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

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 HFA 134a), 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

.אפורל י/הנפ םייעובש ירחא תפלוח הניא העפותה םא .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

.קיזהל הלולע איה ,(ת)רחא הלוחב ;ךתלחמב לופיטל המשרנ וז הפורת

.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

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'

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 20 mcg

Inactive Ingredients

1,1,1,2-tetrafluoroethane (propellant HFA 134a), 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

treatment if 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 WILL THIS MEDICINE AFFECT YOUR DAILY LIFE?

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 as  cough 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’s instructions only.

Do not exceed the recommended dosage.

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

is not recommended for use in children under 6 years 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 use Atrovent Metered Aerosol".

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

for maximum benefit.

AVOID POISONING!

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.

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

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

.היפהמ לכימה תא דירפהל ןכמ רחאלו קבאה דגנ ןגמה

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.

To clean 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.

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

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

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

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

4-9-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Efavirenz/Emtricitabine/Tenofovir disoproxil Krka (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)5859 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4274/IB/02/G

Europe -DG Health and Food Safety

22-8-2018

CLYNAV (Elanco GmbH)

CLYNAV (Elanco GmbH)

CLYNAV (Active substance: Salmon pancreas disease vaccine (recombinant DNA plasmid)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5624 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2390/T/02

Europe -DG Health and Food Safety

7-8-2018

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5419 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5420 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Active substance: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA) - Orphan designation - Commission Decision (2018)5283 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2054 (Mallinckrodt Specialty Pharmaceuticals Ireland Limited)

EU/3/18/2054 (Mallinckrodt Specialty Pharmaceuticals Ireland Limited)

EU/3/18/2054 (Active substance: Tetracosactide) - Orphan designation - Commission Decision (2018)5286 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/043/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2047 (Glycomine SARL)

EU/3/18/2047 (Glycomine SARL)

EU/3/18/2047 (Active substance: Liposomal mannose-1-phosphate) - Orphan designation - Commission Decision (2018)5279 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/055/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2046 (Italfarmaco S.p.A.)

EU/3/18/2046 (Italfarmaco S.p.A.)

EU/3/18/2046 (Active substance: Givinostat) - Orphan designation - Commission Decision (2018)5278 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/062/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2044 (medac Gesellschaft fUr klinische SpezialprAparate mbH)

EU/3/18/2044 (medac Gesellschaft fUr klinische SpezialprAparate mbH)

EU/3/18/2044 (Active substance: Allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded) - Orphan designation - Commission Decision (2018)5276 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/023/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Active substance: 2'-O-(2-methoxyethyl) antisense oligonucleotide targeting microtubule-associated protein tau pre-mRNA) - Orphan designation - Commission Decision (2018)5273 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/050/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)5284 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2050 (AstraZeneca AB)

EU/3/18/2050 (AstraZeneca AB)

EU/3/18/2050 (Active substance: Selumetinib) - Orphan designation - Commission Decision (2018)5282 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/045/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/14/1351 (Kyowa Kirin Holdings B.V.)

EU/3/14/1351 (Kyowa Kirin Holdings B.V.)

EU/3/14/1351 (Active substance: Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23) - Transfer of orphan designation - Commission Decision (2018)5289 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/133/14/T/02

Europe -DG Health and Food Safety

2-8-2018

EU/3/16/1660 (Orchard Therapeutics Ltd)

EU/3/16/1660 (Orchard Therapeutics Ltd)

EU/3/16/1660 (Active substance: Autologous CD34+ cells transduced with lentiviral vector encoding the human beta globin gene) - Transfer of orphan designation - Commission Decision (2018)5288 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/024/16/T/02

Europe -DG Health and Food Safety

2-8-2018

EU/3/07/446 (Orchard Therapeutics Ltd)

EU/3/07/446 (Orchard Therapeutics Ltd)

EU/3/07/446 (Active substance: Autologous CD34+ cells transfected with lentiviral vector containing the human arylsulfatase A cDNA) - Transfer of orphan designation - Commission Decision (2018)5287 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/06/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/363 (Telix Pharmaceuticals Holdings Germany GmbH)

EU/3/06/363 (Telix Pharmaceuticals Holdings Germany GmbH)

EU/3/06/363 (Active substance: 4-[131I]iodo-L-phenylalanine) - Transfer of orphan designation - Commission Decision (2018)5036 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/05/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/04/192 (Celgene Europe B.V.)

EU/3/04/192 (Celgene Europe B.V.)

EU/3/04/192 (Active substance: 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione) - Transfer of orphan designation - Commission Decision (2018)5040 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/083/03/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/02/103 (Chiesi Farmaceutici S.p.A.)

EU/3/02/103 (Chiesi Farmaceutici S.p.A.)

EU/3/02/103 (Active substance: Recombinant Human Porphobilinogen Deaminase) - Transfer of orphan designation - Commission Decision (2018)5048 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/083/01/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/3/00/005 (Pfizer Europe MA EEIG)

EU/3/00/005 (Pfizer Europe MA EEIG)

EU/3/00/005 (Active substance: Gemtuzumab Ozogamicin) - Transfer of orphan designation - Commission Decision (2018)5037 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/022/00/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/14/1295 (Celgene Europe B.V.)

EU/3/14/1295 (Celgene Europe B.V.)

EU/3/14/1295 (Active substance: Marizomib) - Transfer of orphan designation - Commission Decision (2018)5063 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/035/14/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/420 (Pfizer Europe MA EEIG)

EU/3/06/420 (Pfizer Europe MA EEIG)

EU/3/06/420 (Active substance: Temsirolimus) - Transfer of orphan designation - Commission Decision (2018)5065 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/058/06/T/02

Europe -DG Health and Food Safety

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

19-7-2018

EU/3/16/1783 (Reglntel Ltd)

EU/3/16/1783 (Reglntel Ltd)

EU/3/16/1783 (Active substance: N-(5-(6-chloro-2,2-difluorobenzo[d][1,3]dioxol-5-yl)pyrazin-2-yl)-2-fluoro-6-methylbenzamide) - Transfer of orphan designation - Commission Decision (2018)4810 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/138/16/T/02

Europe -DG Health and Food Safety

18-7-2018

EU/3/16/1686 (Mereo Biopharma Ireland Ltd)

EU/3/16/1686 (Mereo Biopharma Ireland Ltd)

EU/3/16/1686 (Active substance: Recombinant humanised monoclonal IgG2 lambda antibody against human sclerostin) - Transfer of orphan designation - Commission Decision (2018)4809 of Wed, 18 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/16/T/02

Europe -DG Health and Food Safety

11-7-2018

Seebri Breezhaler (Novartis Europharm Limited)

Seebri Breezhaler (Novartis Europharm Limited)

Seebri Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4513 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2430/T/27

Europe -DG Health and Food Safety

11-7-2018

Tovanor Breezhaler (Novartis Europharm Limited)

Tovanor Breezhaler (Novartis Europharm Limited)

Tovanor Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4526 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2690/T/30

Europe -DG Health and Food Safety

4-7-2018

Enurev Breezhaler (Novartis Europharm Limited)

Enurev Breezhaler (Novartis Europharm Limited)

Enurev Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4342 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2691/T/27

Europe -DG Health and Food Safety

27-6-2018

EU/3/02/124 (BioMarin International Limited)

EU/3/02/124 (BioMarin International Limited)

EU/3/02/124 (Active substance: 3,4-diaminopyridine phosphate) - Transfer of orphan designation - Commission Decision (2018)4095 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/050/02/T/03

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/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

27-6-2018

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Active substance: (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3,4-dihydro-4-quinazolinyl} acetic acid) - Transfer of orphan designation - Commission Decision (2018)4102 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/10/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/07/509 (Celgene Europe B.V.)

EU/3/07/509 (Celgene Europe B.V.)

EU/3/07/509 (Active substance: Azacitidine) - Transfer of orphan designation - Commission Decision (2018)4086 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/085/07/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/01/084 (Celgene Europe B.V.)

EU/3/01/084 (Celgene Europe B.V.)

EU/3/01/084 (Active substance: Azacitidine) - Transfer of orphan designation - Commission Decision (2018)4083 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/059/01/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Active substance: Recombinant human monoclonal IgG1 antibody against programmed death ligand-1) - Transfer of orphan designation - Commission Decision (2018)4088 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/150/15/T/02

Europe -DG Health and Food Safety

14-6-2018

Incruse (Glaxo Group Ltd)

Incruse (Glaxo Group Ltd)

Incruse (Active substance: umeclidinium bromide) - Centralised - Yearly update - Commission Decision (2018)3855 of Thu, 14 Jun 2018

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

2-6-2018

EU/3/14/1350 (Novartis Europharm Limited)

EU/3/14/1350 (Novartis Europharm Limited)

EU/3/14/1350 (Active substance: Recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor) - Transfer of orphan designation - Commission Decision (2018)3630 of Sat, 02 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/14/T/01

Europe -DG Health and Food Safety