اتروڤنت

المعلومات الرئيسية

  • اسم تجاري:
  • اتروڤنت
  • الشكل الصيدلاني:
  • INHALER
  • طريقة التعاطي:
  • INHALATION
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • BOEHRINGER INGELHEIM PHARMA GmbH & CO.KG

المستندات

الأقلمة

  • متاح في:
  • اتروڤنت
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • IPRATROPIUM BROMIDE
  • الخصائص العلاجية:
  • For the relief of symptoms of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema.

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 130013093400
  • تاريخ الترخيص:
  • 01-01-2009
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة: نشرة المعلومات, خصائص المنتج

רשואוקדבנונכותותואירבהדרשמי"עעבקנהזןולעטמרופ

1986-ו"משתה(םירישכת)םיחקורהתונקתיפלןכרצלןולע

אפורםשרמבתבייחוזהפורת

הפורתבי/שמתשתםרטבופוסדעןולעהתאןויעבי/ארק

טנבורטא

CFC -מישפוח

ףאשמ

בכרה

:תררחשמהפיאשלכ

Ipratropium Bromide 20 mcg

םיליעפיתלבםיביכרמ

1,1,1,2-tetrafluoroethane (propellant HFA134a), ethanol absolute (99%),

purified water, citric acid anhydrous.

תיטיופרתהצובק

.יגרנילוכיטנא

תיאופרתוליעפ

.המישנהיכרדבתונופמיסביחרמ

.המישנרצוקלתמרוגהתונופמיסהתיוועמםילבוסהםילוחבהלקהלתדעוימהפורתה

?רישכתבשמתשהלןיאיתמ

םימודםירישכתלואהזרישכתלתושיגרהעודיםאוזהפורתבשמתשהלןיא

.ןיפורטאםיליכמה

ןוירהבךניהםאלופיטהתלחתהינפלאפורבץעוויהלילבמהפורתבשמתשהלןיא

לופיטהתלחתהינפלאפורבץעוויהלילבמהפורתבשמתשהלןיא,ןכומכ.הקינמוא

תוימומדא,תוחוניאןוגכ)םייניעהדוקפיתביוקילמרבעבתלבסואת/לבוסךניהםא

,(המוקואלג,תוינועבצתויומדואתוליהתייאר,הייארשוטשט,םייניעבבאכוא

הלחמהמלבוסךניהםאוא,ןתשהיכרדבהמיסח/תינומרעהתטולבתלדגהמ

תעבהלוחהתבוגתירחאבקעמםייקליוצר.(CF)סיזורביפקיטסיסתיתשרותה

.לופיטהתליחת

?ךלשםויםויהייחלעהפורתהעיפשתךיא

תלוכי)היצדומוקאבישוק,תורוחרחסןוגכיאוולתועפותשוחלה/לולעךניה

.וזהפורתבלופיטהתפוקתךשמבהייארשוטשטוןושיאהתובחרתה,(דקמתהל

תנכוסמתוליעפמענמיהלךילעל"נהיאוולתועפותבה/שיגרמךניהוהדימבןכלע

.תונוכמתלעפהובכרבהגיהנןוגכ

שיבכהתברקבםיקחשממואםיינפואלעהביכרמםריהזהלשי,םידלילרשאב

.המודכו

תורהזא

אפורבץעוויהלשי)תונופמיסהתיוועלשדחףקתהבלופיטלדעוימאלרישכתה

.(הלאםירקמלםיאתמרישכתיבגל

החירפןוגכ,וזהפורתבשומישהרחאלשחרתהלתולולעתוידיימתויגרלאתובוגת

המישניישקלםורגללולעה,תירירהוארועהלשהריהמתוחפנתה,תלרח,רועב

הריהמתוחתפתהואןורגבוהפבתוחיפנ,המישנהיכרדלשתורציה,(angioedema)

.(anaphylaxis)םייחתונכסמהתויגרלאתובוגתלש

לעךלשאפורבץעוויהלךילע,תורימחמואתוכשמתמךלשהמישנהתויעבוהדימב

.לופיטהתטישתאןוחבלתנמ

בטיהףוטשלשיםייניעהםעעגמלשהרקמב.םייניעהםערישכתהעגמעונמלשי

.םימב

תויתפורת-ןיבתובוגת

ללוכ,תרחאהפורתבלופיטההתעהזתרמגםאוא,תפסונהפורתת/לטונךניהםא

ידכלפטמהאפורלחוודלךילע,הנוזתיפסותואאפורםשרמאללתשכרשתופורת

תופורתיבגלדחוימב,תויתפורת-ןיבתובוגתמםיעבונהתוליעי-יאואםינוכיסעונמל

ןיליפואתןוגכ)םיניטנסקםיליכמהםירישכתוהמטסאדגנתופורת:תואבהתוצובקהמ

.(ויתורזגנו

יאוולתועפות

תועפשהעיפוהלתולולעהבשומישהןמזב,הפורתהלשהיוצרהתוליעפלףסונב

ללוכ)לוכיעהתכרעמבתויעב,שארבאכ,הליחב,לועישואןורגביוריג:ןוגכיאוול

ידכ.הפבשבויואתונבצע,תרוחרחס,הליחב,רועביוריג,(האקהו,לושלש,תוריצע

תסיעלואםינטקחרקישוג,הירכוסתציצמברזעהלןתינהפבשבויהלעלקהל

.אפורלי/הנפםייעובשירחאתפלוחהניאהעפותהםא.קיטסמ

:תורחאיאוולתועפות

,(תשקהיעבצ)תינועבצהייאר,םיבחרומםינושיא,רידסאלוא/וריהמבלקפוד

,(היצלהניאבשומישמהאצותכםג)המישנהיכרדבתורציה,םייניעבתוימומדא

תוחיפנ,רובידהוהמישנהלעעיפשהלתולולעהלוקהירתימבתוימואתפתויוצווכתה

לשהריהמתוחפנתה,יוריג,החירפ,הפהללחבתוחיפנותקלד,ןורגבשבוי,עולב

,המישניישקלםורגללולעה(angioedema)ןושלהוא/וםייתפשה,םינפה,רועה

םייחתונכסמהתויגרלאתובוגתלשהריהמתוחתפתהוא,רתיתושיגר,תלרח

.(anaphylaxis)

תדחוימתוסחייתהתובייחמהתועפות

יבאכוא,(דקמתהלתלוכי)היצדומוקאבישוק,הייארשוטשטןוגכהמוקואלגינמיס

.אפורלי/הנפ:םייניע

ריהמקפודוא(תוקזחבלתוקיפד)תויצטיפלפ,םייתפשבוהפבםיביכ,רועבהחירפ

(המישניישק,הזחבץחלתלדגה)תונופמיסתיוועתרמחה,ןתשתריצע,(רידנ)

!דימאפורלי/הנפולופיטהי/קספה:(רידנ)

לחםאוא,הזןולעבונייוצאלשיאוולתועפותה/שיגרמךניהובשהרקמלכב

.דימאפורהםעץעייתהלךילע,תיללכהךתשגרהביוניש

םידליבתויתפורתןיבתובוגתויאוולתועפות

תפסונהפורתלכלעןכויאוולתועפותלכלעלפטמהאפורלחוודלםירוההלע

.ה/דלילתנתינה

.וטרופשתודחוימתויתפורת-ןיבתובוגתויאוולתועפותליעלהאר

ןונימ

.דבלבאפורהתוארוהיפל

.תצלמומההנמהלערובעלןיא

.דבלבאפורהתוארוהיפל:םידלילןונימ

.םינש6ליגלתחתמםידלילתדעוימהניאוזהפורת

!בלי/םיש

.םימהברהבבטיהףוטשלשיןיעבהעיגפלשהרקמב.םייניעםעעגממענמיהלשי

שומישהןפוא

"ףאשמטנבורטאבשמתשהלדציכ"י/האר

.תוליעיהתרבגהל-הפיאשלהפיאשןיבהקדי/ןתמה-תפסונהפיאשבךרוצשיםא

!הלערהי/ענמ

וא/וםידלילשםדיגשיהלץוחמרוגסםוקמברומשלשיתרחאהפורתלכווזהפורת

.הלערהענמתךכידילעותוקונית

לשןוימרדחלדימי/הנפ,הפורתהןמדליףאשתועטבםאוארתיתנמתלטנםא

.ךתיאהפורתהתזיראי/אבהו,םילוחתיב

!אפורהמתשרופמהארוהאללהאקהלי/םורגתלא

.קיזהלהלולעאיה,(ת)רחאהלוחב;ךתלחמבלופיטלהמשרנוזהפורת

.ךירכמואךינכש,ךיבורקלוזהפורתי/ןתיתלא

.הפורתת/לטונךניהשםעפלכבהנמהותיוותהי/קודב!ךשוחבתופורתלוטילןיא

.םהלה/קוקזךניהםאםייפקשמי/בכרה

הנסחה

-לתחתמןסחאלשי

!רואינפמי/נגהוםוחושאמי/קחרה:קילדרמוח!תוריהז

.קירלכימהרשאכםגףורשלוארובשל,בקנלןיא:ץחללכימ!תוריהז

.דבלבתלבגומהפוקתלתורמשנתופורת,םיצלמומההנסחה/הזיראהיאנתיפלםג

ץעוויהלךילע,קפסלשהרקמלכב!רישכתהלשהגופתהךיראתלבלםישלאנ

.הפורתהתאךלקפיסשחקורב

.הזיראהתואבתונושתופורתןסחאלןיא

130013093400:הפורתהםושיר.סמ

ןרצי

ינפמוק & מ"עבהמרפםייהלגניארגנירב

הינמרג,ןייר/םייהלגניא

םושירהלעב

,מ"עבןייטשלאוןיול,ןומולס

.49131הוקת-חתפ,3696ד"ת

.ריואלתוציחל2רורחישי"עי/לחתה,רישכמבןושארהשומישהינפל:בלי/םיש

.ריואלתחאהציחלרורחשי"עי/לחתה,םימי3ךשמבףאשמבשומישהשענאלםא

This leaflet format has been determined by the Ministry of Health and the content

thereof has been checked and approved

PATIENTPACKAGEINSERTINACCORDANCEWITHTHEPHARMACISTS'

REGULATIONS(PREPARATIONS)-1986

This medicine should be dispensed on a doctor's prescription.

Carefully read the package insert in its entirety before using the medicine.

ATROVENT

CFC- Free

Metered aerosol

COMPOSITION

Each metered dose delivers:

Ipratropium Bromide 20mcg

Inactive Ingredients

1,1,1,2-tetrafluoroethane (propellant HFA134a), ethanol absolute (99%),

purified water, citric acid anhydrous.

THERAPEUTIC GROUP

Anticholinergic.

THERAPEUTIC ACTIVITY

Bronchodilator of the airways.

This product is intended for relief in patients who suffer from bronchospasm

which causes difficulty breathing.

WHEN SHOULD THE PREPARATION NOT BE USED?

Do not use this medicine if you have a sensitivity to this preparation or

to similar preparations containing atropine.

Do not take this medicine without consulting a doctor before starting

treatmentif you are pregnant or breastfeeding.The same applies for

patients who are suffering, or have suffered in the past, from impaired

function of the eyes (e.g., eye pain, redness or discomfort, blurred vision,

visual halos or colored images, glaucoma), from enlarged prostatic

gland/urinary tract obstruction, or if you are suffering from hereditary

disease cystic fibrosis (CF).

It is advisable that patient's response be kept under medical supervision

at the start of treatment.

HOW WILLTHIS MEDICINEAFFECTYOUR DAILYLIFE?

You may experience side effects such as dizziness, accommodation

disorder (difficulty to focus), mydriasis and blurred vision during treatment

with this medicine.Therefore, if you experience the above mentioned

side effects you should avoid potentially hazardous tasks such as driving

or operating machinery.

Children should be cautioned against engaging in activities such as

bicycle riding or playing near roads and the like.

WARNINGS

The preparation is not indicated for acute bronchospasm attacks (in these

cases, you must consult a doctor for suitable treatment).

Immediate hypersensitivity reactions may occur after administration of the

product such as rash, nettle rash, angio-oedema (a rapid swelling of the

skin or mucous membranes which may cause difficulty breathing), narrowing

of the airways, swelling of mouth and throat or rapidly progressing, life

threatening allergic reactions (anaphylaxis).

If your breathing problems persist or even worsen: you should consult

your doctor, as your treatment has to be checked.

Avoid contact with the eyes. In case of contact with the eyes, wash them

thoroughly with water.

DRUG INTERACTIONS

If you are taking another drug concomitantly or if you have just finished

treatment with another medicine, including medicines you have bought

without prescription or food supplements, inform the attending doctor, in

order to prevent hazards or lack of efficacy arising from drug interactions.

This is especially important for medicines belonging to the following

groups:antiasthmatics and xanthine-containing preparations (such as

theophylline and its derivatives).

SIDE EFFECTS

In addition to the desired effect of the medicine, adverse reactions may

occur during the course of taking this medicine such ascough or throat

irritation, nausea, headache, gastrointestinal motility disorders (including

consitipation, diarrhea and vomiting), skin irritation, nausea, dizziness or

nervousness, dry mouth.

Note:Before the apparatus is used for the first time, prime it by activating twice into the atmosphere.

For the relief of dry mouth, you may suck candy or small bits of ice in your

mouth or chew gum. However, if dry mouth continues for more than 2

weeks, refer to your doctor.

Other side effects include: fast and/or abnormal heart rate, widened pupils,

halo-vision (rainbow colors), redness of the eye, narrowing of the airways

(including inhalation induced narrowing), laryngospasm (sudden contractions

of the vocal cords -may impact breathing and speech) , pharyngeal edema

(swelling of the upper throat), dry throat, inflammation of the lining of the

mouth, swelling in the mouth, rash, itching,

angioedema - a rapid swelling of the skin or mucous membranes, the

tongue, lips and face which may cause difficulty breathing, nettle rash,

hypersensitivity or rapidly progressing, life threatening allergic reactions

(anaphylaxis).

Side effects that require special attention:

Signs of glaucoma such as blurred vision, accommodation disorder

(difficulty to focus) or eye pain: refer to your doctor.

Skin rash, ulcers in mouth and on lips, palpitations (strong heart beat) or

increased heart rate (rare), urinary retention, worsening of bronchospasm

(increase in chest pressure, breathing difficulties) (rare):stop treatment

and refer to your doctor immediately!

In the event that you experience side-effects not mentioned in this

insert, or if there is a change in your general feeling, you must consult

your doctor immediately.

Adverse Reactions and Drug Interactions in Children

Parents must inform their doctor on any side-effects, as well as any

additional medicine given to the child.

See above for details of specific side-effects and drug interactions.

DOSAGE

According to doctor’sinstructions only.

Do not exceed the recommended dosage.

Dosage for children:according to doctor’sinstructions only.This medicine

is not recommended for use in children under 6years of age.

Attention!

Avoid contact with the eyes. In case of contact with the eyes, wash with

a large amount of water.

DIRECTIONS FOR USE

Refer to "How to useAtrovent MeteredAerosol".

If more than oneinhalation is required, wait one minute between inhalations

for maximum benefit.

AVOIDPOISONING!

This medicine, and all other medicines, must be stored in a safe place out

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

If you have taken an overdose, or if a child has accidentally inhaled the

medicine, proceed immediately to a hospital emergency room and bring

the package of the medicine with you.

Donotinducevomiting 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.

Donottakemedicinesinthedark! Check the label and the doseeach

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

STORAGE

This medicine should be stored below 30 °C.

Caution! Inflammable, keep away from fire and heat and protect from light.

Warning! Pressure container: Do not puncture, break or burn even when

empty.

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.: 130 01 30934 00

Manufacturer

Boehringer Ingelheim

Pharma GmbH & Co. KG

Ingelheim/Rhein, Germany

Licence Holder

Salomon, Levin & Elstein Ltd.,

:ןמקלדכעובשבםעפףאשמהתאתוקנלשי

םתומלעיהחיטבהלידכהייקנףאשמתייפלערומשלבושח

.סיסרתהתאםוסחלםילולעההפורתהלשםיעקשמלש

הסכמתאריסהלךילעתישאר,ףאשמהתאתוקנלתנמלע

.היפהמלכימהתאדירפהלןכמרחאלוקבאהדגנןגמה

ךולכלתוארלהיהיןתינאלשדעםימחםימבהיפהתאי/ץחר

.והשלכ

.ףסונםוחבשומישאללריוואבי/שביויוקינרחאלהיפהתארענ

ינפמןגמההסכמתאולכימהתאי/רזחה,היפהשוביירחאל

.קבא

הפישנמתוענמיהי"עתולקרתיבהיפהןויקינלערומשלןתינ

.היפהךותלא

ותואףושחלוא,חוכבותואחותפל,לכימהתאבקנלןיא

.50°Cלעמתורוטרפמטל

:בושח

הזףאשמםעשומישלדחוימןפואבהמאתוהוהחתופהיפה

ןיאןכל.עובקןפואבןוכנהןונימהלשרורחשחיטבהלתנמלע

שמתשהלןיאןכומכ.םירחאםיפאשמםעדחיהבשמתשהל

.רצומהםעהקפוסרשאוזדבלמהזףאשמםעתורחאתויפב

The metered dose inhaler should be cleaned once a week as follows:

It is important that you keep the mouthpiece of the metered dose inhaler

clean in order to ensure that no deposits of the medicine block the spray.

Toclean the inhaler, please first remove the protective dust cap then

remove the container from the mouthpiece.

Rinse the mouthpiece under warm water until no more dirt is visible.

Shake the mouthpiece after cleaning and allow to air dry without using

additional heat. Once the mouthpiece is dry, replace the container and

the protective dust cap.

It is easier to keep the mouthpiece clean by avoiding breathing into the

inside of the mouthpiece.

The pressurized container should not be forced open, punctured or exposed

to temperatures above 50 °C.

IMPORTANT:

The mouthpiece was developed specifically for use with this inhaler to

ensure that the correct dose is always released. It should not therefore

be used with any other metered dose inhalers. Likewise, no mouthpieces

should be used with the inhaler other than the one provided.

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Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

7-1-2019

Enforcement Report for the Week of January 02, 2019

Enforcement Report for the Week of January 02, 2019

Recently Updated Records for the Week of January 02, 2019 Last Modified Date: Monday, January 07, 2019

FDA - U.S. Food and Drug Administration

18-12-2018


eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

Europe - EMA - European Medicines Agency

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

Europe - EMA - European Medicines Agency

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 11/02/2019 to 13/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 11/02/2019 to 13/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 11/02/2019 to 13/02/2019

Europe - EMA - European Medicines Agency

7-11-2018

Enforcement Report for the Week of November 07, 2018

Enforcement Report for the Week of November 07, 2018

Recently Updated Records for the Week of November 07, 2018 Last Modified Date: Friday, November 02, 2018

FDA - U.S. Food and Drug Administration

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl 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 confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

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

27-9-2018

Enforcement Report for the Week of November 02, 2016

Enforcement Report for the Week of November 02, 2016

Recently Updated Records for the Week of November 02, 2016 Last Modified Date: Thursday, September 27, 2018

FDA - U.S. Food and Drug Administration

11-1-2019


Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Europe - EMA - European Medicines Agency

20-12-2018

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (Active substance: glycopyrronium bromide / formoterol) - New authorisation - Commission Decision (2018)9127 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4245

Europe -DG Health and Food Safety

14-12-2018


Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide,  13/12/2018,  Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Active substance: Nanoliposomal irinotecan) - Transfer of orphan designation - Commission Decision (2018)8625 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/11/T/02

Europe -DG Health and Food Safety

29-11-2018


Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Europe - EMA - European Medicines Agency

28-11-2018

Anoro Ellipta (Glaxo Group Ltd)

Anoro Ellipta (Glaxo Group Ltd)

Anoro Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Yearly update - Commission Decision (2018)8049 of Wed, 28 Nov 2018

Europe -DG Health and Food Safety

22-11-2018

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (Active substance: umeclidinium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7876 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2809/T/22

Europe -DG Health and Food Safety

22-11-2018


Orphan designation: 1-(2,2-difluoro-2H-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropane-1-carboxamide and ivacaftor (tezacaftor and ivacaftor), Treatment of cystic fibrosis, 27/02

Orphan designation: 1-(2,2-difluoro-2H-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropane-1-carboxamide and ivacaftor (tezacaftor and ivacaftor), Treatment of cystic fibrosis, 27/02

Orphan designation: 1-(2,2-difluoro-2H-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropane-1-carboxamide and ivacaftor (tezacaftor and ivacaftor), Treatment of cystic fibrosis, 27/02/2017, Positive

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

16-11-2018

Incruse Ellipta (Glaxo Group Ltd)

Incruse Ellipta (Glaxo Group Ltd)

Incruse Ellipta (Active substance: umeclidinium bromide) - Centralised - Yearly update - Commission Decision (2018)7676 of Fri, 16 Nov 2018

Europe -DG Health and Food Safety

16-11-2018

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7673 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3754/T/26

Europe -DG Health and Food Safety

14-11-2018

Laventair Ellipta (Glaxo Group Ltd)

Laventair Ellipta (Glaxo Group Ltd)

Laventair Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Yearly update - Commission Decision (2018)7611 of Wed, 14 Nov 2018

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/01/075 (Eisai GmbH)

EU/3/01/075 (Eisai GmbH)

EU/3/01/075 (Active substance: Denileukin diftitox) - Transfer of orphan designation - Commission Decision (2018)6991 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/038/01/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/05/264 (Roche Registration GmbH)

EU/3/05/264 (Roche Registration GmbH)

EU/3/05/264 (Active substance: Cholest-4-en-3-one, oxime) - Transfer of orphan designation - Commission Decision (2018)6995 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/081/04/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

2-10-2018

Zavesca (Janssen-Cilag International NV)

Zavesca (Janssen-Cilag International NV)

Zavesca (Active substance: Miglustat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5472 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000435/T/0063

Europe -DG Health and Food Safety

2-10-2018

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Active substance: Parecoxib ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6471 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000381/T/0073

Europe -DG Health and Food Safety

2-10-2018

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Active substance: epoetin zeta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6481 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/872/T/86

Europe -DG Health and Food Safety

2-10-2018

HALAVEN (Eisai GmbH)

HALAVEN (Eisai GmbH)

HALAVEN (Active substance: eribulin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6457 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2084/T/46

Europe -DG Health and Food Safety

2-10-2018

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Active substance: Lamivudine) - Centralised - Yearly update - Commission Decision (2018)6476 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

2-10-2018

Intuniv (Shire Pharmaceuticals Ireland Limited)

Intuniv (Shire Pharmaceuticals Ireland Limited)

Intuniv (Active substance: guanfacine) - Centralised - Yearly update - Commission Decision (2018)6473 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Active substance: esomeprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6474 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002618/T/0023

Europe -DG Health and Food Safety

2-10-2018

Ritemvia (Celltrion Healthcare Hungary Kft.)

Ritemvia (Celltrion Healthcare Hungary Kft.)

Ritemvia (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6480 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Uptravi (Janssen-Cilag International NV)

Uptravi (Janssen-Cilag International NV)

Uptravi (Active substance: selexipag) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6470 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3774/T/19

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Metalyse (Boehringer Ingelheim International GmbH)

Metalyse (Boehringer Ingelheim International GmbH)

Metalyse (Active substance: tenecteplase) - Centralised - Yearly update - Commission Decision (2018)6489 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

2-10-2018

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Active substance: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone) - Transfer of orphan designation - Commission Decision (2018)6436 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/163/13/T/01

Europe -DG Health and Food Safety

2-10-2018

Trizivir (ViiV Healthcare BV)

Trizivir (ViiV Healthcare BV)

Trizivir (Active substance: abacavir, lamivudine, zidovudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6483 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/338/T/108

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Telzir (ViiV Healthcare BV)

Telzir (ViiV Healthcare BV)

Telzir (Active substance: Fosamprenavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6468 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/534/T/93

Europe -DG Health and Food Safety

2-10-2018

Pemetrexed Pfizer (Pfizer Europe MA EEIG)

Pemetrexed Pfizer (Pfizer Europe MA EEIG)

Pemetrexed Pfizer (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6464 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4488/T/04

Europe -DG Health and Food Safety

2-10-2018

Rebetol (Merck Sharp and Dohme B.V.)

Rebetol (Merck Sharp and Dohme B.V.)

Rebetol (Active substance: ribavirin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6479 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/246/T83

Europe -DG Health and Food Safety

2-10-2018

PegIntron (Merck Sharp and Dohme B.V.)

PegIntron (Merck Sharp and Dohme B.V.)

PegIntron (Active substance: Peginterferon alfa-2b) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6484 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/280/T/135

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Docetaxel Teva (Teva B.V.)

Docetaxel Teva (Teva B.V.)

Docetaxel Teva (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)6463 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Xigduo (AstraZeneca AB)

Xigduo (AstraZeneca AB)

Xigduo (Active substance: dapagliflozin/metformin) - Centralised - Renewal - Commission Decision (2018)6462 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2672/R/44

Europe -DG Health and Food Safety

2-10-2018

Vfend (Pfizer Europe MA EEIG)

Vfend (Pfizer Europe MA EEIG)

Vfend (Active substance: voriconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6490 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000387/T/0130

Europe -DG Health and Food Safety

2-10-2018

EU/3/11/909 (Janssen-Cilag International NV)

EU/3/11/909 (Janssen-Cilag International NV)

EU/3/11/909 (Active substance: Macitentan) - Transfer of orphan designation - Commission Decision (2018)6429 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/023/11/T/01

Europe -DG Health and Food Safety

2-10-2018

Vimizim (BioMarin International Limited)

Vimizim (BioMarin International Limited)

Vimizim (Active substance: elosulfase alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6491 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002779/T/0026

Europe -DG Health and Food Safety

2-10-2018

CoAprovel (Sanofi Clir SNC)

CoAprovel (Sanofi Clir SNC)

CoAprovel (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6465 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Celsentri (ViiV Healthcare BV)

Celsentri (ViiV Healthcare BV)

Celsentri (Active substance: maraviroc) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6467 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/811/T/56

Europe -DG Health and Food Safety

2-10-2018

ViraferonPeg (Merck Sharp and Dohme B.V.)

ViraferonPeg (Merck Sharp and Dohme B.V.)

ViraferonPeg (Active substance: Peginterferon alfa-2b) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6477 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/329/T/128

Europe -DG Health and Food Safety

2-10-2018

IntronA (Merck Sharp and Dohme B.V.)

IntronA (Merck Sharp and Dohme B.V.)

IntronA (Active substance: Interferon alfa-2b) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6487 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/281/T/116

Europe -DG Health and Food Safety

1-10-2018

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Active substance: Icatibant acetate) - Transfer of orphan designation - Commission Decision (2018)6432 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/02/T/01

Europe -DG Health and Food Safety