Pharm-Olanzapine

Main information

  • Trade name:
  • Pharm-Olanzapine olanzapine 5mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pharm-Olanzapine olanzapine 5mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207860
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207860

Pharm-Olanzapine olanzapine 5mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Pharmacor Pty Ltd

Postal Address

Suite 501,7 Oaks Ave,Dee Why, NSW, 2099

Australia

ARTG Start Date

12/12/2014

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. Pharm-Olanzapine olanzapine 5mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

9/03/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Olanzapine is indicated for the treatment of schizophrenia and related psychoses.,Olanzapine alone or in combination with lithium or valproate is

indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.,Olanzapine is indicated for preventing recurrence of

manic, mixed or depressive episodes in Bipolar I Disorder.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

28's blister pack (2 x 14 or 4x7's tablets)

(S4) Prescription Only Medicine

7's (1 x 7 tablets)

(S4) Prescription Only Medicine

Components

1. Pharm-Olanzapine olanzapine 5mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off white colored, film coated, round shaped, biconvex tablets,

imprinted '5' with black ink on one side and plain on the other side.

Active Ingredients

Olanzapine

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 27.11.2017 at 11:52:22 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

Pharm-Olanzapine

PHARM-OLANZAPINE

olanzapine

Consumer Medicine Information

What is in this leaflet

This

leaflet

designed

provide

you with answers to some common

questions about this medicine. It does

contain

available

information

does

take

place of talking with your doctor.

The information in this leaflet was

last updated on the date shown on the

final page. More recent information

about this medicine may be available.

Make

sure

speak

your

pharmacist

doctor

obtain

most up to date information on this

medicine.

All medicines have risks and

benefits.

Your

doctor

more

information

about this medicine than is contained

in this leaflet. Also, your doctor has

had the benefit of taking a full and

detailed history from you and is in

the best position to make an expert

judgement to meet your individual

needs.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with this

medicine.

You may need to read it again.

What Pharm-

Olanzapine is used for

Pharm-Olanzapine

belongs

group

medicines

called

antipsychotics.

helps

correct

chemical

imbalances

brain,

which may cause mental illness.

Pharm-Olanzapine

used

treat

symptoms

schizophrenia

related psychoses. Schizophrenia is a

mental

illness

with

disturbances

thinking, feelings and behaviour.

Pharm-Olanzapine

alone,

combination

with

lithium

valproate, is used for the short-term

treatment

acute

manic

episodes

associated with Bipolar I Disorder.

Pharm-Olanzapine

also

mood

stabiliser

that

prevents

further

occurrences

disabling

high

(depressed)

extremes

mood

associated

with

Bipolar

Disorder.

Bipolar I Disorder is a mental illness

with

symptoms

such

feeling

"high", having excessive amounts of

energy, needing much less sleep than

usual,

talking

very

quickly

with

racing

ideas

sometimes

severe

irritability.

Your doctor may have prescribed

Pharm-Olanzapine

another

reason.

Ask your doctor if you have any

questions

about

why

Pharm-

Olanzapine has been prescribed

for you.

This medicine is available only with

a doctor's prescription.

Pharm-Olanzapine

recommended

children

under the age of 18 years as there is

enough

information

effects in this age group.

Before taking

Pharm-Olanzapine

Tell your doctor if you have any of

the following conditions or if you

have ever experienced any of these

conditions.

When you must not take it

Do not take Pharm-Olanzapine:

if

you

have

had

an

allergic

reaction to any type of Pharm-

Olanzapine or to any of the

ingredients listed at the end of

this

leaflet

(see

'Product

Description').

Signs of an allergic reaction may

include

skin

rash,

itching,

shortness of breath or swelling of

the face, lips or tongue.

if the packaging is torn or

shows signs of tampering or the

tablets

or

wafers

do

not

look

quite right.

if the expiry date on the pack

has passed.

If you take this medicine after the

expiry date has passed it may not

work as well.

If you are not sure whether you

should

start

taking

Pharm-

Olanzapine, talk to your doctor or

pharmacist.

Before you start to take it

Tell your doctor if you have had an

allergic

reaction

to

any

medicine

which you have taken previously to

treat your current condition.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

Pharm-Olanzapine

tumour of the pituitary gland (a

small gland at the base of the

brain)

disease

blood

with

reduced number of white or red

blood cells

disease of the blood vessels of the

brain, including stroke

prostate problems

kidney or liver disease

high blood sugar, diabetes or a

family history of diabetes

breast cancer or a family history

of breast cancer

paralytic ileus, a condition where

the small bowel does not work

properly

epilepsy (seizures or fits)

glaucoma, a condition in which

there is usually a build up of fluid

in the eye

heart disease, including irregular

heart rhythm

neuroleptic malignant syndrome,

a reaction to some medicines with

sudden

increase

body

temperature, extremely high

blood pressure and severe

convulsions

tardive dyskinesia, a reaction to

some

medicines

with

uncontrollable

twitching

jerking movements of the arms

and legs.

Tell your doctor if you are pregnant

or intend to become pregnant.

Like

most

antipsychotic

medicines,

Pharm-Olanzapine is not recommended

for use during pregnancy. If there is a

need

consider

Pharm-Olanzapine

during your pregnancy, your doctor will

discuss with you the benefits and risks

of using it.

Tell your doctor if you are breast-

feeding or plan to breast-feed.

It is recommended that you do not

breast-feed

while

taking

Pharm-

Olanzapine.

Tell your doctor if you suffer from

lactose

intolerance

(because

Pharm-Olanzapine tablets contain

lactose).

Tell your doctor if you will be in a

hot

environment

or

do

a

lot

of

vigorous exercise.

Pharm-Olanzapine

make

sweat

less,

causing

your

body

overheat.

Tell your doctor if you smoke.

Smoking

affect

Pharm-

Olanzapine or may affect how it

works.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines may be affected by

Pharm-Olanzapine

affect

how it works. These include:

medicines used to treat a fast or

irregular heart beat (arrhythmia)

medicines taken for anxiety or to

help you sleep

medicines taken for depression

carbamazepine, a medicine used

for mood stabilisation and to treat

epilepsy

other centrally acting medicines

(eg. tranquillisers)

ciprofloxacin, a medicine used to

treat bacterial infections

medicines that lower blood

pressure

medicines used for Parkinson's

disease

medicines

that

change

heart's electrical activity or make

it more likely to change.

Your doctor or pharmacist has more

information

medicines

careful with or avoid while taking

Pharm-Olanzapine.

Tell your doctor about these things

before

you

take

Pharm-

Olanzapine.

How to take Pharm-

Olanzapine

Follow all directions given to you

by

your

doctor

or

pharmacist

carefully.

These

differ

from

information

contained

this

leaflet.

How much to take

Pharm-Olanzapine tablets:

Your doctor will tell you how many

Pharm-Olanzapine

tablets

should take. The dose your doctor

will prescribe for you will usually

be in the range 5 mg to 20 mg per

day.

Your

doctor

increase

decrease your dose in order to find

appropriate

dose

your

condition.

lower

starting

dose

prescribed for elderly patients over

the age of 65 years.

How to take it

Pharm-Olanzapine

tablets

should

be swallowed whole with a glass

of water.

When to take it

Pharm-Olanzapine

tablets

should be taken once a day as

advised by your doctor.

Take your prescribed dose at the

same time each day.

Pharm-Olanzapine

tablets

taken with or without food.

How long do I take it

Do

not

stop

taking

Pharm-

Olanzapine just because you feel

better. It is important that you

do

NOT

stop

taking

Pharm-

Olanzapine

unless

your

doctor

tells you.

If you forget to take it

If it is almost time for your next

dose skip the dose you missed and

take your next dose when you are

meant to.

Pharm-Olanzapine

Otherwise,

take

soon

remember then go back to taking your

medicine as you would normally.

Do not take a double dose to make

up for the dose that you missed.

If you are not sure what to do, ask

your doctor or pharmacist.

If you take too much

Immediately telephone your doctor

or

the

Australian

Poisons

Information Centre (telephone 13

11 26) or the New Zealand

National Poisons Centre (0800

POISON or 0800 764 766), or go to

Accident and Emergency at your

nearest hospital, if you think that

you or anyone else has taken too

much Pharm-Olanzapine. Do this

even

if

there

are

no

signs

of

discomfort or poisoning.

If you have taken too much Pharm-

Olanzapine,

most

common

signs are fast heart beat, agitation/

aggression,

difficulty

speaking,

uncontrollable

movements

sedation.

While you are taking

Pharm-Olanzapine

Things you must do

It is important that you remember

to

take

Pharm-Olanzapine

daily

and at the dose prescribed by your

doctor.

Tell

all

doctors,

dentists

and

pharmacists who are treating you

that

you

are

taking

Pharm-

Olanzapine.

While

you

are

taking

Pharm-

Olanzapine,

tell

your

doctor

or

pharmacist before you start any

new medicine.

If

you

become

pregnant

while

taking

Pharm-Olanzapine,

tell

your doctor.

Keep

all

of

your

doctor's

appointments

so

that

your

progress can be checked.

• Your doctor should monitor your

weight while you are taking

Pharm-Olanzapine.

Patients

with

diabetes

have

higher

chance

developing diabetes should have

their blood sugar checked often.

If you are over 65, your doctor

measure

your

blood

pressure from time to time.

Tell your doctor if you are female

and

your

monthly

periods

are

absent for six months or more.

Talk

to

your

doctor

or

mental

health

professional

if

you

have

thoughts or talk about death or

suicide; or thoughts or talk about

self-harm

or

doing

harm

to

others.

These may be signs of changes or

worsening in your mental illness.

Things you must not do

Do

not

stop

taking

Pharm-

Olanzapine, or lower the dosage,

even

if

you

are

feeling

better,

without

checking

with

your

doctor.

Do not give Pharm-Olanzapine to

anyone

else,

even

if

their

symptoms

seem

similar

or

they

have the same condition as you.

Your doctor has prescribed Pharm-

Olanzapine

your

condition.

Things to be careful of

Be

careful

driving

or

operating

machinery

until

you

know

how

Pharm-Olanzapine affects you.

Pharm-Olanzapine

cause

drowsiness in some people.

Be careful when drinking alcohol

while taking Pharm-Olanzapine.

The effects of alcohol could be made

worse

while

taking

Pharm-

Olanzapine.

Your doctor may suggest you avoid

alcohol while you are being treated

with Pharm-Olanzapine.

If

Pharm-Olanzapine

makes

you

feel light- headed, dizzy or faint, be

careful

when

getting

up

from

a

sitting or lying position.

Getting up slowly may help.

If

outdoors,

wear

protective

clothing

and

use

at

least

a

30+

sunscreen.

Pharm-Olanzapine may cause your

skin to be much more sensitive to

sunlight than it is normally.

Exposure to sunlight may cause a

skin rash, itching, redness, or severe

sunburn.

If

your

skin

does

appear

to

be

burning, tell your doctor.

Make sure you keep cool in hot

weather and keep warm in cool

weather.

Pharm-Olanzapine

affect

way your body reacts to temperature

changes

Side effects

medicines

have

some

unwanted

side

effects.

Sometimes

they are serious, but most of the time

they

not.

Your

doctor

weighed

risks

using

this

medicine against

the benefits they

expect it will have for you.

Like

other

medicines,

Pharm-

Olanzapine

cause

some

unwanted

side

effects.

These

likely to vary from patient to patient.

Some side effects may be related to

dose

Pharm-Olanzapine.

Accordingly, it is important that you

tell your doctor as soon as possible

about

unwanted

effects.

Your

doctor may then decide to adjust the

dose of Pharm-Olanzapine you are

taking.

Tell your doctor if you notice any

of the following side effects and

they worry you:

drowsiness

unusual tiredness or weakness

fever

restlessness or difficulty sitting

still

increased appetite, weight gain

constipation, bloating

dry mouth

swelling of your hands, feet and

ankles

Pharm-Olanzapine

aching joints

nose bleeds

dizziness, confusion, forgetfulness

Some people may feel dizzy in the

early stages of treatment, especially

when

getting

from

lying

sitting

position.

This

side

effect

usually passes after taking Pharm-

Olanzapine for a few days.

Tell your doctor if you notice any

of the above side effects and they

worry you.

These

more

common

side

effects of Pharm-Olanzapine.

Tell

your

doctor

as

soon

as

possible if you notice any of the

following side effects:

symptoms of sunburn (such as

redness,

itching,

swelling

blistering

skin)

which

occur more quickly than normal

rash or allergic reaction

• slow heart beat

• changes in sexual functioning or

sex drive in men or women

• prolonged

and/or

painful

erection

• unusual secretion of breast milk

• breast

enlargement

women

• symptoms of high sugar levels in

blood

(including

passing

large

amounts

urine,

excessive

thirst,

having

mouth and skin and weakness).

These may indicate the onset or

worsening of diabetes

• reaction

following

abrupt

discontinuation

(profuse

sweating, nausea or vomiting)

• absence of menstrual periods and

changes

regularity

menstrual periods

• involuntary passing of urine or

difficulty in initiating urination

• unusual hair loss or thinning.

These

side

effects

uncommon

but may require medical attention.

Tell your doctor immediately or

go to Accident and Emergency at

your nearest hospital if you notice

any of the following:

Sudden

signs

allergic

reaction

such

skin

rash,

itching,

shortness

breath

swelling

face,

lips

tongue.

frequent infections such as fever,

severe

chills,

sore

throat

mouth ulcers

bleeding or bruising more easily

than normal

seizures, fits or convulsions

yellowing

skin

and/or

eyes

nausea,

vomiting,

loss

appetite,

generally

feeling

unwell, fever, itching, yellowing

of the skin and/or eyes

severe upper stomach pain often

with

nausea

vomiting

(inflammation of the pancreas)

worm-like

movements

tongue,

other

uncontrolled

movements

tongue,

mouth,

cheeks,

which

may progress to the arms and

legs

sudden

increase

body

temperature, sweating, fast heart

beat,

muscle

stiffness,

high

blood pressure and convulsions

sharp

chest

pain,

coughing

blood,

sudden

shortness

breath

pain/tenderness

calf

muscle area

muscle

pain,

muscle

weakness

and brown urine

heart palpitations and dizziness,

which may lead to collapse.

These are very serious side effects.

need

urgent

medical

attention or hospitalisation.

All of these side effects are very

rare.

The following additional side

effects may occur in some groups of

people taking Pharm-Olanzapine:

Elderly patients with

dementia-related psychosis

Elderly patients with dementia-

related psychosis may notice the

following side effects:

unusual manner of walking

falls

pneumonia

involuntary passing of urine.

Parkinson's disease

psychosis

Some

patients

with

Parkinson's

disease may hallucinate (see, feel or

hear

things

that

there)

develop

worsening

symptoms

Parkinson's disease.

Pharm-Olanzapine

in

combination with lithium or

valproate

Patients

with

bipolar

mania

taking

Pharm-Olanzapine

combination

with lithium or valproate may notice

the following additional side effects:

tremors

speech disorder.

Tell

your

doctor

if

you

notice

anything

unusual

or

if

you

are

concerned about any aspect of your

health,

even

if

you

think

the

problems

are

not

connected

with

this medicine and are not referred

to in this leaflet.

Also,

some

side

effects,

such

changes to liver function, cholesterol

or triglycerides can occur. These can

only be found when your doctor does

tests from time to time to check your

progress.

Do not be alarmed by this list of side

effects.

You may not experience any of them.

Other

side

effects

listed

above

may also occur in some patients.

Tell

your

doctor

if

you

notice

anything else that is making you feel

unwell.

Pharm-Olanzapine

After

taking

Pharm-

Olanzapine

Storage

Keep

your

tablets

in

the

blister

pack until it is time to take them.

Keep your tablets in a cool, dry

place where the temperature stays

below 25°C.

Do not store Pharm-Olanzapine in

the bathroom or near a sink.

Do not leave your tablets in the

car on hot days or on window sills.

Heat

dampness

destroy

some medicines.

All

medicines

should

be

kept

where

young

children

cannot

reach them.

A locked cupboard at least one and

a half metres above the ground is a

good place to store medicines.

There will be an expiry date (month,

year)

your

Pharm-Olanzapine

container.

The medicine should not be taken

after this date because it may have

lost some of its strength.

Disposal

your

doctor

tells

stop

taking

Pharm-Olanzapine

find that the tablets have passed their

expiry date, please return any left

over tablets to your pharmacist.

Product Description

What it looks like

Pharm-Olanzapine

tablets

White to off white colored, film

coated, round shaped, biconvex

tablets, imprinted “2.5” with black

ink on one side and plain on the

other side.

Pharm-Olanzapine

tablets

White to off white colored, film

coated, round shaped, biconvex

tablets, imprinted “5” with black ink

on one side and plain on the other

side

Pharm-Olanzapine tablets 7.5 mg:

White to off white colored, film

coated,

round

shaped,

biconvex

tablets, imprinted “7.5” with black

ink on one side and plain on the

other side.

Pharm-Olanzapine tablets 10 mg:

White to off white colored, film

coated,

round

shaped,

biconvex

tablets, imprinted “10” with black

ink on one side and plain on the

other side.

Pharm-Olanzapine tablets come in

blister packs in the following pack

sizes:

Pharm-Olanzapine

tablets– 28 tablets;

Pharm-Olanzapine

tablets–

tablets

tablets;

Pharm-Olanzapine

tablets– 28 tablets;

Pharm-Olanzapine

tablets–

tablets

tablets;

Ingredients

Pharm-Olanzapine

tablets:

Active Ingredient:

tablet

olanzapine per tablet

5 mg tablet - 5 mg

olanzapine per tablet

tablet

olanzapine per tablet

tablet

olanzapine per tablet

Inactive Ingredient:

lactose, hydroxypropylcellulose,

mannitol, magnesium stearate,

pectin, glycerol triacetate, titanium

dioxide, talc-purified, isopropyl

alcohol and Opacode S-1-17823

black (ARTG # 12108).

Supplier

PHARMACOR PTY LIMITED

Suite 401, 7 Oaks Avenue

Dee Why NSW 2099

Australia

Australian Registration

Numbers

Pharm-Olanzapine tablets:

2.5 mg tablet - AUST R 207844

5 mg tablet - AUST R 207860

7.5 mg tablet - AUST R 207845

10 mg tablet - AUST R 207848

This leaflet was prepared in December

2014.

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Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

4-9-2018

Safer prescription of blood thinning agents

Safer prescription of blood thinning agents

A collaboration between pharmaceutical companies, pharmacies and authorities has eliminated a common cause of dosing errors involving blood thinning agents.

Danish Medicines Agency

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

23-8-2018

August 22, 2018: Louisiana Pharmacist Convicted of Trafficking and Selling Stolen Medication

August 22, 2018: Louisiana Pharmacist Convicted of Trafficking and Selling Stolen Medication

August 22, 2018: Louisiana Pharmacist Convicted of Trafficking and Selling Stolen Medication

FDA - U.S. Food and Drug Administration

20-8-2018

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

FDA - U.S. Food and Drug Administration

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

13-7-2018

Scientific guideline:  Guideline on good pharmacogenomic practice - First version, adopted

Scientific guideline: Guideline on good pharmacogenomic practice - First version, adopted

This guideline provides recommendations for the conduct of genomic studies in relation to medical therapy in order to provide high quality information on the impact of genomic variability on drug response. Primary focus is on the analysis of genomic germline DNA. The analysis of somatic DNA and genomic biomarkers for cancer treatment is not being discussed and might be developed as an Annex or in separate guidance.

Europe - EFSA - European Food Safety Authority EFSA Journal

11-7-2018

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

FDA - U.S. Food and Drug Administration

11-7-2018

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

FDA - U.S. Food and Drug Administration

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

1-6-2018

Demulen 30 birth control pills: Packages containing broken or chipped pills

Demulen 30 birth control pills: Packages containing broken or chipped pills

Pfizer Canada Inc. has notified Health Canada that it has received complaints of broken or chipped pills involving Demulen 30, a prescription birth control pill. Health Canada has previously communicated on similar issues involving two other brands of birth control pills. Health Canada continues to remind women to check their packages of birth control pills and to report problems if they see them. If you notice anything unusual in the package, such as missing or damaged pills, you should return the packa...

Health Canada

11-5-2018

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present

The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.

FDA - U.S. Food and Drug Administration

10-5-2018

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

FDA - U.S. Food and Drug Administration

17-4-2018

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

FDA - U.S. Food and Drug Administration

16-4-2018

Women taking birth control pills reminded to return any packages for replacement if the pills are missing or look unusual

Women taking birth control pills reminded to return any packages for replacement if the pills are missing or look unusual

In light of continuing complaints of quality issues involving certain prescription birth control pills, Health Canada is reminding women to check their packages of birth control pills. If you notice anything unusual in the package, such as missing or damaged pills, you should return the package to the pharmacy for replacement as soon as possible. Skipping a dose because the pill is missing, or taking a damaged (for example, chipped or fragmented) pill, may increase the risk of pregnancy because less acti...

Health Canada

28-3-2018

DKMA Update March 2018

DKMA Update March 2018

In this issue of DKMA Update you can read about evidence; changes to Tramadol’s summary of product characteristics; inspections of the sale of OTC medicines outside pharmacies and much more

Danish Medicines Agency

25-1-2018

How to Buy Medicines Safely From an Online Pharmacy

How to Buy Medicines Safely From an Online Pharmacy

How can you tell if an online pharmacy is operating legally? The FDA's BeSafeRx web page can help you identify and avoid rogue online pharmacies. The FDA has tips for buying medicines online safely.

FDA - U.S. Food and Drug Administration

3-11-2017

New Director of Division for Pharmacovigilance & Medical Devices

New Director of Division for Pharmacovigilance & Medical Devices

Jens Piero Quartarolo has been appointed new Director of Division for Pharmacovigilance & Medical Devices and will form part of the Danish Medicines Agency's leadership team.

Danish Medicines Agency

12-9-2017

E2B acknowledgment format change

E2B acknowledgment format change

Companies that use the Danish Medicines Agency's Pharmacovigilance System should be aware that we have changed the MessageFormatRelease value from 2.0 to 1.0.

Danish Medicines Agency

11-9-2017

DKMA Update

DKMA Update

Our newsletter Danish Pharmacovigilance Update changes name to DKMA Update and will from now on contain information about medicinal products in general, patient safety and life science.

Danish Medicines Agency

1-8-2017

Withdrawal of one more batch of counterfeit packs of the schizophrenia medicine Xeplion 150 mg

Withdrawal of one more batch of counterfeit packs of the schizophrenia medicine Xeplion 150 mg

German and Danish parallel importers and the Danish Medicines Agency are now withdrawing the fourth batch of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batch contains counterfeit packs.

Danish Medicines Agency

27-7-2017

Counterfeit packs of the schizophrenia medicine Xeplion 150 mg

Counterfeit packs of the schizophrenia medicine Xeplion 150 mg

One German and several Danish parallel importers and the Danish Medicines Agency have withdrawn several batches of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batches contained counterfeit packs.

Danish Medicines Agency

8-6-2017

Danish Pharmacovigilance Update, May 2017

Danish Pharmacovigilance Update, May 2017

The May issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

22-5-2017

Danish Pharmacovigilance Update, April 2017

Danish Pharmacovigilance Update, April 2017

The April issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

18-4-2017

Danish Pharmacovigilance Update, March 2017

Danish Pharmacovigilance Update, March 2017

The March issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

6-3-2017

Danish Pharmacovigilance Update, February 2017

Danish Pharmacovigilance Update, February 2017

The February issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

3-2-2017

Danish Pharmacovigilance Update, January 2017

Danish Pharmacovigilance Update, January 2017

The January issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

6-1-2017

Danish Pharmacovigilance Update, December 2016

Danish Pharmacovigilance Update, December 2016

The December issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

20-12-2016

New chair of PhVWP-V

New chair of PhVWP-V

Lisbet Vesterager Borge, veterinarian, has been elected chair of the European Pharmacovigilance Working Party Veterinary (PhVWP-V).

Danish Medicines Agency

9-12-2016

Danish Pharmacovigilance Update, November 2016

Danish Pharmacovigilance Update, November 2016

The November issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

15-11-2016

Danish Pharmacovigilance Update, October 2016

Danish Pharmacovigilance Update, October 2016

The October issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

3-11-2016

Danish Pharmacovigilance Update, September 2016

Danish Pharmacovigilance Update, September 2016

The September issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

7-10-2016

Experts for the European Pharmacopoeia's groups of experts and working parties

Experts for the European Pharmacopoeia's groups of experts and working parties

A very large part of the work related to the drafting of new monographs for the European Pharmacopoeia (EDQM) is carried out by external experts in 75 groups of experts and working parties. Experts for the groups are appointed for a period of three years, and the EDQM is now seeking experts for the period from 2017 to 2019.

Danish Medicines Agency

13-9-2016

Danish Pharmacovigilance Update, August 2016

Danish Pharmacovigilance Update, August 2016

The August issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

5-7-2016

Danish Pharmacovigilance Update, June 2016

Danish Pharmacovigilance Update, June 2016

The June issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

3-6-2016

Danish Pharmacovigilance Update, May 2016

Danish Pharmacovigilance Update, May 2016

The May issue of Danish Pharmacovigilance Update with news from the EU.

Danish Medicines Agency

10-5-2016

Danish Pharmacovigilance Update, April 2016

Danish Pharmacovigilance Update, April 2016

The April issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.

Danish Medicines Agency

29-4-2016

Two new directors to join the Danish Medicines Agency

Two new directors to join the Danish Medicines Agency

The Danish Medicines Agency has appointed Janne Lehmann Knudsen as Director of Pharmacovigilance & Medical Devices and Iben Vitved as Director of Finance.

Danish Medicines Agency

25-4-2016

Danish Pharmacovigilance Update, March 2016

Danish Pharmacovigilance Update, March 2016

The March issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.

Danish Medicines Agency

9-3-2016

Danish Pharmacovigilance Update, February 2016

Danish Pharmacovigilance Update, February 2016

The February issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.

Danish Medicines Agency

10-2-2016

Danish Pharmacovigilance Update, January 2016

Danish Pharmacovigilance Update, January 2016

The January issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.

Danish Medicines Agency

8-1-2016

Danish Pharmacovigilance Update, December 2015

Danish Pharmacovigilance Update, December 2015

The December issue of Danish Pharmacovigilance Update with news from the EU, the Danish Medicines Agency and short news.

Danish Medicines Agency

4-1-2016

The Danish Medicines Agency has a new website

The Danish Medicines Agency has a new website

Today, the Danish Medicines Agency launched its new website – laegemiddelstyrelsen.dk/en – where you can read about and subscribe to news about licensing and supervision of medicines, side effects, reimbursement, pharmacies and medical devices.

Danish Medicines Agency

8-12-2015

Danish Pharmacovigilance Update, November 2015

Danish Pharmacovigilance Update, November 2015

The November issue of Danish Pharmacovigilance Update with news from the EU, the Danish Medicines Agency and short news.

Danish Medicines Agency

12-11-2015

Danish Pharmacovigilance Update, October 2015

Danish Pharmacovigilance Update, October 2015

The October issue of Danish Pharmacovigilance Update with news from the EU, the Danish Medicines Agency and short news.

Danish Medicines Agency

7-10-2015

Danish Pharmacovigilance Update, September 2015

Danish Pharmacovigilance Update, September 2015

The September issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.

Danish Medicines Agency

19-9-2018

Agenda:  Agenda – 12th Pharmacovigilance stakeholder forum

Agenda: Agenda – 12th Pharmacovigilance stakeholder forum

Europe - EMA - European Medicines Agency

19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

30-8-2018

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'. Closing date 31 October 2018

Therapeutic Goods Administration - Australia

30-8-2018

Modified release paracetamol

Modified release paracetamol

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'

Therapeutic Goods Administration - Australia

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1991 (TurnKey PharmaConsulting Ireland Limited)

EU/3/18/1991 (TurnKey PharmaConsulting Ireland Limited)

EU/3/18/1991 (Active substance: Docosahexaenoic acid ethyl ester) - Orphan designation - Commission Decision (2018)1880 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/235/17

Europe -DG Health and Food Safety