ontvangen hiervoor steun van het ministerie van Volksgezondheid, Welzijn en Sport om innovatie in de sport te bevorderen. Onderstaande initiatieven krijgen 100.000 euro om het idee in de praktijk door te voeren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Theme event on big data and medicine

Theme event on big data and medicine

The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

Danish Medicines Agency

29-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

FDA - U.S. Food and Drug Administration

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

8-10-2018

Glyceryl trinitrate tablets (Anginine and Lycinate)

Glyceryl trinitrate tablets (Anginine and Lycinate)

Update 3 - continuing medicine shortage

Therapeutic Goods Administration - Australia

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

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

9-8-2018

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

Vita-Mix Corporation recalls Ascent and Venturist Series 8-ounce and 20-ounce Blending Containers

The container can separate from the blade base exposing the blades, posing a laceration hazard to consumers.

Health Canada

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

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency

23-8-2018

 Minutes of the CAT meeting 18-20 April 2018

Minutes of the CAT meeting 18-20 April 2018

Europe - EMA - European Medicines Agency

22-8-2018

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye:  http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz . pic.twitter.com/ecJErFeiSH

FDA - U.S. Food and Drug Administration

22-8-2018

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Active substance: fenofibrate / simvastatin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5632 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2559/T/20

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety