تريتايس كومب ٢٫٥ ملغم/١٢٫٥ ملغ

المعلومات الرئيسية

  • اسم تجاري:
  • تريتايس كومب ٢٫٥ ملغم/١٢٫٥ ملغ
  • الشكل الصيدلاني:
  • TABLETS
  • طريقة التعاطي:
  • PER OS
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • SANOFI - AVENTIS S.P.A., ITALY

المستندات

الأقلمة

  • متاح في:
  • تريتايس كومب ٢٫٥ ملغم/١٢٫٥ ملغ
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • RAMIPRIL AND DIURETICS
  • الخصائص العلاجية:
  • Essential hypertension. Tritace comp is indicated in patients whose blood pressure cannot be adequately lowered with ramipril alone.

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 122273018700
  • تاريخ الترخيص:
  • 01-04-2011
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986

The dispensing of this medicine requires a doctor's prescription

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 November 2010

TRITACE COMP  TRITACE COMP

2.5 mg/12.5 mg  5 mg/25 mg

Tablets  Tablets

Composition:

Each tablet contains:   Each tablet contains:

Ramipril  2.5 mg  Ramipril   5 mg

Hydrochlorothiazide 12.5 mg  Hydrochlorothiazide 25 mg

Inactive ingredients: Pregelatinized starch, Microcrystalline cellulose, Hydroxypropylmethylcellulose, Sodium stearyl fumarate.

Therapeutic group: ACE inhibitor + thiazide diuretic.

Therapeutic activity: For treatment of high blood pressure

When should the preparation not be used?

Do not use this preparation in the last six months of pregnancy or if you are breastfeeding.

Do not use if there is a known sensitivity to ramipril or to any other ACE inhibitor used to lower blood pressure or to hydrochlorothiazide 

or to other thiazide diuretics or to sulfonamides or to any ingredients of the medicine.

Do not use if you have ever had a severe allergic reaction called angioedema.

Do not use if you suffer from a problem in blood supply to the kidneys - renal artery stenosis.

Do not use if you are undergoing dialysis or any other type of blood filtration.

Do not use if you suffer from severe kidney function impairment.

Do not use if you suffer from severe liver function impairment.

Do not use if you suffer from disturbances in the level of salts, e.g.: low blood potassium or sodium or patients with hypercalcemia.

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

If you suffer from: heart, liver or kidney problems; loss of salts or fluids (as a result of vomiting, diarrhea, excessive sweating, low 

salt diet, taking diuretics for a prolonged period or if you have undergone dialysis); if you are about to undergo treatment to reduce 

allergy to bee or wasp stings (desensitization); if you are about to receive anesthetics for surgery or dental treatment; if your blood 

potassium level is high; if you suffer from connective tissue diseases such as scleroderma or systemic lupus erythematosus; if you are 

pregnant, planning to become pregnant.

How will this medicine affect your daily life?

Use of this medicine may impair alertness, and caution should therefore be exercised when driving a car, operating dangerous 

machinery and in any activity which requires alertness.

Do not drink wine or alcoholic beverages while under treatment with this medicine, especially at the start of treatment.

Tritace Comp can interfere with results of parathyroid function or anti-doping tests.

Drug interactions:

If you are taking another drug, including non-prescription medicines and food supplements, 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.

Combination with the following medicines can reduce the effectiveness of Tritace Comp:

Medicines to relieve pain and inflammation (for example, NSAIDs such as ibuprofen or indomethacin and aspirin); medicines to treat 

low blood pressure, shock, heart failure, asthma or allergies, such as ephedrine, noradrenalin or adrenalin.

Combination with the following medicines can increase the risk of side effects:

Medicines to relieve pain and inflammation (for example, NSAIDs such as ibuprofen or indomethacin and aspirin); medicines that 

may lower your blood potassium level such as medicines for constipation, diuretics, amphotericin B (given for fungal infections), and 

ACTH given to test adrenal gland function; medicines to treat cancer (chemotherapy); medicines for heart problems such as medicines 

to treat arrhythmias; medicines to prevent rejection of organ transplants such as cyclosporin; diuretics such as furosemide; medicines 

that can raise the blood potassium level such as spironolactone, triamterene, amiloride, potassium salts and heparin; steroids for 

treatment of inflammation such as prednisone or prednisolone; calcium supplements; allopurinol (given to reduce the level of uric 

acid in the blood); procainamide (given for treatment of heart rhythm problems); cholestyramine (to lower the amount of lipids in 

your blood); carbamazepine (for epilepsy).

Combining Tritace Comp with the following medicines can affect their action:

Medicines for diabetes such as oral medicines and insulin - Tritace Comp may reduce your blood sugar level, monitor your blood 

sugar level strictly when taking Tritace Comp; lithium (given for treatment of mental problems) - Tritace Comp can cause an elevated 

level of lithium in the blood, the doctor must monitor lithium levels carefully while you are taking Tritace Comp; muscle relaxants; 

quinine for malaria; medicines containing iodine can be given if you are undergoing scanning or X-ray in a hospital; penicillin (for 

infections); oral blood thinning medicines such as warfarin.

Side effects:

As with all medicines, Tritace Comp can cause side effects. These effects do not occur in everyone taking the medicine.

Stop treatment with Tritace Comp and refer to the doctor immediately if you experience any of the following serious side effects 

- you may require urgent medical treatment: swelling of the face, lips or throat which make it difficult to swallow or breathe, as well 

as tingling and rash - these could be signs of a severe allergic reaction to Tritace Comp; severe skin reaction including rash, mouth 

ulcers, worsening of a pre-existing skin disease, reddening, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic 

epidermal necrolysis or erythema multiforme).

Tell your doctor immediately if you experience any of the following side effects: increased heart rate, strong and irregular heartbeat 

(palpitations), chest pain, tightness in your chest or a more serious problem such as heart attack or stroke; shortness of breath, coughing 

or fever lasting 2-3 days and reduced appetite - these could be signs of a lung problem; bruising more easily, bleeding for longer than 

normal, any sign of bleeding (e.g., bleeding from the gums), blue marks on the skin or getting infections more easily than usual, sore 

throat and fever, feeling tired, faint, dizzy or having pale skin - these can be signs of blood or bone marrow problems; severe abdominal 

pain which may radiate to the back - this could be a sign of pancreatitis; fever, chills, tiredness, loss of appetite, abdominal pain, nausea, 

yellowing of the skin or eyes (jaundice) - these can be signs of liver problems such as inflammation of the liver or liver damage.

Other side effects include:

Please tell your doctor if any of the following effects becomes serious or lasts longer than a few days.

Common effects (occurring in less than 1 in 10 people): headache or feeling tired or weak; feeling dizzy - this is more likely to happen 

at the beginning of Tritace Comp treatment or when the dosage is raised; dry cough or bronchitis; blood tests showing higher blood 

sugar levels than usual - if you have diabetes this may exacerbate your disease; blood tests showing higher uric acid or lipid levels 

than usual; pain, redness and swelling of the joints.

Uncommon effects (occurring in less than 1 in 100 people): skin rash with or without raised areas; flushing, fainting, low blood pressure, 

particularly when standing up or sitting up quickly; balance problems; itching or unusual skin sensations such as stinging, numbness 

or tingling; loss of or change in the sense of taste; sleep problems; feeling depressed, anxious, more nervous than usual or restless; 

blocked nose, sinusitis, difficulty breathing; inflamed gums, swollen mouth; the eyes - redness, itching, swelling or tearing; ringing in 

the ears; blurred vision; hair loss; chest pain; muscle pain; constipation, abdominal pain; indigestion or feeling sick; urinating more 

than usual; sweating more than usual or feeling thirsty; loss of or reduced appetite; increase or change in the heart rate; swelling of 

the arms and legs - may be a sign of the body retaining more fluids than usual; fever; impotence in men; blood test results showing a 

reduction in the number of red blood cells, white blood cells or platelets or in the amount of hemoglobin; blood test results indicating 

changes in function of the liver, pancreas or kidneys; blood test results showing a lower blood potassium level than usual.

Very rare effects (occurring in less than 1 in 10,000 people): vomiting, diarrhea or heartburn; redness or swelling of the tongue or 

dry mouth; blood test results showing a higher blood potassium level than usual.

Other side effects reported:

Please tell your doctor if any of the following effects becomes serious or lasts longer than a few days.

Difficulty concentrating, feeling restless or confused; change of color in the fingers and toes when you are cold and then stinging 

or pain when you warm up (Raynaud's phenomenon); breast enlargement in men; blood clots; hearing disturbances; conjunctival 

dryness; objects appearing yellow; dehydration; swelling, pain or redness of the cheeks (inflammation of the salivary glands); 

intestinal angioedema manifested by abdominal pain, vomiting or diarrhea; increased sensitivity to sunlight; severe peeling of the 

skin, stinging, lumpy rash or other skin problems such as reddish rash of the face or forehead; skin rash or bruises; blotches on the 

skin and sensation of cold in the extremities; nail problems (for instance loosening or detachment of the nails from their bed); muscle 

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

אפור םשרמב תבייח וז הפורת

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

2010 רבמבונב רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ

פמוק סייטירט  פמוק סייטירט

ג"מ  25/ ג"מ  5  ג"מ  12.5/ ג"מ  2.5

תוילבט  תוילבט

:בכרה

:הליכמ הילבט לכ  :הליכמ הילבט לכ

Ramipril   5 mg   Ramipril  2.5 mg

Hydrochlorothiazide  25 mg   Hydrochlorothiazide  12.5 mg

:םיליעפ יתלב םירמוח

Pregelatinized starch, Microcrystalline cellulose, Hydroxypropylmethylcellulose, Sodium stearyl fumarate.

.ידיזאית ןתשמ +  ACE  בכעמ :תיטיופרת הצובק

.םד ץחל רתיב לופיטל :תיאופר תוליעפ

?רישכתב שמתשהל ןיא יתמ

.הקינימ ךניה םא וא םינורחאה ןוירהה ישדוח תששב רישכתב שמתשהל ןיא

 דיזאיתורולכורדיהל וא םד ץחל תדרוהל םישמשמה  ACE  יבכעמ תצובקמ רחא רישכתל וא לירפימרל תושיגר העודי םא שמתשהל ןיא

.הפורתה יביכרממ דחאל וא םידימאנופלוסל וא םירחא םינתשמ םידיזאיתל וא

.angioedema  - תארקנה הרומח תיגרלא הבוגתמ רבעב תלבס םא שמתשהל ןיא

.renal   artery   stenosis  - הילכל םד תקפסאב היעבמ ת/לבוס ךניה םא שמתשהל ןיא

.םד ןוניס לש רחא גוס וא הזילאיד ת/רבוע ךניה םא שמתשהל ןיא

.הילכה דוקפתב רומח יוקילמ ת/לבוס ךניה םא שמתשהל ןיא

.דבכה דוקפתב רומח יוקילמ ת/לבוס ךניה םא שמתשהל ןיא

 ןדיס לש ףדוע םע םילוח וא םדב תוכומנ ןרתנ וא ןגלשא תומר :ןוגכ םיחלמה תמרב תוערפהמ ת/לבוס ךניה םא שמתשהל ןיא

.םדב

:לופיטה תלחתה ינפל אפורב ץעוויהל ילבמ הפורתב שמתשהל ןיא

 ,םיחלמ תלד הטאיד ,תרבגומ העזה ,לושלש ,האקה תובקעב( םילזונ וא םיחלמ דוביא ;הילכב וא דבכב ,בלב תויעב :מ ת/לבוס ךניה םא

 וא םירובד תוציקעל היגרלאה תתחפהל לופיט רובעל ת/דמוע ךניה םא ;)הזילאיד תרבע םא וא תכשוממ הפוקתל םינתשמ תליטנ

 ךניה םא ;ההובג ךמדב ןגלשאה תמר םא ;םייניש לופיטב וא חותינב המדרה ירמוח לבקל ת/דמוע ךניה םא ;)היצזיטיסנסד( תוערצ

.ןוירה תננכתמ ,ןוירהב ךניה םא ;) systemic   lupus   erythematosus ( תבאז וא המרדורלקס ןוגכ רוביחה תמקר תולחממ ת/לבוס

?ךלש םוי םויה ייח לע הפורתה עיפשת ךיא

 תבייחמה תוליעפ לכבו תונכוסמ תונוכמ תלעפהב ,בכרב הגיהנב תוריהז בייחמ ןכ לעו תונריעב םוגפל לולע וז הפורתב שומישה

.תונריע

.לופיטה תליחתב דחוימבו הפורתה םע לופיטה תפוקתב םיפירח תואקשמ וא תוניי תותשל ןיא

.anti-doping  תקידב לע וא דיאוריתאראפה דוקפת תקידב תואצות לע עיפשהל לוכי פמוק סייטירט

:תויתפורת-ןיב תובוגת

 ,תרחא הפורתב לופיט התע הז תרמג םא וא ,הנוזת יפסותו אפור םשרמ אלל תורכמנה תופורת ללוכ ,תפסונ הפורת ת/לטונ ךניה םא

.תויתפורת-ןיב תובוגתמ םיעבונה תוליעי-יא וא םינוכיס עונמל ידכ לפטמה אפורל חוודל ךילע

:פמוק סייטירטה תוליעי תתחפהל םורגל לוכי תואבה תופורתה םע בוליש

 תקיפס יא ,קוש ,ךומנ םד ץחלב לופיטל תופורת ;)ןיריפסאו ןיצאתמודניא וא ןפורפוביא ומכ  NSAID  אמגודל( תקלדו באכב הלקהל תופורת

.ןילנרדא וא ןילנרדארונ ,ןירדפא ומכ תויגרלא וא המתסא ,בל

:יאוול תועפותל יוכיסה תרבגהל םורגל לוכי תואבה תופורתה םע בוליש

 ןגלשאה תמר תא תיחפהל תולולעה תופורת ;)ןיריפסאו ןיצאתמודניא וא ןפורפוביא ומכ  NSAID  אמגודל( תקלדו באכב הלקהל תופורת

 תופורת ;לנרדאה תטולב דוקפת תקידבל ןתינה  ACTH  -ו )תויתיירטפ תוקלדל ןתינ(  B  ןיצירתופמא ,םינתשמ ,תוריצעל תופורת ומכ ךמדב

 ;ןירופסולקיצ ןוגכ לתש תייחד תעינמל תופורת ;בצק תויעבב לופיטל תופורת ומכ בלב תויעבל תופורת ;)היפרתומיכ( ןטרסב לופיטל

 ןגלשא יחלמ ,דירולימא ,ןרטמאירט ,ןוטקלונוריפס ןוגכ םדב ןגלשאה תמר תא תולעהל תולוכיה תופורת ;דימסורופ ןוגכ תונתשמ תופורת

 ;)םדב תירואה הצמוחה תמר תתחפהל ןתינ( לונירופולא ;ןדיס יפסות ;ןולוזינדרפ וא ןוזינדרפ ןוגכ תקלדב לופיטל םידיאורטס ;ןירפהו

.)היספליפאל( ןיפזאמאבראק ;)םדב ןמושה תומכ תדרוהל( ןימאריטסלוכ ;)בלה בצקב תויעבב לופיטל ןתינ( דימאניאקורפ

:ןתוליעפ לע עיפשהל לוכי תואבה תופורתה םע פמוק סייטירט בוליש

 תמר רחא תונדפקב בוקעל שי ,ךמדב רכוסה תמר תא תיחפי פמוק סייטירטו ןכתיי - ןילוסניאו תוימופ תופורת ןוגכ תרכוסל תופורת

 םויתילה תמר תאלעהל םורגל לוכי פמוק סייטירט - )תוישפנ תויעבב לופיטל ןתינה( םויתיל ;פמוק סייטירט תליטנ ןמזב םדב רכוסה

 תופורת ;הירלמל ןיניק ;םירירשה תייפרהל תופורת ;פמוק סייטירט תליטנ ןמזב םויתילה תמר רחא תונדפקב בוקעל אפורה לע ,םדב

 םדה לולידל תופורת ;)םימוהיזל( ןיליצינפ ;םילוח-תיבב ןגטנר םוליצ וא הקירס ת/רבוע ךניה םא ןתניהל תולוכי ,) iodine ( ןידוי תוליכמה

.ןיראפראוו ןוגכ הפה ךרד תונתינה

:יאוול תועפות

.הפורתה תא ת/לטונש ימ לכ לצא תועיפומ אל ולא תועפות ,יאוול תועפותל םורגל לוכי פמוק סייטירט ,תופורתה לכב ומכ

 י/קקדזתו ןכתיי - תואבה תורומחה יאוולה תועפותמ תחאב ה/שח ךניה םא דימ אפורל י/הנפו פמוק סייטירטב לופיטה י/קספה

 תויהל םילוכי ולא - החירפו ץוצקעל םגו המישנ וא העילב יישקל תמרוגה עולה וא םייתפשה ,םינפה תוחיפנ :ףוחד יאופר לופיטל

 ,תמייק תירוע הלחמ לש הרמחה ,הפב םיביכ ,החירפ תללוכה הפירח תירוע הבוגת ;פמוק סייטירטל הפירח תיגרלא הבוגתל םינמיס

Erythema   multiforme  וא  Toxic   epidermal   necrolysis  , Stevens-Johnson  םורדניס ןוגכ( רועה לש תוקתנתה וא תויחופלש ,תוימומדא

 ,) palpitations ( תורידס אלו תוקזח בל תומיעפ ,בלה בצק תרבגה :תואבה יאוולה תועפותמ תחאב ה/שח ךניה םא דימ אפורל י/חווד

 ןובאיתב התחפהו םימי 2-3 םיכשמנה םוח וא לועיש ,המישנ רצוק ;ץבש וא בל ףקתה ומכ רתוי הרומח היעב וא הזחב ץחל ,הזחב באכ

 םומידל והשלכ ןמיס ,ליגרהמ ךורא ןמז ךשמל םומיד ,תולק רתיב הלבח ינמיס תעפוה ;תואירב היעבל םינמיס תויהל םילוכי ולא -

 ,תופייע תשגרה ,םוחו ןורגב באכ ,ליגרה בצמה תמועל תולקב םימוהיז תעפוה וא רועה לע םילוחכ םינמיס ,)םייכינחהמ םומיד אמגודל(

 - בגל ןירקהל לוכיש רומח ןטב באכ ;םצעה חמב וא םדב תויעבל םינמיס תויהל םילוכי ולא - רוויח רוע עבצ וא תרוחרחס ,תופלעתה

 םילוכי - )תבהצ( םייניעה וא רועה תבהצה ,הליחב ,ןטב באכ ,ןובאית דוביא ,תופייע ,תורומרמצ ,םוח ;בלבלב תקלדל ןמיס תויהל לוכי

.דבכב העיגפ וא דבכב תקלד ןוגכ דבכב תויעבל םינמיס תויהל

:תוללוכ תופסונ יאוול תועפות

.םימי רפסממ רתוי תכשמנ וא הרימחמ הטמ תוטרופמה תועפותהמ תחא םא ךלש אפורל י/עדוה אנא

 ריבס - תרוחרחס תשוחת ;השלוח וא תופייע תשגרה וא שאר באכ :)םישנא 10 ךותמ 1 -מ תוחפב תועיפומ( תוחיכש תועפות

 תוארמה םד תוקידב ;סיטיכנורב וא שבי לועיש ;פמוק סייטירטה לש ןונימה תאלעהב וא פמוק סייטירטב לופיטה תליחת םע עיפותש

 ההובג המר תוארמה םד תוקידב ;ךתלחמ תא רימחהל לוכי הז בצמ תרכוסמ ת/לבוס ךניה םא - םדב רכוס לש ליגרהמ ההובג המר

.םיקרפמה לש תוחיפנו תוימומדא ,באכ ;םינמוש וא תירוא הצמוח לש ליגרהמ

 ץחל ,תופלעתה ,המדאה ;םיהבגומ םירוזא ילב וא םע רועב החירפ :)םישנא 100 ךותמ 1 -מ תוחפב תועיפומ( תוחיכש אל תועפות

 וא תומדריה ,ץוצקע ןוגכ הליגר אל תירוע תושיגר וא דוריג ;לקשמ יווישב תויעב ;תוריהמב םיבשייתמ וא םידמענשכ דוחייב ךומנ םד

 ,םותס ףא ;החונמ רסוח וא ליגרהמ ההובג תונבצע ,הדרח ,ןואכיד תשגרה ;הניש תויעב ;םעטה שוחב יוניש וא דוביא ;לומינ תשוחת

 ;םיינזואב םילוצלצ ;תעמד וא תוחיפנ ,ץוצקע ,תוימומדא - םייניעב ;הפב תוחיפנ ,םייכינחב תקלד ;המישנ יישק ,םיסוניסה לש תקלד

 ;ליגרהמ תרבגומ הנתשה ;ילוח תשגרה וא לוכיע יישק ;ןטב יבאכ ,תוריצע ;םירירש יבאכ ;הזחב םיבאכ ;רעיש דוביא ;הייאר שוטשט

 תויהל הלוכי - םיילגרו תועורז תוחיפנ ;בלה בצקב יוניש וא היילע ;ןובאית דוביא וא הדירי ;אמצ תשגרה וא ליגרהמ תרבגומ העזה

 יאת ,םימודאה םדה יאת רפסמב הדירי תוארמה םד תקידב תואצות ;םירבגב תונוא ןיא ;םוח ;ליגרהמ רתוי ףוגב םילזונ תריצאל ןמיס

 תואצות ;תוילכה וא בלבלה ,דבכה דוקפתב יוניש לע תודיעמה םד תוקידב תואצות ;ןיבולגומהה תומכב וא םדה תויסט וא םינבלה םדה

.ליגרהמ הכומנה ךמדב ןגלשא תמר לע תוארמה םד תקידב

 וא ןושלה תוחיפנ וא תוימומדא ;תברצ וא לושלש ,תואקה :)םישנא 10,000 ךותמ 1 -מ תוחפב תועיפומ( רתויב תורידנ תועפות

.ליגרהמ ההובגה ךמדב ןגלשא תמר לע תוארמה םד תקידב תואצות ;הפב שבוי

:וחוודש תופסונ יאוול תועפות

.םימי רפסממ רתוי תכשמנ וא הרומח תישענ הטמ תוטרופמה תועפותהמ תחא םא ךלש אפורל י/עדוה אנא

 באכ וא ץוצקע תשגרה ןכמ רחאלו ךל רק רשאכ םיילגרהו םיידיה תועבצא לש עבצב יוניש ;לובלב וא החונמ רסוח תשגרה ,זוכיר יישק

 ;םיבוהצ םיארנה םימצע ;תימחלב שבוי ;העימשב תוערפה ;םד ישירק ;םירבגב הזחה תלדגה ;) Raynaud ’ s   phenomenon ( םמחתמשכל

 באכב תאטבתמה ) intestinal   angioedema ( םייעמב תוחיפנ ;)קורה תטולב לש תקלד( םייחלב תוימומדא וא באכ ,תוחיפנ ;תושבייתה

 תורחא תוירוע תויעב וא םישוג תרוצב החירפ ,ץוצקע ,רועה לש רומח ףוליק ;שמשה רואל תרבגומ תושיגר ;לושלש וא האקה ,ןטב

 רורחש אמגודל( םיינרופיצב תויעב ;םייפגב רוק תשגרהו רועב םימתכ ;רועב תולבח וא תחרפת ;חצמב וא םינפב תימומדא החירפ ומכ

 הקושתב הדירי ;םירירשה תוצווכתה וא השלוח ;םיקרפמה תא זיזהל תלוכי יא וא םירירש ןוישיק ;)הסיסבמ ןרופיצה לש הדרפה וא

 םד יאתב היילע ;ליגרהמ ההובג ןתשב רכוס תמר ;תוילכב היעבל ןמיס תויהל הלוכי - ןתשב םד תעפוה ;םישנב וא םירבגב תינימה

 םד תקידב תואצות ;ךמדב םדה יאת טועימ לע תוארמה םד תוקידב תואצות ;םד תוקידבב התפצנש - ) eosinophilia ( םימיוסמ םינבל

 יישק ;םירבד לש תוחירב יוניש ;תובוגתב יוניש וא הטאה ;ךמדב דירולכו םויזנגמ ,ןדיס ,ןרתנ :ןוגכ םיחלמה תומרב יוניש לע תוארמה

.המתסא לש הרמחה וא המישנ

:ןונימ

.תצלמומה הנמה לע רובעל ןיא .דבלב אפורה תוארוה יפל ןונימ

.18 ליגל תחתמ םירגבתמו םידליל תדעוימ הניא וז הפורת

.לפטמה אפורה ידי-לע עבקנש יפכ םיעובק םינמזב וז הפורתב שמתשהל שי

!דחיב תונמ יתש לוטיל ןיא ןפוא םושב .אבה עובקה הליטנה ןמזב הנמ לוטיל שי ,עובקה ןמזב וז הפורת לוטיל תחכש םא

:שומישה ןפוא

.החורא ירחא וא ןמזב ,ינפל הפורתה תא תחקל ןתינ .םימ םע הפורתה תא עולבל .קסרל ןיא !סועלל ןיא

.רקובב תחא הנמב הפורתה תא לוטיל ץלמומ

?לופיטה תחלצהל עייסל י/לכות דציכ

.אפורה ידי-לע ץלמוהש לופיטה תא םילשהל ךילע

.אפור םע תוצעייתה אלל הפורתב לופיטה קיספהל ןיא ךתואירב בצמב רופיש לח םא םג

 י/ענמת ךכ ידי-לעו תוקונית וא/ו םידלי לש םדי גשיהל ץוחמ רוגס םוקמב רומשל שי תרחא הפורת לכו וז הפורת !הלערה י/ענמ

 רתיה תנמ תא תלטנ ה/תא םא( םילוח-תיב לש ןוימ רדחל דימ י/הנפ ,הפורתה ןמ דלי עלב תועטב םא וא רתי תנמ תלטנ םא .הלערה

 תשרופמ הארוה אלל האקהל םורגל ןיא .ךתיא הפורתה תזירא י/אבהו ,)ךתוא חקיי והשימש י/גאד אלא םילוחה תיבל ךמצעב י/גהנת לא

.ךירכמ וא ךינכש ,ךיבורקל וז הפורת י/ןתית לא .קיזהל הלולע איה ת/רחא הלוחב ,ךתלחמב לופיטל המשרנ וז הפורת !אפורמ

.םהל ה/קוקז ךניה םא םייפקשמ ביכרהל שי .הפורת ת/לטונ ךניהש םעפ לכב הנמהו תיוותה קודבל שי !ךשוחב תופורת לוטיל ןיא

 ךיראתל בל םישל אנ .דבלב תלבגומ הפוקתל תורמשנ תופורת ,םיצלמומה הנסחאה/הזיראה יאנת יפל םג .25 0 C  -ל תחתמ :הנסחא

.הזירא התואב תונוש תופורת ןסחאל ןיא .הפורתה תא ךל קפיסש חקורב ץעוויהל ךילע ,קפס לש הרקמ לכב !רישכתה לש הגופתה

.אפורל י/הנפ אנא ,המ רבדב ה/חוטב ךניא וא יהשלכ הלאש ךל שי םא .רישכתה לע עדימה לכ תא ללוכ אל הז ןולע

122 28 30188 :ג"מ 25/ג"מ 5 פמוק סייטירט  122 27 30187 :ג"מ 12.5/ג"מ 2.5 פמוק סייטירט  :הפורתה םושיר 'סמ

.הילטיא ,סיטנווא-יפונאס :ןרצי

be a sign of kidney problems; higher level of sugar in the urine than usual; increase in certain white blood cells (eosinophilia) - that 

was observed in blood tests; blood test results showing too few blood cells In your blood; blood test results showing a change in the 

level of salts, e.g.: sodium, calcium, magnesium and chloride in your blood; slowed or changed reactions; change in the way things 

smell; difficulty breathing or worsening of asthma.

Dosage:

Dosage is according to doctor's instructions only. Do not exceed the recommended dosage.

This medicine is not intended for administration to children and adolescents under the age of 18.

This medicine is to be taken at specific time intervals as determined by the attending doctor. If you forget to take this medicine at the 

specified time, take a dose at the next scheduled dosing time. Never take two doses together!

Directions for use:

Do not chew! Do not crush. Swallow the medicine with water. The medicine can be taken before, during or after a meal.

It is recommended that you take the medicine in one dose in the morning.

How can you contribute to the success of the treatment?

Complete the full course of treatment as instructed by the doctor.

Even if there is an improvement in your health, do not discontinue use of this medicine without consulting your doctor.

Avoid poisoning! This medicine, and all other medicines, must be stored in a safe place out of the reach of children and/or infants, 

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

hospital emergency room (if you have taken overdose, do not drive to the hospital yourself, but have someone take you) 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, neighbors 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: Store below 25°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.

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, 

ask your doctor.

License number:  Tritace Comp 2.5 mg/12.5 mg: 122 27 30187  Tritace Comp 5 mg/25 mg: 122 28 30188

Manufacturer: sanofi-aventis, Italy.

License holder: sanofi-aventis Israel Ltd., P.O. Box 8090, Netanya 42504.

TRIT COMP TAB PL SH 020910

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Enforcement Report for the Week of September 12, 2018

Enforcement Report for the Week of September 12, 2018

Recently Updated Records for the Week of September 12, 2018 Last Modified Date: Friday, September 07, 2018

FDA - U.S. Food and Drug Administration

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

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

8-8-2018

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

19-7-2018

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

FDA - U.S. Food and Drug Administration

17-7-2018

The PictSweet Company Recalls 12 Ounce Steam’ables Baby Brussel Sprouts for Undeclared Milk and Soy Allergens

The PictSweet Company Recalls 12 Ounce Steam’ables Baby Brussel Sprouts for Undeclared Milk and Soy Allergens

Bells, TN – The Pictsweet Company has recalled 960 cases of Pictsweet Farms 12-ounce Steam’ables Baby Brussels Sprouts because they may contain undeclared milk and soy allergens. People who have an allergy or severe sensitivity to milk or soy may run the risk of serious allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

30-5-2018

12 applications for allocation of special funds related to medicinal cannabis

12 applications for allocation of special funds related to medicinal cannabis

The application deadline for the second allocation of special funds for accumulation of scientific knowledge in regard to the medicinal cannabis pilot programme has now expired. The Danish Medicines Agency received 12 applications.

Danish Medicines Agency

19-4-2018

April 12, 2018: Chinese Citizen Pleads Guilty to Mail Fraud Related to Dietary Supplement Scheme

April 12, 2018: Chinese Citizen Pleads Guilty to Mail Fraud Related to Dietary Supplement Scheme

April 12, 2018: Chinese Citizen Pleads Guilty to Mail Fraud Related to Dietary Supplement Scheme

FDA - U.S. Food and Drug Administration

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

5-9-2018

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application:  https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.usa.gov/xPcpn  #MedicalDevice

FDA - U.S. Food and Drug Administration

27-7-2018

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Celgene Europe B.V.)

EU/3/12/1097 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5043 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/158/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2018)5032 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/146/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/998 (Orchard Therapeutics Ltd)

EU/3/12/998 (Orchard Therapeutics Ltd)

EU/3/12/998 (Active substance: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene) - Transfer of orphan designation - Commission Decision (2018)5062 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/014/12/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Pfizer Europe MA EEIG)

EU/3/12/1066 (Active substance: tafamidis) - Transfer of orphan designation - Commission Decision (2018)5066 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/115/12/T/01

Europe -DG Health and Food Safety

22-7-2018

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device and earlier agency actions

FDA - U.S. Food and Drug Administration

19-7-2018

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Active substance: Humanised single chain monoclonal antibody against CD37) - Transfer of orphan designation - Commission Decision (2018)4839 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/128/12/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/12/999 (Merck Sharp and Dohme B.V.)

EU/3/12/999 (Merck Sharp and Dohme B.V.)

EU/3/12/999 (Active substance: Letermovir) - Transfer of orphan designation - Commission Decision (2018)4104 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/008/12/T/02

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

2-6-2018

EU/3/12/1046 (Novartis Europharm Limited)

EU/3/12/1046 (Novartis Europharm Limited)

EU/3/12/1046 (Active substance: Mavoglurant) - Transfer of orphan designation - Commission Decision (2018)3631 of Sat, 02 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/059/12/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/12/1063 (Novartis Europharm Limited)

EU/3/12/1063 (Novartis Europharm Limited)

EU/3/12/1063 (Active substance: Panobinostat) - Transfer of orphan designation - Commission Decision (2018)3041 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/12/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Active substance: Humanised monoclonal antibody against P-selectin) - Transfer of orphan designation - Commission Decision (2018)3040 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/026/12/T/02

Europe -DG Health and Food Safety

6-4-2018

EU/3/12/1072 (Le4D Limited)

EU/3/12/1072 (Le4D Limited)

EU/3/12/1072 (Active substance: Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotrophic factor) - Transfer of orphan designation - Commission Decision (2018)2008 of Fri, 06 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/11/T/01

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety

28-3-2018

EU/3/12/1092 (Astellas Pharma Europe B.V.)

EU/3/12/1092 (Astellas Pharma Europe B.V.)

EU/3/12/1092 (Active substance: Chimeric monoclonal antibody against claudin 6) - Transfer of orphan designation - Commission Decision (2018)2009 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/147/12/T/01

Europe -DG Health and Food Safety

5-3-2018

EU/3/12/975 (Voisin Consulting S.A.R.L.)

EU/3/12/975 (Voisin Consulting S.A.R.L.)

EU/3/12/975 (Active substance: Carbetocin) - Transfer of orphan designation - Commission Decision (2018)1425 of Mon, 05 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/11/T/01

Europe -DG Health and Food Safety