Abilify

Main information

  • Trade name:
  • Abilify 20 mg Tablet
  • Dosage:
  • 20 mg
  • Pharmaceutical form:
  • Tablet
  • Units in package:
  • Blister pack, AL/Al - 5 tablets, 5 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Otsuka Pharmaceutical Co Ltd

Documents

Localization

  • Available in:
  • Abilify 20 mg Tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • ABILIFY is indicated of the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 12920
  • Authorization date:
  • 18-08-2006
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ABILIFY™

ABILIFY™

5mg, 10mg, 15mg, 20mg & 30mg tablet

Aripiprazole

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about ABILIFY. It does

not contain all the available

information. Some of the information

contained in this leaflet may not

apply to you.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking ABILIFY

against the benefits it is expected to

have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What ABILIFY is used

for

ABILIFY is a trade name

(manufacturer's name) for the

medicine aripiprazole (Ari-pip-rah-

zol).

ABILIFY belongs to a group of

medicines called antipsychotic agents

which improve the symptoms of

certain types of mental illness.

ABILIFY is used to treat symptoms

of schizophrenia.

ABILIFY may be given to treat acute

episodes of sustained upward mood

swings (mania) in adult patients with

Bipolar 1 Disorder. During mania,

patients experience episodes of

overactivity, elation or irritability.

Schizophrenia is a mental illness

with disturbances in thinking,

feelings and behaviour.

Bipolar disorder is a condition with

symptoms such as feeling "high",

having excessive amounts of energy,

needing much less sleep than usual,

talking very quickly with racing

ideas and sometimes severe

irritability.

Your doctor may have prescribed

ABILIFY for another reason. Ask

your doctor if you have any questions

about why ABILIFY has been

prescribed for you.

There is no evidence that ABILIFY

is addictive.

This medicine is available only with

a doctor's prescription.

ABILIFY is not recommended for

use in children under the age of 18,

as safety and efficacy have not been

established in this age group.

Before you take

ABILIFY

When you must not take it

Do not take ABILIFY if you have

an allergy to:

aripiprazole

any of the ingredients listed at the

end of this leaflet

Symptoms of an allergic reaction

include:

rash, itching or hives on the skin

shortness of breath, wheezing or

difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

Do not take ABILIFY after the

expiry or use by date printed on

the pack.

If you take this medicine after this

date has passed, it may not work as

well.

Do not take ABILIFY if the

packaging is torn or shows signs of

tampering.

If this is the case, return it to your

pharmacist.

If you are not sure whether you

should start taking ABILIFY, talk

to your doctor or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if

you have allergies to:

any other medicines

any other substances such as

foods, preservatives or dyes

Tell your doctor if you are

pregnant or intend to become

pregnant.

ABILIFY is not recommended for

use during pregnancy. If you need to

take ABILIFY during your

pregnancy, your doctor will discuss

with you the benefits and risks of

taking it. Babies exposed to

antipsychotics (including ABILIFY)

during the third trimester of

pregnancy are at risk of experiencing

shaking, muscle stiffness, difficulty

in feeding and/or withdrawal

symptoms. These symptoms may

ABILIFY™

resolve spontaneously or require

additional medical treatment.

Tell your doctor or pharmacist if

you are breast-feeding or plan to

breast-feed.

It is recommended that you do not

breast-feed while taking ABILIFY,

as it may pass into breast milk and

therefore there is a possibility that the

breast-fed baby may be affected.

Tell your doctor if you have, or

have had any medical conditions,

especially the following:

a reaction to some medicines with

a sudden increase in body

temperature, sweating, fast heart

beat, muscle stiffness and

fluctuating blood pressure, which

may lead to coma. This reaction

is called neuroleptic malignant

syndrome.

a reaction to some medicines with

abnormal movements of the

tongue, or other uncontrolled

movements of the mouth, tongue,

cheeks or jaw which may

progress to the arms and legs.

This reaction is called tardive

dyskinesia.

low blood pressure

problems with your heart or blood

vessels

epilepsy, seizures or fits

problems with your oesophagus

(food pipe) such as difficulty in

swallowing.

high blood sugar or diabetes

mellitus

Alzheimer's disease or dementia

alcohol or drug abuse or

dependence or a history of one of

these

venous thromboembolism or are

at risk of venous

thromboembolism

lactose intolerance

Tell your doctor if you have past

experience of excessive gambling.

Tell your doctor if you drink

alcohol.

Your doctor may advise you to avoid

alcohol as it can magnify the side-

effects of this medicine.

If you have not told your doctor or

pharmacist about any of the above,

tell them before you start taking

ABILIFY.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and ABILIFY may

interfere with each other. These

include:

medicines used to treat brain

disorders such as, anxiety,

depression, mood swings,

epilepsy or seizures, Parkinson's

disease or insomnia.

medicines used to treat high

blood pressure

medicines used to treat fungal

infections

medicines used to treat heart

rhythm disturbances

medicines used to treat bacterial

or viral infections

a medicine called cyclosporin (

Neoral

; Sandimmun

a medicine called cimetidine

(Tagamet

; Magicul

These medicines may be affected by

ABILIFY, or may affect how well it

works. Your doctor may need to

adjust your dose of Abilify or of the

other medicine.

Eating grapefruit or drinking

grapefruit juice may affect how

ABILIFY works.

Your doctor or pharmacist may have

more information on medicines to be

careful with or avoid while taking

ABILIFY.

How to take ABILIFY

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

Your doctor or pharmacist will tell

you how much you will need to take

each day. This will depend on your

condition and whether you are taking

any other medicines.

The label put on the carton by the

pharmacist will tell you how much

you should take.

If you do not understand the

instructions on the carton, ask

your doctor or pharmacist for

help.

How to take it

ABILIFY tablets should be

swallowed whole and washed down

with a glass of water.

Take ABILIFY at about the same

time each day.

Unless your doctor gives you other

directions, you should take ABILIFY

only once a day.

Taking the medicine at the same time

each day will have the best effect. It

will also help you remember when to

take it.

It does not matter whether you take

ABILIFY with or without food.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

Otherwise, take it as soon as you

remember, and then go back to

taking your medicine as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

ABILIFY™

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

How long to take it

Continue taking ABILIFY for as

long as your doctor tells you.

ABILIFY helps to control your

condition but does not cure it.

Therefore you must take ABILIFY

every day. Improvement in

symptoms may take several days to

some weeks to occur. Even if you

feel better do not stop taking

ABILIFY unless your doctor tells

you to.

If you take too much

(overdose)

Immediately telephone your doctor

or pharmacist or the Poisons

Information Centre (telephone

131126), or go to the Accident

Emergency Centre at your nearest

hospital, if you or anyone else may

have taken too much ABILIFY. Do

this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

While you are taking

ABILIFY

Things you must do

Tell any doctors, dentists or

pharmacists who are treating you

that you are taking ABILIFY.

If you are about to be started on

any new medicine, tell your doctor,

dentist and pharmacist that you

are taking ABILIFY.

If you plan to have any kind of

surgery that needs a general

anaesthetic, tell your doctor or

dentist that you are taking

ABILIFY.

If you become pregnant while

taking ABILIFY, tell your doctor

immediately.

Be sure to keep all of your doctor's

appointments so that your progress

can be checked.

Things you must not do

Do not give ABILIFY to anyone

else, even if their symptoms seem

similar or they have the same

condition as you.

Do not take ABILIFY to treat any

other complaints unless your

doctor or pharmacist tells you to.

Do not stop taking ABILIFY or

lower the dosage, even if you are

feeling better, without checking

with your doctor.

If you stop taking ABILIFY

suddenly your condition may worsen.

Do not take more of this medicine

and do not take it more often than

your doctor has ordered.

Things to be careful of

Make sure that you know how you

react to ABILIFY before you drive

a car, operate machinery or do

anything else that could be

dangerous if you are dizzy or light

headed or not alert.

ABILIFY may cause some people to

become drowsy or less alert than they

are normally or cause light-

headedness, dizziness or tiredness. If

this occurs do not undertake the

activity.

If ABILIFY makes you feel light-

headed, dizzy or faint, be careful

when getting up from a sitting or

lying position.

Getting up slowly may help.

Be careful when drinking alcohol

while taking ABILIFY.

Your doctor may suggest you avoid

alcohol while you are being treated

with ABILIFY.

Make sure you keep cool in hot

weather and keep warm in cool

weather.

ABILIFY may affect the way your

body reacts to temperature changes.

It may prevent sweating, even during

heatwaves. You may feel dizzy or

faint if you are too hot. To stay cool

in hot weather, try to do the

following:

wear light clothing

spend time in air-conditioned

environments (or keep windows

open and use electric fans)

drink plenty of water

take cool baths or showers and

avoid hot baths and saunas

try to restrict exercise or heavy

work to cool parts of the day

Side-Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

ABILIFY.

Like other medicines ABILIFY may

cause some unwanted side effects.

These are likely to vary from patient

to patient. ABILIFY is generally

well-tolerated and the side effects are

often hard to distinguish from disease

symptoms. It is important that you

tell your doctor as soon as possible

about any unwanted effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following side effects and

they worry you:

headache

indigestion

nausea

vomiting

insomnia

constipation

light-headedness

drowsiness

agitation

anxiety

inability to sit or stand still;

restless movement of the arms

and legs such as tapping,

ABILIFY™

marching in places, rocking,

crossing and uncrossing the legs.

These are the more common side

effects of ABILIFY

Tell your doctor if you notice the

following side effects:

feeling dizzy especially when

getting up from a lying or sitting

position

altered or increased sexual

interest

These side effects are uncommon.

high blood sugar (excessive thirst,

hunger and weakness) or the

onset or worsening of diabetes

This side effect is rare.

weight gain

weight loss

loss of appetite

excessive sweating

drowsiness

high blood pressure

chest pain

frequent infections such as fever,

severe chills, sore throat or mouth

ulcers

bleeding or bruising more easily

than normal

speech disorder

urinary incontinence

difficulty swallowing

hiccups

These side effects are very rare.

Tell your doctor if you have

obsessive (recurring) thoughts or

behaviours or trouble controlling

impulsive urges or while taking

ABILIFY.

Obsessive compulsive behaviours

(feeling the need to check things

repeatedly or having certain thoughts

repeatedly), gambling urges, sexual

urges, compulsive spending, binge or

compulsive eating and other urges

have occurred in some patients.

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following:

seizure, fits or convulsions.

fainting.

abnormal movements of the

tongue, or other uncontrolled

movements of the tongue, mouth,

cheeks, or jaw which may

progress to the arms and legs.

sudden increase in body

temperature, sweating, fast heart

beat, muscle stiffness, high blood

pressure and convulsions.

rash.

allergic reaction (rash, itching or

hives on the skin; shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body).

muscle pain, muscle weakness or

muscle stiffness.

inflammation of the pancreas,

severe upper stomach pain often

with nausea and vomiting.

disorder of body temperature

regulation resulting in low body

temperature or high body

temperature.

painful irreversible erection.

difficulty in passing urine.

yellowing of the skin and/or eyes,

also called jaundice with or

without nausea, vomiting, loss of

appetite, feeling generally unwell,

fever, itching and dark coloured

urine.

serious lung infection with fever,

chills, shortness of breath, cough,

chest pain and blood streaked

phlegm.

thoughts or talk about death or

suicide; thoughts or talk about

self-harm or doing harm to

others; any recent attempts at

self-harm; an increase in

aggressive behaviour, irritability

or agitation. If you or someone

you know is showing these signs

contact your doctor or a mental

health advisor right away or go to

the nearest hospital for treatment.

These are very serious side effects.

You may need urgent medical

attention or hospitalisation.

All of these side effects are very rare.

Other side effects not listed above

may occur in some patients.

Also, while taking ABILIFY, some

elderly patients with dementia have

suffered serious side effects such as a

"mini" stroke, stroke, pneumonia or

heart problems. These serious side

effects can be life threatening.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Do not be alarmed by this list of

possible side effects.

You may not experience any or only

some of them.

After using ABILIFY

Storage

Store ABILIFY in a cool place

where the temperature stays below

30°C.

Do not store it or any other

medicine in the bathroom. Do not

leave it in the car or on window

sills.

Heat and dampness can destroy some

medicines.

Keep it where young children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines. Do

not keep outdated medicine or

medicine no longer needed.

Disposal

If your doctor tells you to stop

taking ABILIFY or the medicine

has passed its expiry date, ask your

pharmacist what to do with any

leftover medicine.

Be sure that any discarded

medicine is out of the reach of

children.

ABILIFY™

Product Description

What it looks like

5mg ABILIFY tablets are blue,

rectangular with a bevel edge and are

marked on one side with "A-007"

and "5" (Not available in New

Zealand)

10mg ABILIFY tablets are pink,

rectangular with a bevel edge and are

marked on one side with "A-008"

and "10".

15mg ABILIFY tablets are yellow,

round with a bevel edge and are

marked on one side with "A-009"

and "15".

20mg ABILIFY tablets are white to

pale yellowish white, round with a

bevel edge and are marked on one

side with "A-010" and "20".

30mg ABILIFY tablets are pink,

round with a bevel edge and are

marked on one side with "A-011"

and "30".

ABILIFY tablets are packed in

aluminium blisters in a carton. Each

carton contains 30 tablets.

Ingredients

Active ingredients:

aripiprazole

Other ingredients:

lactose, starch - maize, cellulose -

microcrystalline,

hydroxypropylcellulose and

magnesium stearate. The following

colorants are also present in the

tablets:

5mg tablets - indigo carmine

CI73015 aluminium lake (not

available in New Zealand)

10mg tablets - iron oxide red

CI77491

15mg tablets - iron oxide yellow

CI77492

20mg tablets - no colourants

30mg tablets - iron oxide red

CI77491

ABILIFY does not contain sucrose,

gluten, tartrazine or any other azo

dyes.

Sponsored by

In Australia:

Otsuka Australia Pharmaceutical Pty

Level 20, Tower A, The Zenith

821 Pacific Highway

Chatswood NSW 2067

Tel: Toll Free 1800 059 606

In New Zealand:

Pharmacy Retailing (NZ) Ltd trading

as Healthcare Logistics

58 Richard Pearse Drive

Airport Oaks

Mangere

Auckland 2022

Tel: Toll free 0800 602 200

Registration Numbers -

Australia

AUST R 90925 - 5mg tablets

AUST R 90997 - 10mg tablets

AUST R 90998 - 15mg tablets

AUST R 90999 - 20mg tablets

AUST R 91000 - 30mg tablets

Date of Preparation September 2016

ABILIFY is a trademark of Otsuka

Pharmaceutical Co., Ltd.

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21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

FDA - U.S. Food and Drug Administration

20-11-2018

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Op 20 november zijn de vijf winnaars van de Innovation Challenge Energieneutrale Sportaccommodaties, vanuit het programma Sportinnovator, bekendgemaakt. De innovatieve ideeën voor energiebesparing bij sportaccommodaties hebben groen licht gekregen. Ze ontvangen hiervoor steun van het ministerie van Volksgezondheid, Welzijn en Sport om innovatie in de sport te bevorderen. Onderstaande initiatieven krijgen 100.000 euro om het idee in de praktijk door te voeren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Theme event on big data and medicine

Theme event on big data and medicine

The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

Danish Medicines Agency

29-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

FDA - U.S. Food and Drug Administration

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

24-12-2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement for 16 November 2018 published

Therapeutic Goods Administration - Australia

21-12-2018

Consultation: Fees and charges proposal 2019-20

Consultation: Fees and charges proposal 2019-20

The TGA is seeking comments from interested parties on the proposed changes in fees and charges for 2019-2020. Closing date: 8 February 2018

Therapeutic Goods Administration - Australia

20-12-2018

Namuscla (Lupin Europe GmbH)

Namuscla (Lupin Europe GmbH)

Namuscla (Active substance: Mexiletine) - New authorisation - Commission Decision (2018)9133 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4584

Europe -DG Health and Food Safety

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

18-12-2018


Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

12-12-2018


Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Europe - EMA - European Medicines Agency

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

18-10-2018

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Active substance: Aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6925 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002755/T/0026

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency