AFT - Metoprolol CR

Main information

  • Trade name:
  • AFT - Metoprolol CR 23.75 mg Modified release tablet
  • Dosage:
  • 23.75 mg
  • Pharmaceutical form:
  • Modified release tablet
  • Units in package:
  • Blister pack, PVC/PE/PVDC-aluminium blister 30 tablets, 30 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Moehs Catalana SL

Documents

Localization

  • Available in:
  • AFT - Metoprolol CR 23.75 mg Modified release tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • AFT - Metoprolol is indicated for the following indications:· Hypertension. To reduce blood pressure and to reduce the risk of cardiovascular and coronary mortality (including sudden death), and morbidity. · Angina pectoris. · Symptomatic mild to severe chronic heart failure as an adjunct to other heart failure therapy to: increase survival, reduce hospitalisation, improve left ventricular function, improve New York Heart Association (NYHA) functional class and improve Quality of Life. · Cardiac arrhythmias, especially supraventricular tachycardia, reduction of ventricular rate in atrial fibrillation and ventricular extrasystoles. · Maintenance treatment after myocardial infarction · Hyperthyroidism. · Functional heart disorder with palpitations. · Migraine prophylaxis.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 13194
  • Authorization date:
  • 18-06-2007
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

AFT-Metoprolol CR

Metoprolol succinate (Ph. Eur.) 23.75 mg, 47.5 mg, 95 mg and 190 mg

controlled-release tablets

Presentation

AFT-METOPROLOL CR tablets 23.75 mg are white, oval, biconvex, film-coated tablets

scored on both sides. Size 9 mm x 5 mm.

AFT-METOPROLOL CR tablets 47.5 mg are white, oval, biconvex, film-coated tablets scored

on both sides. Size 11 mm x 6 mm.

AFT-METOPROLOL CR tablets 95 mg are white, oval, biconvex, film-coated tablets scored

on both sides. Size 16 mm x 8 mm.

AFT-METOPROLOL CR tablets 190 mg are white, oval, biconvex, film-coated tablets scored

on both sides. Size 19 mm x 10 mm.

Uses

Actions

Metoprolol is a ß

-selective ß-blocker without significant-membrane stabilizing effect or

partial agonist activity.

Metoprolol reduces or inhibits the agonistic effect of catecholamines on the heart (which are

released during physical and mental stress). This means that the usual increase in heart

rate, cardiac output, cardiac contractility and blood pressure, produced by the acute increase

in catecholamines, is reduced by metoprolol. During high endogenous adrenaline levels

metoprolol interferes much less with blood pressure control than non-selective ß-blockers.

AFT-METOPROLOL CR gives a smoothed plasma concentration time and effect profile (ß

blockade) over 24 hours when compared to an immediate release ß

-selective blocker tablet

formulation.

AFT-METOPROLOL CR, when required to be used in combination with a ß

-agonist, may be

given to patients with symptoms of obstructive pulmonary disease. AFT-METOPROLOL CR

when given together with a ß

-agonist in therapeutic doses interferes less than non-selective

ß-blockers with the ß

-mediated broncho-dilation.

AFT-METOPROLOL CR has less effect on insulin release, carbohydrate metabolism and

cardiovascular response to hypoglycaemia than do non-selective ß-blockers.

Metoprolol may cause a slight increase in blood triglycerides, a decrease in blood free fatty

acids and sometimes a small decrease in the high density lipoproteins (HDL) fraction,

although less than that observed following non-selective ß-blockers. A long term study did

show a significant reduction in total serum cholesterol levels.

Quality of life is maintained or improved during treatment with metoprolol including for

patients with chronic heart failure or post myocardial infarction.

Effect in hypertension

AFT-METOPROLOL CR lowers elevated standing and supine blood pressure. A short

duration (a few hours) and clinically insignificant increase in peripheral resistance may be

observed after the institution of metoprolol treatment. During long-term treatment a reduction

in total peripheral resistance, left ventricular hypertrophy may occur and improved left

ventricular diastolic function and left ventricular filling.

A reduction in the risk of death from cardiovascular disease in men with mild to moderate

hypertension

metoprolol

been

shown,

mainly

reduced

risk

sudden

cardiovascular death, to reduce the risk for fatal and non-fatal infarction and for stroke.

Effect on angina pectoris

Metoprolol has been shown to reduce the frequency, duration and severity of both angina

attacks and silent ischemic episodes and to increase the physical working capacity in

patients with angina pectoris.

Effect in chronic heart failure

In patients with symptoms of heart failure (New York Heart Association (NYHA) II-IV) and

decreased ejection fraction (≤0.40) metoprolol, when added to standard therapy, has been

shown to improve survival and to reduce the number of hospitalisations due to worsening

heart failure. In addition, metoprolol therapy has increased ejection fraction, reduced left

ventricular end systolic and end diastolic volumes, improved NYHA functional class and

improved quality of life.

Effect on cardiac rhythm

AFT-METOPROLOL

controls

heart

rate

supraventricular

tachycardia

atrial

fibrillation, and in the presence of ventricular extrasystoles inhibits the cardiac effects of

increased sympathetic activity leading to decreased automaticity in the pacemaker cells and

reduction of supraventricular conduction velocity.

Effect on myocardial infarction

Metoprolol reduces the risk of sudden death in patients with suspected or confirmed

myocardial infarction. In high risk patients with diabetes mellitus or previous cardiovascular

disease there is a reduction in mortality.

Metoprolol has also been shown to reduce the risk for non-fatal myocardial infarction and to

reduce the incidence of recurrent myocardial infarction. There is a reduction in chest pain

during the acute infarction phase due to the anti-ischemic effects of metoprolol.

Effect on hyperthyroidism

Metoprolol can reduce the clinical effects of hyperthyroidism.

Effect on heart disorders with palpitations

AFT-METOPROLOL CR is effective in reducing palpitations and improving the patient's

general condition.

Effect on migraine

AFT-METOPROLOL CR is suitable for prophylactic treatment of migraine.

Pharmacokinetics

Absorption and distribution

Metoprolol is completely absorbed after oral administration. Due to extensive first-pass

metabolism the systemic bioavailability of metoprolol from a single oral dose is approximately

50%. Bioavailability is reduced by about 20-30% for the controlled release preparation

compared to the conventional tablets. The heart rate is the same as with conventional

tablets.

Plasma protein binding of metoprolol is about 5-10%. Volume of distribution of 5.6 L/kg.

AFT-metoprolol

consists

beads

of metoprolol

succinate coated

with a polymer

membrane

controlling

drug

release

rate

resulting

even

metoprolol

plasma

concentration over a 24 hour dose interval. There is consequently much less variation in

metoprolol

plasma

concentrations

pharmacological

effects

compared

with

conventional, immediate release tablet. Release rate is independent of physiological factors

such as pH, food and peristalsis.

Metabolism and elimination

Metoprolol undergoes oxidative metabolism in the liver primarily by the CYP2D6 isoenzyme.

Metabolites are inactive. The fraction excreted unchanged is usually about 5% and up to

30% in isolated cases.

Mean elimination half-life of metoprolol in plasma is 3.5 hours (range1-9 hours). Clearance

rate is approximately 1 litre/minute.

Pharmacokinetics of metoprolol are not effected by age.

Renal impairment does not effect the systemic bioavailability and elimination of metoprolol.

However in patients with a glomerular filtration rate (GFR) of less than 5 mL/minute,

significant accumulation of metabolites was observed.

Decreased liver function has little effect on metoprolol pharmacokinetics. Bioavailability

increases and total clearance may be reduced in patients with severe liver cirrhosis and a

portacaval

shunt.

Patients

with

portacaval

anastomosis

total

clearance

approximately 0.3 litres/minute and area under the plasma concentration-time curve (AUC)

values of up to 6 times higher than in healthy subjects.

Indications

Hypertension. To reduce blood pressure and to reduce the risk of cardiovascular and

coronary mortality (including sudden death), and morbidity.

Angina pectoris.

Symptomatic mild to severe chronic heart failure as an adjunct to other heart failure

therapy to: increase survival, reduce hospitalisation, improve left ventricular function,

improve New York Heart Association (NYHA) functional class and improve Quality of Life.

Cardiac arrhythmias, especially supraventricular tachycardia, reduction of ventricular rate

in atrial fibrillation and ventricular extrasystoles.

Maintenance treatment after myocardial infarction

Hyperthyroidism.

Functional heart disorder with palpitations.

Migraine prophylaxis.

Dosage and Administration

Dosage should always be adjusted to the patient's individual requirements.

AFT-METOPROLOL CR is recommended for once daily treatment, should be taken at the

same time of the day with regard to food and is preferably taken together with the morning

meal.

The tablets

broken

in half.

AFT-METOPROLOL CR

tablets

should be

swallowed with liquid and should not be chewed or crushed.

The following dosage recommendations may be taken as a guide:

Hypertension

recommended

dose

patients

with

mild

moderate

hypertension

47.5

metoprolol given once daily. In patients not responding to 47.5 mg the dose can be increased

to 95-190 mg once daily or combined with other antihypertensive agents.

Long-term antihypertensive treatment with metoprolol in daily doses of 95-190 mg has been

shown to reduce total mortality, including sudden cardiovascular death, stroke and coronary

events in hypertensive patients.

Angina Pectoris

The recommended dose is 95-190 mg daily given as a single dose in the morning. AFT-

METOPROLOL CR can be combined with other antianginal agents if needed.

Chronic Heart Failure

The dose of AFT-METOPROLOL CR should be adjusted in individual patients with chronic

heart failure stabilised on other heart failure treatment. A recommended initial dose during

the first two weeks is a 23.75 mg tablet once daily. It is recommended that patients with

NYHA functional classes III-IV begin with half a 23.75 mg tablet once daily for the first week.

It is recommended that the dose then be doubled every second week up to a maximum

target dose of 190 mg AFT-METOPROLOL CR once daily (or to the highest tolerated dose).

During long-term treatment the aim should be to reach 190 mg AFT-METOPROLOL CR

once daily (or the highest tolerated dose).

Tolerability

should

monitored

carefully

each

dose.

decrease

concomitant

medication may be necessary in cases of hypotension. However initial hypotension does not

necessarily mean that the dose cannot be tolerated in chronic treatment but the patient

should be stabilized at the lower dose first.

Cardiac Arrhythmias

95-190 mg daily, given as a single dose once daily.

Myocardial Infarction

Treatment in the acute stage

After symptoms indicating myocardial infarction, treatment with metoprolol administered

intravenously should be initiated as soon as possible. Such treatment should be initiated in a

coronary care or similar unit immediately after the patient's haemodynamic condition has

stabilised. Depending on the haemodynamic status of the patient (ECG, blood pressure,

heart rate), three 5 mg bolus injections should be given, at 2 minute intervals.

In patients who tolerate the full intravenous dose (15 mg), AFT-METOPROLOL CR tablets

47.5 mg four times daily should be started 15 minutes after the last intravenous injection and

be continued for 24 hours. Followed by AFT-METOPROLOL CR 95 mg twice daily for a

further 24 hours.

Patients who do not tolerate the full intravenous (15 mg) dose should have their oral

treatment initiated with caution starting with a lower dose.

Maintenance treatment after myocardial infarction

Long-term oral treatment with metoprolol-CR 190 mg once daily has been shown to reduce

the risk of death (including sudden death) and reinfarction (also in patients with diabetes

mellitus).

Functional heart disorder with palpitations

The recommended dosage is 95 mg once daily. If necessary, the dose may be increased to

190 mg.

Migraine prophylaxis

The recommended dosage is 95-190 mg once daily.

Hyperthyroidism

95-190 mg daily, given as a single dose in the morning. If necessary, the dose may be

increased.

Impaired Renal Function

Dose adjustment is not required in patients with impaired renal function.

Impaired Hepatic Function

Dose adjustment is not normally needed in patients suffering from liver cirrhosis although a

reduction in dose should be considered when there are signs of serious impairment of liver

function (e.g. shunt-operated patients).

Elderly

Dose adjustment is not needed.

Children

There is limited experience with metoprolol treatment in children.

Contraindications

Bronchial asthma or other obstructive lung disorders.

Grade 2 and 3 A-V block and intranodal A-V block.

Patients

with

unstable

decompensated

cardiac

heart

failure

(pulmonary

oedema,

hypoperfusion or hypotension), and patients with continuous or intermittent inotropic

therapy acting through ß-receptor agonism.

Marked clinically relevant sinus bradycardia.

Sick-sinus syndrome.

Cardiogenic shock.

Severe peripheral arterial circulatory disorder.

Metoprolol should not be given to patients with suspected acute myocardial infarction as

long as the heart rate is <45 beats/minute, the P-Q interval is > 0.24 seconds or the

systolic blood pressure is <100 mmHg.

AFT-METOPROLOL CR is contraindicated in patients who have shown hypersensitivity to

other ß–blockers or any of the tablet excipients.

Warnings and Precautions

Intravenous administration of calcium antagonists of the verapamil-type should not be given

to patients treated with ß-blockers.

risk

AFT-METOPROLOL

interfering

with

-receptors

less

than

with

conventional tablet formulations of ß

-selective blockers.

The risk of interfering with carbohydrate metabolism or masking hypoglycaemia is likely to be

less with AFT-METOPROLOL CR than with conventional tablet formulations of ß

-selective

blockers and much less than with non-selective ß-blockers.

Very

rarely

pre-existing

conduction

disorder

moderate

degree

become

aggravated (possibly leading to A-V block). If the patient develops increasing bradycardia,

AFT-METOPROLOL CR should be given in lower doses or gradually withdrawn.

AFT-METOPROLOL CR may aggravate the symptoms of peripheral arterial circulatory

disorders, mainly due to its blood pressure lowering effect.

Where AFT-METOPROLOL CR is prescribed for a patient known to be suffering from

phaeochromocytoma, an alpha-blocker should be co-administered.

It is not recommended to stop ß-blocker treatment in patients undergoing surgery but the

anaesthetist should be informed

Abrupt withdrawal of ß-blockade is hazardous especially in high risk patients, and should not

be done. If discontinuation of AFT-METOPROLOL CR is required, this should preferably be

done gradually over at least two weeks when the dose is halved in each step down to the

final step when a whole 23.75 mg tablet is reduced to half a tablet. Slower withdrawal rate is

recommended if symptoms occur. Sudden withdrawal of ß-blockade may aggravate chronic

heart failure and increases the risk for myocardial infarction and sudden death

In patients taking ß-blockers anaphylactic shock assumes a more severe form.

Use in pregnancy [Category C]

AFT-METOPROLOL CR should not be given during pregnancy and lactation unless its use is

considered essential. Beta-blockers may cause side effects (e.g. bradycardia) in the foetus,

newborn and breast-fed infant.

Use in lactation

At normal therapeutic doses, the amount of metoprolol ingested from breast milk is in general

minimal and insufficient to cause ß-blockade in the infant.

Effects on ability to drive and use machines

Since occasional dizziness or fatigue may occur, patients should know how they react to

AFT-METOPROLOL CR before driving or using machines.

Adverse Effects

Metoprolol

generally

well

tolerated.

Most

adverse

reactions

are generally

mild

transient.

The following adverse events have been reported mostly with conventional metoprolol

(metoprolol tartrate). In many cases a relationship to treatment with metoprolol has not been

established.

Cardiovascular system

Common: Bradycardia, postural disorders (very rarely with syncope). Cold hands and feet,

palpitations.

Uncommon: Deterioration of heart failure symptoms, cardiogenic shock in patients with

acute myocardial infarction, first degree heart block, oedema, precordial pain.

Rare: Disturbances of cardiac conduction, cardiac arrhythmias.

Very rare: Gangrene in patients with pre-existing severe peripheral circulatory disorders.

Central Nervous System

Very common: Fatigue

Common: Dizziness, headache.

Uncommon: Paraesthesiae, muscle cramps.

Gastrointestinal

Common: Nausea, abdominal pain, diarrhoea, constipation.

Uncommon: Vomiting

Rare: Dry mouth

Haematologic

Very rare: Thrombocytopenia

Hepatic

Rare: Liver function test abnormalities

Very rare: Hepatitis

Metabolism

Uncommon: Weight gain

Musculoskeletal

Very rare: Arthralgia

Psychiatric

Uncommon: Depression, impaired concentration, somnolence or insomnia, nightmares

Rare: Nervousness, anxiety, impotence and/or sexual dysfunction.

Very rare: Amnesia and/or memory impairment, confusion, hallucinations.

Respiratory

Common: Dyspnoea on exertion.

Uncommon: Bronchospasm

Rare: Rhinitis

Sense organs

Rare: Disturbances of vision, dry and/or irritated eyes, conjunctivitis

Very rare: Tinnitus, taste disturbances

Skin

Uncommon: Rash (in the form of urticaria psoriasiform and dystrophic skin lesions),

increased sweating.

Rare: Loss of hair

Very rare: Photosensitivity reactions, aggravated psoriasis.

Definition of frequencies:

very common: ≥10%

common: 1 - 9.9%,

uncommon: 0.1 - 0.9%

rare: 0.01 - 0.09%

very rare: <0.01%

Interactions

Metoprolol is a metabolic substrate for the cytochrome P450 isoenzyme CYP2D6. Potent

inhibitors of the CYP2D6 enzyme such as. antiarrhythmics, antihistamines, histamine-2-

receptor antagonists, antidepressants, antipsychotics or COX-2 inhibitors may therefore

increase the plasma concentration of metoprolol.

The plasma concentration of metoprolol is lowered by rifampicin and may be raised by

alcohol and hydralazine.

Patients receiving concomitant treatment with sympathetic ganglion blocking agents, other ß-

blockers (i.e. eye drops) or monoamine oxidase inhibitors should be kept under close

surveillance.

If a patient is treated with clonidine and metoprolol concurrently, and clonidine treatment is to

be discontinued, metoprolol should be stopped several days before clonidine is withdrawn.

Rebound hypertension that can follow withdrawal of clonidine may be increased in patients

receiving concurrent ß-blocker treatment.

Increased negative inotropic and chronotropic effects may occur when metoprolol is given

together with calcium antagonists of the verapamil and diltiazem type. Patients treated with

ß-blockers,should not be given calcium antagonists of the verapamil type parenterally.

Beta-blockers

enhance

negative inotropic

and negative dromotropic

effect of

antiarrythmic agents (of the quinidine type and amiodarone).

Both digitalis glycosides and ß blockers slow atrioventricular conduction and decrease heart

rate. Concomitant use can increase the risk of bradycardia.

Some inhalation anaesthetics may enhance the cardiodepressant effect of ß-blockers.

Concomitant treatment with indomethacin or other prostaglandin synthetase inhibiting agents

may decrease the antihypertensive effect of ß-blockers.

Under certain conditions, cardioselective ß-blockers interfere much less with blood pressure

control than non-selective ß-blockers when adrenaline is administered to patients treated

with ß-blockers,.

The dosages of oral antidiabetics may have to be readjusted in patients receiving ß-blockers.

Overdosage

Symptoms

Potential signs and symptoms associated with overdosage with metoprolol are: severe

hypotension,

sinus

bradycardia,

atrioventricular

block,

heart

failure,

cardiogenic

shock,

cardiac arrest, bronchospasm, impairment of consciousness and/or coma, nausea, vomiting

and cyanosis.

Concomitant ingestion of alcohol, antihypertensives, quinidine or barbiturates may aggravate

the patients condition.

The first symptoms of overdosage may be observed 20 minutes to 2 hours after ingestion.

Treatment

There is no specific antidote.

On the basis of the pharmacologic actions of metoprolol, the following general measures

should be employed:

Elimination of the Drug: Induction of vomiting or gastric lavage should be performed.

Bradycardia: Atropine should be administered. If there is no response to vagal blockade,

isoproterenol should be administered cautiously.

Hypotension: A vasopressor should be administered, e.g., levarterenol or dopamine.

Bronchospasm:

-stimulating

agent

and/or

theophylline

derivative

should

administered.

Cardiac Failure: A digitalis glycoside and diuretic should be administered. In shock resulting

from

inadequate

cardiac

contractility,

administration

dobutamine,

isoproterenol,

glucagon may be considered.

Pharmaceutical Precautions

Protect from light and moisture. Keep out of reach of children. Store below 25 °C.

Medicine Classification

Prescription Medicine.

Package Quantities

All strengths of AFT-METOPROLOL CR tablets are available in blister packs containing 30,

90, and 100 tablets and HDPE bottles containing 30 tablets.

Further Information

List

excipients:

ethylcellulose,

hydroxypropylmethyl

cellulose,

methylcellulose,

microcrystalline cellulose, glycerol, maize starch, magnesium stearate, stearic acid and

titanium dioxide (E 171).

Name and Address

AFT Pharmaceuticals Ltd

PO Box 33-203

Takapuna, Auckland

Ph: (09) 488-0232

Fax: (09) 488-0234

Date of Preparation

23 June 2016

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Health Canada

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

Operation Pangea XI reinforces the dangers of buying unauthorized health products online

Operation Pangea XI reinforces the dangers of buying unauthorized health products online

October 23, 2018 For immediate release

Health Canada

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 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 evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

27-7-2018

Pending EC decision:  Kalydeco, ivacaftor, Opinion date: 26-Jul-2018

Pending EC decision: Kalydeco, ivacaftor, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

27-7-2018

Pending EC decision:  Symkevi, tezacaftor / ivacaftor, Opinion date: 26-Jul-2018

Pending EC decision: Symkevi, tezacaftor / ivacaftor, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

25-7-2018

Kraft Heinz Voluntarily Recalls Taco Bell Salsa Con Queso Mild Cheese Dip Distributed to Retailers

Kraft Heinz Voluntarily Recalls Taco Bell Salsa Con Queso Mild Cheese Dip Distributed to Retailers

As a precaution, approximately 7,000 cases of Taco Bell Salsa Con Queso Mild Cheese Dip are being voluntarily recalled because the affected product is showing signs of product separation which can lead to a potential health hazard. This could create conditions that could allow for the growth of Clostridium botulinum (C. botulinum), a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

FDA - U.S. Food and Drug Administration

24-7-2018

July 23, 2018: Springfield EMT/Paramedic Pleads Guilty to Stealing Fentanyl, Morphine

July 23, 2018: Springfield EMT/Paramedic Pleads Guilty to Stealing Fentanyl, Morphine

July 23, 2018: Springfield EMT/Paramedic Pleads Guilty to Stealing Fentanyl, Morphine

FDA - U.S. Food and Drug Administration

18-1-2019


Ivabradine / metoprolol: List of nationally authorised medicinal products - PSUSA/00010381/201804

Ivabradine / metoprolol: List of nationally authorised medicinal products - PSUSA/00010381/201804

Ivabradine / metoprolol: List of nationally authorised medicinal products - PSUSA/00010381/201804

Europe - EMA - European Medicines Agency

18-12-2018


Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive

Europe - EMA - European Medicines Agency

28-11-2018

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Active substance: Lumacaftor/Ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8042 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3954/T/39

Europe -DG Health and Food Safety

28-11-2018

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Active substance: ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8047 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/T/71

Europe -DG Health and Food Safety

23-11-2018

Orfadin (Swedish Orphan Biovitrum International AB)

Orfadin (Swedish Orphan Biovitrum International AB)

Orfadin (Active substance: Nitisinone) - PSUSA - Modification - Commission Decision (2018)7890 of Fri, 23 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2169/201802

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

22-11-2018


Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Europe - EMA - European Medicines Agency

6-11-2018

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Authorisation - Commission Decision (2018)7415 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4682

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

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

24-9-2018

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Active substance: Choriogonadotrophin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6220 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/320/T/75

Europe -DG Health and Food Safety

19-9-2018

Fortacin (Recordati Ireland Ltd)

Fortacin (Recordati Ireland Ltd)

Fortacin (Active substance: lidocaine / prilocaine) - Centralised - Renewal - Commission Decision (2018)6103 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2693/R/23

Europe -DG Health and Food Safety

4-9-2018

Agenda:  Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda: Agenda - CHMP agenda of the 20-23 August 2018 written procedure

Agenda of CHMP written procedure*20-23 August 2018

Europe - EMA - European Medicines Agency

28-8-2018

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Active substance: ivacaftor) - PASS - Modification - Commission Decision (2018)5693 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/RSR/S/14

Europe -DG Health and Food Safety

28-8-2018

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

Orkambi (Vertex Pharmaceuticals (Europe) Limited)

Orkambi (Active substance: Lumacaftor/Ivacaftor) - PSUSA - Modification - Commission Decision (2018)5710 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10455/201711

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the CAT meeting 23-25 May 2018

Minutes of the CAT meeting 23-25 May 2018

Europe - EMA - European Medicines Agency

23-8-2018

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Active substance: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor) - Corrigendum - Commission Decision (2018)1246 of Thu, 23 Aug 2018

Europe -DG Health and Food Safety

23-8-2018

Public submissions on scheduling matters referred to the ACMS #23, ACCS #22 and Joint ACMS-ACCS #18 meetings held in March 2018

Public submissions on scheduling matters referred to the ACMS #23, ACCS #22 and Joint ACMS-ACCS #18 meetings held in March 2018

Public submissions on scheduling matters referred to ACMS/ACCS meetings held in March 2018

Therapeutic Goods Administration - Australia

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

30-7-2018

NovoEight (Novo Nordisk A/S)

NovoEight (Novo Nordisk A/S)

NovoEight (Active substance: turoctocog alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5093 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2719/II/23

Europe -DG Health and Food Safety

25-7-2018

Moventig (Kyowa Kirin Holdings B.V.)

Moventig (Kyowa Kirin Holdings B.V.)

Moventig (Active substance: naloxegol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4985 of Wed, 25 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2810/T/23

Europe -DG Health and Food Safety

23-7-2018

Agenda:  Agenda - HMPC agenda of the 23-24 July 2018 meeting

Agenda: Agenda - HMPC agenda of the 23-24 July 2018 meeting

Europe - EMA - European Medicines Agency

23-7-2018

Agenda:  Agenda - CHMP agenda of the 23-26 July 2018 meeting

Agenda: Agenda - CHMP agenda of the 23-26 July 2018 meeting

Europe - EMA - European Medicines Agency