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

1986 - )تارضحتسم( ةلدايصلا ةمظنأ بجوبم كلهتسملل ةرشن

.رمعلا نم ةنس 12-4 ينب لافطلأ ءاطعلإا دنع ةيبط ةفصو مزلُي ءاودلا اذه

ءاودلا لامعتسا لبق ناعمإب اهلماكب ةرشنلا يئ/أرقإ

2011  لولأا نيرشت يف اهلبق نم ّرقُأو 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 مغلم 127 ىلع ةلوسبك لك يوتتح

:ةيبطلا ةيلاعفلا

.دالحا لاهسلإا جلاعل صصخم ءاودلا

.تانويفأ :ةينلاديصلا ةعومجلما

؟رضحتسلما لامعتسا عن ُميم ىتم

.ةعضرم تنك اذإ رضحتسلما يلمعتست لا

.رمعلا نم تاونس 4 نود لافطأ لبق نم لامعتسلاا عن ُي

.ةيلاعلا ةنوخسلا ةلاح يف وأ زاربلا يف مد دوجو ةلاح يف لامعتسلاا عن ُي

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

.ءاودلا تابكرم دحلأ ةيساسح كانه تناك اذإ ءاودلا لامعتسا عن ُي

:جلاعلا ةيادب لبق بيبطلا ةراشتسا نودب ءاودلا لامعتسا عن ُميم    

 .ًلاماح تنك اذإ

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

؟ةيمويلا كتايح ىلع ءاودلا رثؤي فيك

 ةيلاـعف ةيأ ةسرامـم دنعو ةرطخ تانكام ليغشت ،ةرايسلا ةقايس دنع سارتحلاا بجي كلذل .ساعنلا وأ راودلا ،بعتلا اًنايحأ مويدويإ ةطساوب لاهسلإا جلاع بّبسي دق

.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 .ةعاس 24 للاخ 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

 .ريقاقعلا ينب تلاعافتلا نع ةمجانلا ةعاجنلا مدـعو راـطخلأا يدافتل ،بيبطلا ةعجارم كيلعف ،رخآ ءاود يطاعت نم اًرخؤم تيهتنا وأ ،رخآ ءاود ينطاعتت/ىطاعتت تنك اذإ

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

 :ةيبناج ضارعأ

 مدعب روعش ،نطبلا يف ملأ .راودو بعت ،ساعن ،تاؤيقتو نايثغ ،مفلا يف فافج :لثم ةيبنالجا ضارعلأا هلامعتسا ءانثأ رهظت دق ،ءاودلل ةبوغرلما ةيلاعفلا ىلا ةفاضلإاب

.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 تلاوسبك 8 نم رثكأ لوانت  زوجي لا .لئاس زّربت لك دعب ةدحاو ةلوسبك كلذ دعبو ةيادبلا دنع ينتلوسبك :رابكلل

 .اهب ىصولما ةعرلجا ي/زواجتت لا

.4 نس نود عضرلاو لافطلأل ا ًصصخم سيل ءاودلا اذه

 .ةيبط ةبقارمو بيبط ةفصو مزلي ةنس 12-4 رامعلأا ينب لافطلأ ءاودلا ءاطعإ

.ةعاس 24 للاخ تلاوسبك 8 نم رثكأ لوانت عونمم .لئاس زّربت لك دعب ةدحاو ةلوسبك كلذ دعبو ةيادبلا دنع ةدحاو ةلوسبك :تاونس 5 قوف ام لافطلأا

 مويلا يف ىصقلأا تلاوسبكلا ددع   مغكب ة/لفطلا نزو  

                   مويلا يف تلاوسبك 3 نم رثكأ لا     مغك 20  

                   مويلا يف تلاوسبك 4 نم رثكأ لا     مغك 27  

مويلا يف تلاوسبك 5 نم رثكأ لا     مغك 34  

مويلا يف تلاوسبك 6 نم رثكأ لا     مغك 40  

مويلا يف تلاوسبك 7 نم رثكأ لا     مغك 47  

مويلا يف تلاوسبك 8 نم رثكأ لا     مغك 54  

.بيبطلا ةعجارم بجي ،ةنوخس رّوطت لاح يف وأ ،ةعاس 24 نم رثكلأ لاهسلإا رارمتسا لاح يف

.مويدويإ لوانت فاقيإ كيلعف ،ةعاس 24 للاخ 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 - ا ًضيأ لاهسلإا بابسأ ةلجاعم بجي .هثودح ىلا تّدأ يتلا بابسلأا جلاعي لا هنكل لاهسلإا فقوي ءاودلا اذه

 ىدل ًةصاخ اًيرورض نوكي رملأا اذه .فافلجا ثودح عنمو كمسلج لئاوسلا ةداعتسا لجأ نم برشلا نم راثكلإا بجي .لئاوسلاب ديدش نادقف ىلا يّدؤي لاهسلإا نإ

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

!ممستلا ي/عنمإ

 ءاودلا نم دلو علتبا اذإ وأ ةدئاز ةعرج تلوانت اذإ .مّمستب مهتباصإ يدافتل عضر وا/و لافطأ يديأ لوانتم نع اًديعب قلغم ناكم يف رخآ ءاود يأو ءاودلا اذه ظفح بجي

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

.كفراعم وأ كناريج ،كبراقلأ ءاودلا ءاطعإ عني .رخآ ا ًضيرم ّرضي دقو تنا كضرم ةلجاعلم فصو ءاودلا اذه !بيبطلا نم ةحضاو تاميلعت نودب ؤيقتلا بّبست عن ُي

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

.ةيوئم ةجرد 30-15 ينب :نيزختلا

 نم ةلاح ةيأ يف !ءاودلا ةيلحاص ةدم ءاهتنا خيرات ىلا هابتنلاا ىجري .ةليوط ةدلم ةلحاص ىقبت لا ةيودلأا نإف ،اهب ىصولما نيزختلاو ةئبعتلا تاميلعت ةاعارم دنع ىتح

.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?

Although Imodium stops diarrhea, it does not treat the cause of it. Whenever possible, the cause of the diarrhea should also be treated.

Diarrhea causes excessive loss of fluids. You should drink plenty of liquids to replace the fluid loss and avoid dehydration. This is 

especially important for small children. The pharmacist can supply a powder containing sugar and salts, which when reconstituted 

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

Avoid poisoning!

In order to avoid poisoning, this medicine and all other medicines must be stored in a safe place out of the reach of children and/

or infants. If you have taken an overdose, or if a child has accidentally swallowed the medicine, proceed immediately to a hospital 

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

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

This medicine has been prescribed for the treatment of your ailment; in another patient it may cause harm. Do not give this medicine 

to your relatives, neighbours or acquaintances.

Do not take medicines in the dark! Check the label and the dose each time you take your medicine. Wear glasses if you need them.

Storage:

15° - 30°C.

Even if kept in their original container and stored as recommended, medicines may be kept for a limited period only. Please note 

the expiry date of the medicine! In case of doubt, consult the pharmacist who dispensed the medicine to you. Do not store different 

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 IN ACCORDANCE 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.

Do not use this medicine if you should avoid slowing of intestinal motility, e.g. if you suffer from constipation or bloated abdomen.

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?

Sometimes treatment of diarrhea with Imodium may cause tiredness, dizziness or drowsiness; therefore, caution should be exercised 

when engaging in activities such as driving a car, operating dangerous machinery, and in any other activity which requires alertness. 

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.

Patients  with AIDS  being  treated  with  Imodium  should  stop  treatment  and  notify  the  doctor  immediately  if  they  have  signs  of 

abdominal bloating or bulging.

If  you  are  sensitive  to  any  type  of  food  or  medicine,  inform  your  doctor  before  commencing  treatment  with  this  medicine. The 

capsules contain Lactose.

Drug interactions:

If you are taking another drug concomitantly or if you have just finished treatment with another medicine, inform the attending doctor, 

in order to prevent hazards or lack of efficacy arising from drug interactions. This is especially important for medicines that slow 

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

Side effects:

In addition to the desired effect of the medicine, adverse reactions may occur during the course of taking this medicine, for example: 

dryness of the mouth, nausea and vomiting, drowsiness, tiredness, dizziness, abdominal pain, gastrointestinal discomfort, 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.

Hypersensitivity to the preparation is rare. It is manifested by skin rash, itching, difficulty breathing or swelling of the face. If you 

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

Side effects as a result of overdosage: muscle stiffness, poor coordination of body movements, drowsiness, difficulty urinating, 

difficulty breathing or weak breathing.

In the event that you experience side effects not mentioned in this insert, or if there is a change in your general health, 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.

Children above 5 years of age: The initial dose is one capsule; an additional capsule is to be taken after each subsequent loose 

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:

Do not chew! The medication should be taken with water. Do not retain this medication in the mouth longer than the time required 

for swallowing.

   ME 20676 PIL NOV 11

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

16-5-2018

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.

FDA - U.S. Food and Drug Administration

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

21-5-2018

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Active substance: Ponatinib hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3141 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/212/14/T/02

Europe -DG Health and Food Safety

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety

21-3-2018

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Active substance: Clonidine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)1817 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/11/T/02

Europe -DG Health and Food Safety