APO-SERTRALINE

Main information

  • Trade name:
  • APO-SERTRALINE sertraline (as hydrochloride) 50mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-SERTRALINE sertraline (as hydrochloride) 50mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213177
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213177

APO-SERTRALINE sertraline (as hydrochloride) 50mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

27/09/2013

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. APO-SERTRALINE sertraline (as hydrochloride) 50mg tablet blister pack

Product Type

Single Medicine Product

Effective date

1/06/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Sertraline is indicated in adults for the treatment of 1) major depression; 2) social phobia (social anxiety disorder) and the prevention of its relapse; 3)

premenstrual dysphoric disorder (PMDD) as defined by DSM-IV criteria.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

48 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1. APO-SERTRALINE sertraline (as hydrochloride) 50mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off-white, capsule shaped, biconvex film coated tablets with '50'

and 'BL' embossed on either side of the breakline

Active Ingredients

Sertraline hydrochloride

55.95 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 11:31:07 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

Patient Information leaflet

APO-Sertraline Tablets

Contains the active ingredient sertraline (as sertraline hydrochloride)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about sertraline. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is APO-

Sertraline. It contains the active

ingredient sertraline (as sertraline

hydrochloride).

It is used to treat:

depression

social anxiety disorder or social

phobia

Pre-Menstrual Dysphoric

Disorder (PMDD)

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

Sertraline belongs to a group of

medicines called Selective Serotonin

Re-uptake Inhibitors (SSRIs).

Serotonin is one of the chemicals in

your brain which helps control your

mood. Sertraline and other SSRIs are

thought to help by increasing the

amount of serotonin in your brain.

Depression is longer lasting and/or

more severe than the "low moods"

everyone has from time to time due

to the stress of everyday life. It is

thought to be caused by a chemical

imbalance in parts of the brain. This

imbalance affects your whole body

and can cause emotional and physical

symptoms such as feeling low in

spirit, loss of interest in activities,

being unable to enjoy life, poor

appetite or overeating, disturbed

sleep, often waking up early, loss of

sex drive, lack of energy and feeling

guilty over nothing.

PMDD affects some women in the

days before their period. PMDD is

different from premenstrual

syndrome (PMS). The mood

symptoms (anger, sadness, tension,

etc.) in PMDD are more severe than

in PMS and affect the woman's daily

activities and relationship with

others.

There is no evidence that this

medicine is addictive.

Clinical experience has shown that

sertraline should not affect the ability

to drive or operate machinery.

However, make sure you know how

sertraline affects you before driving

or operating machinery, as it can

make some people drowsy or dizzy

or affect their concentration.

Use in children

This medicine should not be used in

children.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You are taking any of the

following medicines:

Pimozide (used to treat disorders

which affect the way you think,

feel or act)

APO-SERTRALINE TABLETS

Monoamine Oxidase Inhibitors

(MAOIs), used to treat depression

(phenelzine, tranylcypromine,

moclobemide), Parkinson's

Disease (selegiline) or infections

(linezolid).

Do not take sertraline until 14

days after stopping any MAOI,

and do not take MAOIs until 14

days after stopping sertraline.

Taking sertraline with MAOIs

may cause a serious reaction with

signs such as a sudden increase in

body temperature, very high

blood pressure, rigid muscles,

nausea/vomiting and/or fits

(convulsions). Your doctor will

know when it is safe to start

sertraline after the MAOI has

been stopped.

You have had an allergic

reaction to sertraline or any of

the ingredients listed at the end

of this leaflet.

Symptoms of an allergic reaction

may include cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body, rash, itching or hives

on the skin; fainting or hayfever-

like symptoms

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed on

the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

mania, hypomania, bipolar

disorder or any other conditions

which affect the way you think,

feel or act

epilepsy or convulsions, fits or

seizures (you should avoid taking

sertraline if your epilepsy is not

properly controlled; if it is

properly controlled your doctor

will wish to watch you carefully

if you take sertraline)

heart problems

liver problems

kidney problems

problems with blood clotting or

abnormal bleeding

thoughts or actions relating to

self-harm or suicide.

You are currently pregnant or you

plan to become pregnant. It is not

recommended that you take this

medicine whilst pregnant.

The effects of sertraline on the

developing baby are not yet

known. There have been reports

that babies exposed to sertraline

and other antidepressants during

the third trimester of pregnancy

may develop complications after

birth. Do not take this medicine

whilst pregnant until you and

your doctor have discussed the

risks and benefits involved.

You are currently breast-feeding

or you plan to breast-feed.

Sertraline passes into breast milk

and may affect your baby.

Do not take this medicine whilst

breast-feeding until you and your

doctor have discussed the risks

and benefits involved.

You are planning to have, or have

recently had, surgery or an

anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some combinations of medicines

may increase the risk of serious

side effects and are potentially life-

threatening. Therefore some

medicines must not be taken with

sertraline. These include:

monoamine oxidase inhibitors,

such as moclobemide, phenelzine,

tranylcypromine, selegiline and

linezolid

pimozide

Some other medicines may interact

with sertraline. These include:

phentermine, a weight loss

medicine

tryptophan, contained in some

multivitamin and herbal

preparations

tramadol, a strong pain-killer

sumatriptan, naratriptan and

zolmitriptan, used for treating

migraines

St John's Wort (Hypericum

perforatum ) , a herbal remedy for

mood disorders

other SSRIs (e.g. fluoxetine,

citalopram, paroxetine,

fluvoxamine)

other medicines for depression,

mood disorders or social anxiety

disorder, such as dothiepin,

desipramine, amitriptyline,

lithium and venlafaxine

medicines called antipsychotics,

used to treat psychoses,

schizophrenia and other

conditions which affect the way

you think, feel or act

prochlorperazine, used to prevent

or treat severe nausea and

vomiting

phenytoin, used to control

epilepsy or fits

medicines used to treat heart

conditions, such as flecainide and

propafenone

medicines called diuretics, used

to get rid of excess fluid from the

APO-SERTRALINE TABLETS

body, and to treat high blood

pressure

medicines known to prolong

bleeding, e.g. aspirin, other non-

steroidal anti-inflammatory drugs

(NSAIDs) and anti-coagulants

(such as warfarin), which can thin

the blood

cimetidine, used to treat stomach

ulcers or reflux

methadone, a medicine used to

treat drug addiction

diazepam, a medicine used to

treat anxiety disorders

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with sertraline.

How to take this

medicine

Follow carefully all directions given

to you by your doctor or pharmacist.

Their instructions may be different to

the information in this leaflet.

How much to take

Your doctor or pharmacist will tell

you how much of this medicine you

should take. This will depend on

your condition and whether you are

taking any other medicines.

Adults (18 years and older)

For Depression

The usual starting dose for sertraline

is one 50 mg tablet each day. The

dose can be increased gradually up to

200 mg a day if necessary.

For Social Phobia (Social Anxiety

Disorder)

The usual starting dose for sertraline

is 25 mg per day (half a 50 mg

tablet), increasing to 50 mg per day

after one week.

The maximum recommended dose of

sertraline for the treatment of social

phobia is 200 mg per day.

For Pre-Menstrual Dysphoric

Disorder (PMDD)

The usual starting dose for sertraline

is one 50 mg tablet each day, either

throughout the menstrual cycle (to a

maximum of 150 mg daily) or for the

last 14 days before the start of your

period (to a maximum of 100 mg

daily).

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

Swallow the tablets with a glass of

water.

When to take it

Take your tablets once a day, either

in the morning or in the evening.

Take this medicine at the same time

each day. Taking it at the same time

each day will have the best effect and

will also help you remember when to

take it.

It does not matter if you take it

before, with or after food.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

Most antidepressants take time to

work, so don't be discouraged if you

don't feel better right away. Some of

your symptoms may improve in 1 or

2 weeks but it can take up to 4 to 6

weeks to feel any real improvement.

Even when you feel well, you will

usually have to take sertraline for

several months or even longer to

make sure the benefits will last.

Make sure you have enough to last

over weekends and holidays.

Occasionally the symptoms of

depression or other psychiatric

conditions may include thoughts of

harming yourself or committing

suicide. It is possible that these

symptoms may continue or increase

until the full anti-depressant effect of

your medicine becomes apparent (i.e.

one to two months).

You or anyone close to you or

caring for you should watch for

these symptoms and tell your

doctor immediately or go to the

nearest hospital if you have any

distressing thoughts or experiences

during this initial period or at any

other time.

Also contact your doctor if you

experience any worsening of your

depression or other symptoms at any

time during your treatment.

Stopping Treatment

Do not stop taking this medicine

even if you begin to feel better.

Your doctor may decide that you

should continue to take it for some

time, even when you have overcome

your problem. For best effect, this

medicine must be taken regularly.

Your doctor will tell you when and

how this medicine should be

discontinued. Your doctor will

usually recommend that you stop

treatment by slowly reducing the

dosage over a period of several

weeks. When you stop treatment with

this medicine especially if this is

done suddenly, you may experience

unwanted side effects such as

headache, feeling dizzy, sick,

irritable, agitated, lethargic or

anxious; sweating; pins and needles

or electric shock feelings, changing

moods or emotions, or disturbed

sleep if sertraline is stopped,

particularly if stopped suddenly.

If you forget to take it

Do not take an extra dose. Wait until

the next day and take your normal

dose then.

Do not take a double dose to make

up for missed doses.

This may increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

APO-SERTRALINE TABLETS

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively go to the Accident

and Emergency Department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

If you take too much sertraline, you

may have some of the following

symptoms: sedation, nausea,

diarrhoea, vomiting, fast heartbeat,

tremor, agitation, dizziness and

unconsciousness.

While you are taking

this medicine

Things you must do

People taking sertraline may be

more likely to think about killing

themselves or actually try to do so,

especially when sertraline is first

started or the dose is changed. Tell

your doctor immediately if you

have thoughts about killing

yourself or if you are close to or

care for someone using sertraline

who talks about or shows signs of

killing him or herself.

All mentions of suicide or violence

must be taken seriously.

Occasionally, the symptoms of

depression may include thoughts of

suicide or self-harm. It is possible

that these symptoms continue or get

worse during the first one to two

months of taking sertraline until the

medicine starts to work completely.

This is more likely to occur if you are

a young adult, i.e. 18 to 24 years of

age, and you have not used

antidepressant medicines before.

If you or someone you know or

care for demonstrates any of the

following warning signs of suicide-

related behaviour while taking

sertraline, contact a doctor

immediately, or even go to the

nearest hospital for treatment:

thoughts or talk of death or

suicide

thoughts of talk of self-harm or

harm to others

any recent attempts of suicide or

self-harm

increase in aggressive behaviour,

irritability or agitation

worsening of depression.

Tell your doctor immediately if you

become pregnant.

If you are a woman of child-

bearing age, you should avoid

becoming pregnant while taking

sertraline.

Make sure your midwife and/or

doctor know you are taking

sertraline. When taken during

pregnancy, particularly in the last 3

months of pregnancy, medicines like

sertraline may increase the risk of a

serious condition in babies, called

persistent pulmonary hypertension of

the newborn (PPHN), making the

baby breathe faster and appear

bluish. These symptoms usually

begin during the first 24 hours after

the baby is born. If this happens to

your baby you should contact your

midwife and/or doctor immediately.

Some people (especially older people

or those taking diuretics/water

tablets) may experience a lack of

sodium in the blood when taking this

medicine. Tell your doctor if you get

a headache or start to feel dizzy,

confused, forgetful, weak, unsteady

or unable to concentrate.

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are breast-feeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Tell your doctor if, for any reason,

you have not taken your medicine

exactly as prescribed.

Otherwise, your doctor may think

that it was not effective and change

your treatment unnecessarily.

Tell your doctor if you feel the

tablets are not helping your

condition.

If you are being treated for

depression, be sure to discuss with

your doctor any problems you may

have and how you feel, especially

any feelings of severe sadness,

thoughts of suicide, bursts of unusual

energy, anger or aggression, or if you

become particularly agitated or

restless.

Tell your doctor immediately if

you have any suicidal thoughts or

other mental/mood changes.

Make sure you have enough tablets

to last over weekends and holidays.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours

Take your medicine to treat any

other condition unless your

doctor or pharmacist tells you to

Stop taking your medicine, or

change the dosage, without first

checking with your doctor. If you

stop taking it suddenly, your

condition may worsen or you may

have unwanted side effects (see

"Things to be careful of").

Things to be careful of

Be careful when driving or operating

machinery until you know how this

medicine affects you.

APO-SERTRALINE TABLETS

This medicine may cause dizziness,

drowsiness or impaired concentration

in some people. If you have any of

these symptoms, do not drive,

operate machinery, or do anything

else that could be dangerous.

Be careful when drinking alcohol

while you are taking sertraline.

If you drink alcohol, dizziness,

drowsiness or impaired concentration

may be worse.

Although drinking moderate amounts

of alcohol is unlikely to affect your

response to this medicine, your

doctor may suggest avoiding alcohol

while you are being treated with this

medicine.

You should wait at least 14 days after

stopping sertraline before starting

any medicines known as monoamine

oxidase inhibitors (MAOIs), such as

selegiline, phenelzine,

tranylcypromine, moclobemide and

linezolid.

The effects of sertraline may last for

some days after you have stopped

taking it.

When your doctor decides that you

should stop taking this medicine, the

dose may be reduced slowly or the

time between the doses increased

over 1 to 2 weeks.

Some people may have symptoms

such as such as headache, feeling

dizzy, sick, irritable, agitated,

lethargic or anxious; sweating; pins

and needles or electric shock

feelings, changing moods or

emotions, or disturbed sleep if

sertraline is stopped, particularly if

stopped suddenly.

Possible side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking sertraline

or if you have any questions or

concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you.

This list includes the more common

side effects. Mostly, these are mild:

feeling tired and weak (fatigued),

hot flushes, fever, feeling unwell,

shaking or tremors, headache,

dizziness

muscle pain, stiffness, weakness

or cramps, decrease or loss of

touch or other senses

dry mouth, increased sweating,

feeling or being sick, diarrhoea or

loose bowel motions,

constipation, indigestion, stomach

pain

tiredness, sleepiness, sleeping

difficulties

weight increase or decrease

sexual problems, painful erection

frightening dreams, yawning,

teeth grinding, increased or

decreased appetite, impaired

concentration

excessive and/or abnormal

movements

increased muscle tension, muscle

twitching

vision disturbance, dilated pupils

or eye pain

menstrual irregularities, unusual

vaginal bleeding

loss of bladder control

unusual hair loss or thinning

tingling or numbness of the hands

or feet

breast enlargement in men or the

unusual secretion of breast milk

in men or women

increased sensitivity of the skin to

mild rash, itchy skin

ringing or other persistent noise

in the ears

migraine

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects.

You may need medical attention.

Most of these side effects are rare.

agitation, nervousness, anxiety,

worsening of depression

abnormal or suspicious thinking

general swelling or swollen

hands, ankles, feet or face or eye

area due to fluid build-up

severe stomach or abdominal pain

symptoms of hyperglycaemia

(high blood sugar): feeling

hungry, thirsty and/or frequent or

excessive urination

agitation, anxiety, dizziness,

feeling tense and restless, tired,

drowsy, lack of energy, irritable,

problems sleeping, headache,

nausea and tingling or numbness

of the hands and feet after

stopping sertraline.

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious side effects

and are usually very rare. You may

need urgent medical attention or

hospitalisation.

Convulsions (fits or seizures)

coma (unconsciousness)

a collection of symptoms

including weight gain (despite

loss of appetite), feeling and

being sick, muscle weakness and

irritability

severe rash, with blisters and/ or

excessive peeling of skin

skin rash combined with inflamed

blood vessels

a sudden increase in body

temperature, very high blood

pressure, rigid muscles, nausea/

vomiting and/or fits

(convulsions). These symptoms

may be signs of a rare condition

called Serotonin Syndrome.

APO-SERTRALINE TABLETS

Neuroleptic Malignant Syndrome

(a serious reaction to some

medicines with a sudden increase

in body temperature, extremely

high blood pressure and severe

convulsions)

fast, slow or irregular heartbeat,

high blood pressure

palpitations, fainting or chest pain

abnormal bleeding

difficulty in passing urine or

blood in the urine

severe blisters and bleeding in the

lips, eyes, mouth, nose and

genitals

fever, sore throat, swollen glands,

mouth ulcers, unusual bleeding or

bruising under the skin

mood of excitement, over-activity

and uninhibited behaviour or

aggression

hearing, seeing or feeling things

that are not there (hallucinations)

thoughts of suicide or attempting

suicide or self-harm

breathing problems

jaundice (yellowing of the skin

and/or eyes) , with or without

other signs of hepatitis or liver

failure (loss of appetite, tiredness,

feeling or being sick, dark urine,

stomach pain or swelling,

confusion, unconsciousness).

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to sertraline, do

not take any more of this medicine

and tell your doctor immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing.

swelling of the face, lips, tongue,

or other parts of the body

rash, itching or hives on the skin

fainting

hayfever-like symptoms

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 25°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep this medicine where children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor or pharmacist tells you

to stop taking this medicine or they

have passed their expiry date, your

pharmacist can dispose of the

remaining medicine safely.

Product description

What APO-Sertraline looks

like

50 mg tablets:

White to off white, capsule shaped,

biconvex, film coated tablets with

breakline on one side and '50' and

'BL' embossed on either side of the

breakline.

100 mg tablets:

White to off white, capsule shaped,

biconvex, film coated tablets with

'100' and 'BL' embossed on one side.

* Not all strengths, pack types and/or

pack sizes may be available.

Ingredients

Each tablet contains 50 mg or 100

mg of sertraline as the active

ingredient.

It also contains the following inactive

ingredients:

Calcium hydrogen phosphate

anhydrous

cellulose - microcrystalline

hyprolose

Sodium starch glycollate type A

Magnesium stearate

Hypromellose

Titanium dioxide

Macrogol 400

Polysorbate 80

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

APO-Sertraline 50 mg tablets:

PVC/Al Blister packs of 30

AUST R 213177.

APO-Sertraline 100 mg tablets:

PVC/Al Blister packs of 30

AUST R 213180.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in:

January 2017

APO-SERTRALINE TABLETS

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First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

16-5-2018

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.

FDA - U.S. Food and Drug Administration

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

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