إيموديوم كبسولات

المعلومات الرئيسية

  • اسم تجاري:
  • إيموديوم كبسولات
  • الشكل الصيدلاني:
  • CAPSULES
  • طريقة التعاطي:
  • PER OS
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • JANSSEN CILAG S.A., FRANCE

المستندات

الأقلمة

  • متاح في:
  • إيموديوم كبسولات
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • ANTIPROPULSIVES
  • الخصائص العلاجية:
  • Control and symptomatic relief of acute diarrhea.

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 25102067600
  • تاريخ الترخيص:
  • 01-10-2011
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة: نشرة المعلومات, خصائص المنتج

1986- )تارضحتسم( ةلدايصلا ةمظنأ بجوبم كلهتسملل ةرشن

.رمعلا نم ةنس12-4 ينب لافطلأ ءاطعلإا دنع ةيبط ةفصو مزلُي ءاودلا اذه

ءاودلا لامعتسا لبق ناعمإب اهلماكب ةرشنلا يئ/أرقإ

2011 لولأا نيرشت يف اهلبق نمّرقُأو اهنومضم صحُفو ةحصلا ةرازو لبق نم ةرشنلا هذه ةغيص تدّدُح

مويدويمإ

تلاوسبك

:بيكرتلا

Loperamide Hydrochloride 2mg :اهتيمكو ةلاعفلا داولما

Lactose monohydrate, Maize starch,Talc, Magnesium stearate, Hard gelatine capsule :ةلاعفلا ريغ داولما

.تارديهونوم زوتكل مغلم127ىلع ةلوسبك لك يوتتح

:ةيبطلا ةيلاعفلا

.دالحا لاهسلإا جلاعل صصخم ءاودلا

.تانويفأ:ةينلاديصلا ةعومجلما

؟رضحتسلما لامعتسا عنُميمىتم

.ةعضرم تنك اذإ رضحتسلما يلمعتست لا

.رمعلا نم تاونس4نود لافطأ لبق نم لامعتسلاا عنُي

.ةيلاعلا ةنوخسلا ةلاح يف وأ زاربلا يف مد دوجو ةلاح يف لامعتسلاا عنُي

.خَفتنلما نطبلا وأ كاسملإا نم ني/يناعت تنك اذإًلاثم ،ءاعملأا طاشن ءاطبإ نع عانتملااب ة/مزلم تنك اذإ رضحتسلما لامعتسا عنُي

.ءاودلا تابكرم دحلأ ةيساسح كانه تناك اذإ ءاودلا لامعتسا عنُي

:جلاعلا ةيادب لبق بيبطلا ةراشتسا نودب ءاودلا لامعتسا عنُميم

.ًلاماح تنك اذإ

.دبكلا ةفيظو يف للخ نم اًقباس تيناع وأ ني/يناعت تنك اذإ

؟ةيمويلا كتايح ىلع ءاودلا رثؤي فيك

ةيلاـعفةيأةسرامـمدنعوةرطختانكامليغشت،ةرايسلاةقايسدنعسارتحلاابجيكلذل.ساعنلاوأراودلا،بعتلااًنايحأمويدويإةطساوبلاهسلإاجلاعبّبسيدق

.خلا عراشلا نم ةبرقم ىلع بعللا وأ ةجاردلا بوكر نم مهريذتح بجي ،لافطلأل ةبسنلاب .ةظـقيلا مزلت

:تاريذتح

.بيبطلا ةعجارمو ءاودلا لوانت فاقيإ كيلعف ،لاهسلإا فقو مدع لاح يف نكلو .ةعاس24للاخ لاهسلإا مويدويإ فقوي فوس

.اًروف بيبطلا ملاعإو ءاودلاب جلاعلا فاقيإ بجيف ،نطبلا يف ءوتنلا وأ خافتنلاا ةلاح يفف ،مويدويإ نولوانتي نيذلا زديلإا ىضرلم ةبسنلاب

.ءاودلا لوانت لبق اهنع كبيبط ملاعإ كيلعف ،ريقاقعلا وأ ماعطلا نم عونل ةيساسح ةيأ كيدل تناك اذإ

.زوتكل ىلع يوتتح تلاوسبكلا

:ىرخلأا ريقاقعلا عم تلاعافت

.ريقاقعلاينبتلاعافتلانعةمجانلاةعاجنلامدـعوراـطخلأايدافتل،بيبطلاةعجارمكيلعف،رخآءاوديطاعتنماًرخؤمتيهتناوأ،رخآءاودينطاعتت/ىطاعتتتنكاذإ

.ينلوكلا زارفلإ ةداضم ةيودأ ءاعملأا وأ ةدعلما طاشن ةريتو ئّطبت ةيودأب قلعتي اميف ةصاخ ةروصبو

:ةيبناج ضارعأ

مدعبروعش،نطبلايفملأ.راودوبعت،ساعن،تاؤيقتونايثغ،مفلايففافج:لثمةيبنالجاضارعلأاهلامعتساءانثأرهظتدق،ءاودللةبوغرلماةيلاعفلاىلاةفاضلإاب

.هسفن لاهسلإا نع ضارعلأا هذه مجنت دق .مضهلا زاهج يف تازاغو خافتنا ،ةحارلا

:صالخا هابتنلاا مزلت ةيبناج ضارعأ

.بيبطلا ةعجارم بجي - ةديدش ضارعلأا هذه تناك اذإ .جلاعلا نع فقوتلا بجي :لّوبتلا دنع ةبوعص ،نطبلا يف خافتنا،كاسمإ

.بيبطلا ي/عجار ضارعلأا هذه ىدحإب ني/رعشت تنك اذإ .هجولا يف خافتنا وأ سّفنتلا ةبوعص ،ةكح ،يدلج حفطب ىّلجتت ءاودلل ةردانو ةدئاز ةيساسح

.فيعض سّفنت وأ سّفنتلا يف ةـبوـعص ،لّوبتلا يف ةبوـعص ،ساعن ،مسلجا تاكرح يف قسانتلا ةلق ،تلاضعلا بّلصت :ةدئاز ةيئاود ةعرج ةجيتن ةيبناج ضارعأ

.اًروف بيبطلا ةراشتسا كيلعف ،ماعلا كروعش يف رييغت ثدح اذإ وأ ،ةرشنلا هده يف ركذت مل ةيبناج ضارعأب ترعش اذإ

:بيبطلا نم ىرخأ تاميلعت دوجو مدع لاح يف ةعبتلما ةيئاودلا ةعرلجا

.مويلا يف تلاوسبك8نم رثكأ لوانت زوجي لا .لئاس زّربت لك دعب ةدحاو ةلوسبك كلذ دعبو ةيادبلا دنع ينتلوسبك :رابكلل

.اهب ىصولما ةعرلجا ي/زواجتت لا

.4نس نود عضرلاو لافطلأل اًصصخم سيل ءاودلا اذه

.ةيبط ةبقارمو بيبط ةفصو مزلي ةنس12-4رامعلأا ينب لافطلأ ءاودلا ءاطعإ

.ةعاس24للاخ تلاوسبك8نم رثكأ لوانت عونمم .لئاس زّربت لك دعب ةدحاو ةلوسبك كلذ دعبو ةيادبلا دنع ةدحاو ةلوسبك :تاونس5قوف ام لافطلأا

مويلا يف ىصقلأا تلاوسبكلا ددع مغكب ة/لفطلا نزو

مويلا يف تلاوسبك3نم رثكأ لا مغك20

مويلا يف تلاوسبك4نم رثكأ لا مغك27

مويلا يف تلاوسبك5نم رثكأ لا مغك34

مويلا يف تلاوسبك6نم رثكأ لا مغك40

مويلا يف تلاوسبك7نم رثكأ لا مغك47

مويلا يف تلاوسبك8نم رثكأ لا مغك54

.بيبطلا ةعجارم بجي ،ةنوخس رّوطت لاح يف وأ ،ةعاس24نم رثكلأ لاهسلإا رارمتسا لاح يف

.مويدويإ لوانت فاقيإ كيلعف ،ةعاس24للاخ زّربت يأ كانه نكي مل اذإ وأ اًبلص زاربلا حبصأ اذإ

:لامعتسلاا ةقيرط

.ءالما عم ءاودلا علاتبا بجي !غضملل سيل

.هعلبل ةبولطلما كلت نع ديزت ةدلم مفلا يف ءاودلا ظافتحا عونمم

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

.اًنكمم رملأا نوكي امدنع - اًضيأ لاهسلإا بابسأ ةلجاعم بجي .هثودح ىلا تّدأ يتلا بابسلأا جلاعي لا هنكل لاهسلإا فقوي ءاودلا اذه

ىدلًةصاخاًيرورضنوكيرملأااذه.فافلجاثودحعنموكمسلجلئاوسلاةداعتسالجأنمبرشلانمراثكلإابجي.لئاوسلابديدشنادقفىلايّدؤيلاهسلإانإ

.لاهسلإا ءارج نم ةدوقفلما حلاملأا ةداعلإ هيلا ءالما ةفاضإ ىدل مدختسُي ،حلاملأاو ركسلا ىلع يوتحي قوحسبم كديوزت يلديصلا عيطتسي .راغصلا لافطلأا

!ممستلا ي/عنمإ

ءاودلانمدلوعلتبااذإوأةدئازةعرجتلوانتاذإ.مّمستبمهتباصإيدافتلعضروا/ولافطأيديألوانتمنعاًديعبقلغمناكميفرخآءاوديأوءاودلااذهظفحبجي

.ءاودلا هتوبع كعمو ،ىفشتسملل ئراوط ةفرغ ةعجارم كيلع ،اًوهس

.كفراعم وأ كناريج ،كبراقلأ ءاودلا ءاطعإ عني .رخآ اًضيرمّرضي دقو تنا كضرم ةلجاعلم فصو ءاودلا اذه !بيبطلا نم ةحضاو تاميلعت نودب ؤيقتلا بّبست عنُي

.اهيلا ةجاحب تنك اذإ ةيبطلا تاراظنلا ي/لمعتسإ .ءاودلل لوانت يأ لبق ةعرلجا نم دكأتلاو ءاودلا ةعقر صحف بجي !ملاظلا يف ةيودأ لوانت عنُي

.ةيوئم ةجرد30-15ينب:نيزختلا

نمةلاحةيأيف!ءاودلاةيلحاصةدمءاهتناخيراتىلاهابتنلااىجري.ةليوطةدلمةلحاصىقبتلاةيودلأانإف،اهبىصولمانيزختلاوةئبعتلاتاميلعتةاعارمدنعىتح

.ءاعولا سفن يف ىرخأ ةيودأ عم ءاودلا طلخ عني.ءاودلا اذه كل فرص يذلا يلديصلا ةراشتسا كيلع ،كشلا

025.10.20676:ءاودلا ليجست مقر

.اسنرف ،اور يد لاڤ ،چلايس نسناي:جتنلما

How can you contribute to the success of the treatment?

AlthoughImodiumstopsdiarrhea,itdoesnottreatthecauseofit.Wheneverpossible,thecauseofthediarrheashouldalsobetreated.

Diarrheacausesexcessivelossoffluids.Youshoulddrinkplentyofliquidstoreplacethefluidlossandavoiddehydration.Thisis

especiallyimportantforsmallchildren.Thepharmacistcansupplyapowdercontainingsugarandsalts,whichwhenreconstituted

in water is used to replace the salts that were lost due to the diarrhea.

Avoid poisoning!

Inordertoavoidpoisoning,thismedicineandallothermedicinesmustbestoredinasafeplaceoutofthereachofchildrenand/

orinfants.Ifyouhavetakenanoverdose,orifachildhasaccidentallyswallowedthemedicine,proceedimmediatelytoahospital

emergency room and bring the package of the medicine with you.

Do not induce vomiting unless explicitly instructed to do so by a doctor!

Thismedicinehasbeenprescribedforthetreatmentofyourailment;inanotherpatientitmaycauseharm.Donotgivethismedicine

to your relatives, neighbours or acquaintances.

Donottakemedicinesinthedark!Checkthelabelandthedoseeachtimeyoutakeyourmedicine.Wearglassesifyouneedthem.

Storage:

15° - 30°C.

Evenifkeptintheiroriginalcontainerandstoredasrecommended,medicinesmaybekeptforalimitedperiodonly.Pleasenote

theexpirydateofthemedicine!Incaseofdoubt,consultthepharmacistwhodispensedthemedicinetoyou.Donotstoredifferent

medications in the same package.

Drug Reg. No.:025.10.20676

Manufacturer:Janssen Cilag, Val de Reuil, France.

License holder:J-C Health Care Ltd., Kibbutz Shefayim 60990, Israel.

PATIENT PACKAGE INSERT INACCORDANCE WITH THE PHARMACISTS’REGULATIONS (PREPARATIONS) - 1986

This medicine must be prescribed in children aged 4-12 years.

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 - October 2011

Imodium ®

Capsules

Composition:

Each capsule contains: Loperamide hydrochloride 2 mg

Inactive ingredients:Lactose monohydrate, Maize starch,Talc, Magnesium stearate, Hard gelatine capsule.

Each capsule contains Lactose monohydrate 127 mg.

Therapeutic activity:

This medicine is indicated for the treatment of acute diarrhea.

Therapeutic group:Opioids.

When should the preparation not be used?

Do not use this medicine if you are breastfeeding.

Do not use this medicine in children below 4 years of age.

Do not use this medicine if there is blood in the stools or if you have high fever.

Donotusethismedicineifyoushouldavoidslowingofintestinalmotility,e.g.ifyousufferfromconstipationorbloatedabdomen.

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

Do not take this medicine without consulting a doctor before starting treatment:

If you are pregnant;

If you are suffering, or have suffered in the past, from impaired liver function.

How will this medicine affect your daily life?

SometimestreatmentofdiarrheawithImodiummaycausetiredness,dizzinessordrowsiness;therefore,cautionshouldbeexercised

whenengaginginactivitiessuchasdrivingacar,operatingdangerousmachinery,andinanyotheractivitywhichrequiresalertness.

Children should be cautioned against engaging in activities such as bicycle riding, playing near roads and the like.

Warnings:

Usually Imodium stops the diarrhea within 24 hours. If the diarrhea continues - stop treatment and refer to your doctor.

PatientswithAIDSbeingtreatedwithImodiumshouldstoptreatmentandnotifythedoctorimmediatelyiftheyhavesignsof

abdominal bloating or bulging.

Ifyouaresensitivetoanytypeoffoodormedicine,informyourdoctorbeforecommencingtreatmentwiththismedicine.The

capsules contain Lactose.

Drug interactions:

Ifyouaretakinganotherdrugconcomitantlyorifyouhavejustfinishedtreatmentwithanothermedicine,informtheattendingdoctor,

inordertopreventhazardsorlackofefficacyarisingfromdruginteractions.Thisisespeciallyimportantformedicinesthatslow

stomach or intestinal motility (e.g. anticholinergics).

Side effects:

Inadditiontothedesiredeffectofthemedicine,adversereactionsmayoccurduringthecourseoftakingthismedicine,forexample:

drynessofthemouth,nauseaandvomiting,drowsiness,tiredness,dizziness,abdominalpain,gastrointestinaldiscomfort,flatulence

and bloating.These effects can also be caused by diarrhea.

Effects that require special attention:

Constipation, bloating, difficulty urinating - stop the treatment. If these effects are severe, refer to your doctor.

Hypersensitivitytothepreparationisrare.Itismanifestedbyskinrash,itching,difficultybreathingorswellingoftheface.Ifyou

experience any of these side effects - refer to your doctor.

Sideeffectsasaresultofoverdosage:musclestiffness,poorcoordinationofbodymovements,drowsiness,difficultyurinating,

difficulty breathing or weak breathing.

Intheeventthatyouexperiencesideeffectsnotmentionedinthisinsert,orifthereisachangeinyourgeneralhealth,consult

your doctor immediately.

Recommended dosage unless otherwise prescribed by your doctor:

Adults:The initial dose is 2 capsules; and an additional capsule is to be taken after each subsequent loose stool.

Do not take more than 8 capsules in a 24 hour period.

Do not exceed the recommended dosage.

This medicine is not intended for administration to children and infants below 4 years of age.

Use of this medicine for children of 4-12 years of age requires a doctor’s prescription and medical supervision.

Childrenabove5yearsofage:Theinitialdoseisonecapsule;anadditionalcapsuleistobetakenaftereachsubsequentloose

stool. Do not take more than 8 capsules in a 24 hour period.

Child’s weight in kilograms Maximum number of the capsules per day

20 kg maximum 3 capsules per day

27 kg maximum 4 capsules per day

34 kg maximum 5 capsules per day

40 kg maximum 6 capsules per day

47 kg maximum 7 capsules per day

54 kg maximum 8 capsules per day

Consult a physician if the diarrhea continoues for more than 24 hours or if fever develops.

If stool becomes regulated or if more than 24 hours have passed without any stool, discontinue use.

Directions for use:

Donotchew!Themedicationshouldbetakenwithwater.Donotretainthismedicationinthemouthlongerthanthetimerequired

for swallowing.

ME 20676 PIL NOV 11

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 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

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Active substance: canagliflozin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)3463 of Wed, 30 May 2018

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety