NortriTABS

Main information

  • Trade name:
  • NortriTABS nortriptyline (as hydrochloride) 25 mg uncoated tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NortriTABS nortriptyline (as hydrochloride) 25 mg uncoated tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220985
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220985

NortriTABS nortriptyline (as hydrochloride) 25 mg uncoated tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Amdipharm Mercury Australia Pty Ltd

Postal Address

PO Box 333,NORTH SYDNEY, NSW, 2059

Australia

ARTG Start Date

2/04/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. NortriTABS nortriptyline (as hydrochloride) 25 mg uncoated tablet bottle

Product Type

Single Medicine Product

Effective date

11/11/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of major depression

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

36 Months

Store below 25

degrees Celsius

Child resistant closure

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. NortriTABS nortriptyline (as hydrochloride) 25 mg uncoated tablet bottle

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White to off white, round, biconvex, uncoated tablets, debossed 'NM' on

one side and '25' on other side

Active Ingredients

Nortriptyline hydrochloride

28.5 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 01:45:17 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Summary of Product characteristics

NortriTABS PRODUCT INFORMATION ver 3.0

Page 1 of 8

NortriTABS

NAME OF THE MEDICINE

nortriptyline hydrochloride

Nortriptyline hydrochloride is a 5-(3-methylamino-propylidene)- 10,11-dihydro- 5H-dibenzo [a,d]

cycloheptene hydrochloride. Its molecular weight is 299.8 and its empirical formula is C

N.HCl.

The structural formula is as follows:

CAS number: 894-71-3

DESCRIPTION

NortriTABS 10 mg and 25 mg tablets contain 10 mg and 25 mg nortriptyline (present as the

hydrochloride) as the active ingredient, respectively.

Excipients include maize starch, magnesium stearate and lactose monohydrate.

PHARMACOLOGY

Actions

The mechanism of mood elevation by such tricyclic antidepressants is at present unknown.

Nortriptyline is not a monoamine oxidase inhibitor. It inhibits the activity of such diverse agents as

histamine, 5-hydroxytryptamine and acetylcholine. It increases the pressor effect of noradrenaline

but blocks the pressor effect of phenethylamine. Studies suggest that nortriptyline interferes with

the transport, release and storage of catecholamines. Operant conditioning techniques in rats and

pigeons suggest that nortriptyline has a combination of stimulant and depressant properties.

INDICATIONS

NortriTABS is indicated for the treatment of major depression.

CONTRAINDICATIONS

The use of nortriptyline or other tricyclic antidepressants concurrently with a monoamine oxidase

(MAO) inhibitor is contraindicated. Hyperpyretic crises, severe convulsions and fatalities have

occurred when similar tricyclic antidepressants were used in such combinations. It is advisable to

have discontinued the MAO inhibitor for at least two weeks before treatment with nortriptyline is

started.

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Page 2 of 8

Patients hypersensitive to nortriptyline should not be given the drug.

Cross sensitivity between nortriptyline and other dibenzazepines is a possibility.

Nortriptyline is contraindicated during the acute recovery period after myocardial infarction.

PRECAUTIONS

Clinical worsening and suicide risk associated with psychiatric disorders

The risk of suicide attempt is inherent in depression and may persist until significant remission

occurs. This risk must be considered in all depressed patients.

Patients with depression may experience worsening of their depressive symptoms and/or the

emergence of suicidal ideation and behaviours (suicidality) whether or not they are taking

antidepressant medications, and this risk may persist until significant remission occurs. As

improvement may not occur during the first few weeks or more of treatment, patients should be

closely monitored for clinical worsening and suicidality, especially at the beginning of a course of

treatment, or at the time of dose changes, either increases or decreases.

Consideration should be given to changing the therapeutic regimen, including possibly

discontinuing the medication, in patients whose depression is persistently worse or whose

emergent suicidality is severe, abrupt in onset, or was not part of the patient’s presenting

symptoms. Patients (and caregivers of patients) should be alerted about the need to monitor for

any worsening of their condition and/or the emergence of suicidal ideation/behaviour or thoughts of

harming themselves and to seek medical advice immediately if these symptoms present. Patients

with co-morbid depression associated with other psychiatric disorders being treated with

antidepressants should be similarly observed for clinical worsening and suicidality.

Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal

ideation prior to commencement of treatment, are at greater risk of suicidal thoughts or suicide

attempts, and should receive careful monitoring during treatment.

Pooled analyses of 24 short-term (4 to 16 weeks), placebo-controlled trials of nine antidepressant

medicines (SSRIs and other) in 4400 children and adolescents with major depressive disorder

trials), obsessive compulsive disorder (4 trials), or other psychiatric disorders (4 trials) have

revealed a greater risk of adverse events representing suicidal behaviour or thinking (suicidality)

during the first few months of treatment in those receiving antidepressants. The average risk of

such events in patients treated with an antidepressant was 4% compared with 2% of patients given

placebo. There was considerable variation in risk among the antidepressants, but there was a

tendency towards an increase for almost all antidepressants studied. The risk of suicidality was

most consistently observed in the major depressive disorder trials, but there were signals of risk

arising from trials in other psychiatric indications (obsessive compulsive disorder and social anxiety

disorder) as well. No suicides occurred in these trials. It is unknown whether the suicidality risk in

children and adolescent patients extends to use beyond several months. The nine antidepressant

medicines in the pooled analyses included five SSRIs (citalopram, fluoxetine, fluvoxamine,

paroxetine, sertraline) and four non-SSRIs (bupropion, mirtazapine, nefazodone, venlafaxine).

Pooled analysis of short term studies of antidepressant medications have also shown an increased

risk of suicidal thinking and behaviour, known as suicidality, in young adults ages 18 to 24 during

initial treatment (generally the first one to two months). Short term studies did not show an increase

in the risk of suicidality with antidepressants compared to placebo in adults beyond the age of

24 years; there was a reduction with antidepressants compared to placebo in adults aged 65 years

and older.

NortriTABS PRODUCT INFORMATION ver 3.0

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Symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness),

impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in

adults, adolescents and children being treated with antidepressants for major depressive disorder

as well as for other indications, both psychiatric and non-psychiatric. Although a causal link

between the emergence of such symptoms and either worsening of depression and/or emergence

of suicidal impulses has not been established, there is concern that such symptoms may be

precursors of emerging suicidality.

Families and caregivers of children and adolescents being treated with antidepressants for major

depressive disorder and for any other condition (psychiatric or non-psychiatric) should be informed

about the need to monitor these patients for the emergence of agitation, irritability, unusual

changes in behaviour, and other symptoms described above, as well as the emergence of

suicidality, and to report such symptoms immediately to health care providers. It is particularly

important that monitoring be undertaken during the initial few months of antidepressant treatment

or at times of dose increase or decrease.

Bipolar disorder and activation of mania/hypomania

A major depressive episode may be the initial presentation of bipolar disorder. It is generally

believed that treating such an episode with an antidepressant alone can increase the likelihood of

precipitation of a mixed/manic episode in patients at risk of bipolar disorder. Prior to initiating

treatment with an antidepressant, patients should be adequately screened to determine if they are

at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a

family history of suicide, bipolar disorder and depression.

Prescriptions for NortriTABS should be written for the smallest quantity of tablets consistent with

good patient management, in order to reduce the risk of overdose.

Patients with cardiovascular disease should be given nortriptyline only under close supervision

because of the tendency of the drug to produce sinus tachycardia and to prolong the conduction

time. Myocardial infarction, arrhythmia and strokes have occurred.

The antihypertensive action of guanethidine and similar agents may be blocked.

Because of its anticholinergic activity, nortriptyline should be used with great caution in patients

with glaucoma or a history of urinary retention.

Patients with a history of seizures should be followed closely when NortriTABS is administered,

since this drug is known to lower the convulsive threshold.

Great care is required if nortriptyline is administered to hyperthyroid patients or to those receiving

thyroid medication, since cardiac arrhythmias may develop.

Impairment of motor co-ordination

Nortriptyline may impair the mental and/or physical abilities required for the performance of

hazardous tasks, such as operating machinery or driving a car; therefore, the patient should be

warned accordingly.

Excessive consumption of alcohol in combination with nortriptyline therapy may have a potentiating

effect, which may lead to the danger of increased suicide attempts or overdosage, especially in

patients with histories of emotional disturbances or suicidal ideation. The patient should be

informed that the response to alcohol may be exaggerated.

Use in pregnancy

Pregnancy Category C. Tricyclic antidepressants have not been shown to be associated with an

increased incidence of birth defects. However, there is evidence of interference with central

NortriTABS PRODUCT INFORMATION ver 3.0

Page 4 of 8

monoamine neurotransmission in rats. Care should be taken that there are sound indications for

the use of these antidepressants in pregnancy.

Safe use of nortriptyline during pregnancy and lactation has not been established; therefore, when

the drug is administered to pregnant patients, nursing mothers, or women of childbearing age, the

potential benefits must be weighed against the possible hazards.

Animal reproduction studies have yielded inconclusive results.

Daily feeding of nortriptyline at a diet level of 0.05 percent from Day 5 to Day 20 of the gestation

period had no deleterious effects on foetal development of rabbits. Rats fed diets containing the

equivalent of 30 mg per kg daily from the time of weaning until maturity and during breeding

studies showed no indications of teratogenesis in the foetuses of two litters.

Paediatric use

The safety and efficacy of nortriptyline for the treatment of depression or other psychiatric disorders

in children and adolescents aged less than 18 years has not been satisfactorily established.

Nortriptyline should not be used in this age group for the treatment of depression or other psychiatric

disorders.

The use of nortriptyline in schizophrenic patients may result in an exacerbation of the psychosis or

may activate latent schizophrenic symptoms.

If the drug is given to overactive or agitated patients, increased anxiety and agitation may occur.

In manic depressive patients, nortriptyline may cause symptoms of the manic phase to emerge.

Troublesome patient hostility may be aroused by the use of nortriptyline.

Epileptiform seizures may accompany its administration, as is true of other drugs of its class.

When it is essential, the drug may be administered with electroconvulsive therapy, although the

hazards may be increased. Discontinue the drug for several days, if possible, prior to elective

surgery.

The possibility of a suicidal attempt by depressed patients remains after the initiation of treatment;

in this regard, it is important that the least possible quantity of drug be dispensed at any given time.

Both elevation and lowering of blood sugar levels have been reported.

INTERACTIONS WITH OTHER MEDICINES

Steady-state serum concentrations of the tricyclic antidepressants are reported to fluctuate

significantly as cimetidine is either added or deleted from the drug regimen. Serious anticholinergic

symptoms (severe dry mouth, urinary retention, blurred vision) have been associated with

elevations in the serum levels of the tricyclic antidepressant when cimetidine is added to the drug

regimen. In addition, higher than expected steady-state serum concentrations of the tricyclic

antidepressant have been observed when therapy is initiated in patients already taking cimetidine.

Alternatively, decreases in the steady-state serum concentration of the tricyclic antidepressant

have been reported in well-controlled patients on concurrent therapy, on discontinuance of

cimetidine. The therapeutic efficacy of the tricyclic antidepressant may be compromised in these

patients as cimetidine is discontinued. Several of the tricyclic antidepressants have been cited in

these reports.

NortriTABS PRODUCT INFORMATION ver 3.0

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There have been greater than two-fold increases in previously stable plasma levels of other

antidepressants, including nortriptyline, when PROZAC 20 (fluoxetine hydrochloride) has been

administered in combination with these agents. Fluoxetine and its active metabolite, norfluoxetine,

have a long half-life (4 to 16 days for norfluoxetine) which might affect strategies during conversion

from one drug to the other.

Administration of reserpine during therapy with a tricyclic antidepressant has been shown to

produce a "stimulating" effect in some depressed patients. Close supervision and careful

adjustment of the dosage are required when nortriptyline is used with other anticholinergic drugs

and sympathomimetic drugs.

A case of significant hypoglycaemia has been reported in a Type II diabetic patient maintained on

chlorpropamide (250 mg/day) after the addition of nortriptyline (125 mg/day).

The concomitant administration of quinidine and nortriptyline may result in a significantly longer

plasma half-life, higher AUC and lower clearance of nortriptyline.

Guanethidine and similar agents, thyroid medication, alcohol - see PRECAUTIONS.

Drugs metabolised by P450IID6

A subset (3% to 10%) of the population has reduced activity of certain drug metabolising enzymes

such as cytochrome P450 isoenzyme P450IID6. Such individuals are referred to as "poor

metabolisers" of drugs such as debrisoquin, dextromethorphan and the tricyclic antidepressants.

These individuals may have higher than expected plasma concentrations of tricyclic

antidepressants when given usual doses. In addition, certain drugs that are metabolised by this

isoenzyme, including many antidepressants (tricyclic antidepressants, selective serotonin reuptake

inhibitors and others), may inhibit the activity of this isoenzyme, and thus may make normal

metabolisers resemble poor metabolisers with regard to concomitant therapy with other drugs

metabolised by this enzyme system, leading to drug interactions.

Concomitant use of tricyclic antidepressants with other drugs metabolised by cytochrome P450IID6

may require lower doses than usually prescribed for either the tricyclic antidepressant or the other

drug. Therefore, co-administration of tricyclic antidepressants with other drugs that are metabolised

by this isoenzyme, including other antidepressants, phenothiazines, carbamazepine and Type 1C

antiarrhythmics (e.g. propafenone, flecainide and encainide), or that inhibit this enzyme (e.g.

quinidine), should be approached with caution.

ADVERSE EFFECTS

Included in the following list are a few adverse reactions that have not been reported with this

specific drug. However, the pharmacologic similarities among the tricyclic antidepressant drugs

require that each of the reactions be considered when nortriptyline is administered.

Cardiovascular - Hypotension, hypertension, tachycardia, palpitation, myocardial infarction,

arrhythmias, heart block, stroke.

Psychiatric - Confusional states (especially in the elderly) with hallucinations, disorientation,

delusions; anxiety, restlessness, agitation; insomnia, panic, nightmares; hypomania; exacerbation

of psychosis.

Neurological - Numbness, tingling, paraesthesias of extremities; incoordination, ataxia, tremors;

peripheral neuropathy; extrapyramidal symptoms; seizures, alteration in EEG patterns; tinnitus.

Anticholinergic - Dry mouth and, rarely, associated sublingual adenitis or gingivitis; blurred vision,

disturbance of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed

micturition, dilation of the urinary tract.

NortriTABS PRODUCT INFORMATION ver 3.0

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Allergic - Skin rash, petechiae, urticaria, itching, photosensitisation (avoid excessive exposure to

sunlight); oedema (general or of face and tongue), drug fever, cross sensitivity with other tricyclic

drugs.

Haematologic - Bone marrow depression, including agranulocytosis; aplastic anaemia;

eosinophilia; purpura; thrombocytopenia.

Gastrointestinal - Nausea and vomiting, anorexia, epigastric distress, diarrhoea; peculiar taste,

stomatitis, abdominal cramps, black tongue, constipation, paralytic ileus.

Endocrine - Gynaecomastia in the male; breast enlargement and galactorrhoea in the female;

increased or decreased libido, impotence; testicular swelling; elevation or depression of blood

sugar levels; syndrome of inappropriate ADH (antidiuretic hormone) secretion.

Other

- Jaundice (simulating obstructive); altered liver function, hepatitis and liver necrosis; weight

gain or loss; perspiration; flushing; urinary frequency, nocturia; drowsiness, dizziness, weakness,

fatigue; headache; parotid swelling; alopecia.

Withdrawal symptoms - Though these are not indicative of addiction, abrupt cessation of treatment

after prolonged therapy may produce nausea, headache, and malaise.

DOSAGE AND ADMINISTRATION

NortriTABS is not recommended for children.

NortriTABS is administered orally in the form of tablets. Lower than usual dosages are

recommended for elderly patients and adolescents. The dosage for outpatients should also be

lower than that for hospitalised patients who will be under close supervision. The physician should

initiate dosage at a low level and increase it gradually, noting carefully the clinical response and

any evidence of intolerance. Following remission, maintenance medication may be required for a

longer period of time at the lowest dose that will maintain remission.

If a patient develops minor adverse reactions, the dosage should be reduced. The drug should be

discontinued promptly if adverse effects of a serious nature or allergic manifestations occur.

Usual adult dose

25 mg 3 or 4 times daily; dosage should begin at a low level and be increased as required. Doses

above 100 mg per day are not recommended.

Use in children and adolescents (<18 years)

The safety and efficacy of nortriptyline for the treatment of depression or other psychiatric

disorders in children and adolescents aged less than 18 years has not been satisfactorily

established. Nortriptyline should not be used in this age group for the treatment of depression or

other psychiatric disorders (see PRECAUTIONS).

Elderly patients

25 to 50 mg per day, in divided doses.

Plasma levels

Optimal responses to nortriptyline have been associated with plasma concentrations of 50 to

150 mcg/L. Higher concentrations may be associated with more adverse experiences. Plasma

concentrations are difficult to measure, and physicians should consult with the laboratory

professional staff.

NortriTABS PRODUCT INFORMATION ver 3.0

Page 7 of 8

Older patients have been reported to have larger plasma concentrations of the active nortriptyline

metabolite 10-hydroxy-nortriptyline. In one case, this was associated with apparent cardiotoxicity

despite nortriptyline concentrations within the "therapeutic range". Clinical findings should

predominate over plasma concentrations as primary determinants of dosage changes.

OVERDOSAGE

Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including

alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex

and changing, it is recommended that the physician contact a poison control centre for current

information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic

antidepressant overdose; therefore, hospital monitoring is required as soon as possible.

Manifestations

Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, convulsions

and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis

or width, are clinically significant indicators of tricyclic antidepressant toxicity. Other signs of

overdose may include: confusion, disturbed concentration, transient visual hallucinations, dilated

pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia,

hyperpyrexia or many of the symptoms listed under ADVERSE EFFECTS.

Treatment

In managing overdosage, consider the possibility of multiple drug overdoses, interaction among

drugs and unusual drug kinetics in your patient. Protect the patient's airway and support ventilation

and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs,

blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be

decreased by giving activated charcoal. Repeated doses of charcoal over time may hasten

elimination of some drugs that have been absorbed. Safeguard the patient's airway when

employing charcoal.

Ventricular arrhythmias, especially when accompanied by lengthened QRS intervals, may respond

to alkalinisation by hyperventilation or administration of sodium bicarbonate. It is important to

monitor and manage serum electrolyte levels. Refractory arrhythmias may respond to propranolol,

bretylium, or lidocaine (lignocaine). Quinidine and procainamide usually should not be used

because they may exacerbate arrhythmias and conduction already slowed by the overdosage.

Seizures may respond to diazepam. Phenytoin has pharmacologic properties that may be helpful

in dealing with both the seizures and cardiac rhythm disturbances of tricyclic antidepressant

overdose. Although the prophylactic use of phenytoin has been suggested, it is not yet of proven

value.

Diuresis and dialysis remove little of the tricyclic antidepressant present in the body of a patient

who has taken an overdose. Haemoperfusion is of unproven benefit. The patient who has taken a

tricyclic overdose should be monitored closely, at least until the QRS duration is normal.

For information on the management of overdose, contact the Poison Information Centre on 131126

(Australia).

PRESENTATION AND STORAGE CONDITIONS

NortriTABS 10 mg

White to off white, round, biconvex, uncoated tablets, debossed ‘NM’ on one side and ‘10’ on other

side.

HDPE bottles - pack of 100 tablets: AUST R 221001*

PA/Al/PVC/Al blisters - pack of 50 tablets: AUST R 220998

NortriTABS PRODUCT INFORMATION ver 3.0

Page 8 of 8

NortriTABS 25 mg

White to off white, round, biconvex, uncoated tablets, debossed ‘NM’ on one side and ‘25’ on other

side.

HDPE bottles - pack of 100 tablets: AUST R 220985*

PA/Al/PVC/Al blisters - pack of 50 tablets: AUST R 220997

*Not available in the Australian market.

Store below 25°C.

NAME AND ADDRESS OF THE SPONSOR

Amdipharm Mercury (Australia) Pty Ltd

Level 9, 76 Berry Street

North Sydney NSW 2060

POISON SCHEDULE OF THE MEDICINE

S4: Prescription Only Medicine

DATE OF FIRST INCLUSION IN THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS

(THE ARTG)

02 April 2015

DATE OF MOST RECENT AMENDMENT

07 November 2016

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Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Active substance: canagliflozin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)3463 of Wed, 30 May 2018

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Active substance: Ponatinib hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3141 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/212/14/T/02

Europe -DG Health and Food Safety

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety