TARGIN

Main information

  • Trade name:
  • TARGIN oxycodone hydrochloride / naloxone hydrochloride 30/15mg modified release tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TARGIN oxycodone hydrochloride / naloxone hydrochloride 30/15mg modified release tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216280
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216280

TARGIN oxycodone hydrochloride / naloxone hydrochloride 30/15mg modified release tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Mundipharma Pty Ltd

Postal Address

GPO Box 5214,SYDNEY, NSW, 2001

Australia

ARTG Start Date

24/09/2014

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. TARGIN oxycodone hydrochloride / naloxone hydrochloride 30/15mg modified release tablets blister pack

Product Type

Single Medicine Product

Effective date

11/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

1- The management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. The naloxone component in a fixed combination with

oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,2- Second line symptomatic treatment of patients with severe to

very severe idiopathic restless legs syndrome after failure of dopaminergic therapy

The management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. The naloxone component in a fixed combination with

oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S8) Controlled Drug

(S8) Controlled Drug

(S8) Controlled Drug

Components

1. TARGIN oxycodone hydrochloride / naloxone hydrochloride anhydrous 30/15mg modified release tablets blister pack

Dosage Form

Tablet, modified release

Route of Administration

Oral

Visual Identification

Brown, capsule shaped tablet, OXN marked on one side and 30 on other.

Active Ingredients

naloxone hydrochloride dihydrate

16.48 mg

oxycodone hydrochloride

30 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 07:29:51 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

TARGIN

®

tablets

Oxycodone hydrochloride and naloxone hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about TARGIN tablets.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking this medicine

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What TARGIN tablets

are taken for

TARGIN tablets contain two

different medicines called oxycodone

hydrochloride and naloxone

hydrochloride anhydrous.

Oxycodone belongs to a group of

medicines called opioid analgesics.

Naloxone is a medicine which, when

taken orally, can block some of the

effects of opioids in the gut, such as

constipation.

Pain relief:

TARGIN tablets are used to relieve

moderate to severe persistent pain

when other forms of treatment have

not been effective. The naloxone in

TARGIN tablets will help prevent

and treat opioid-induced

constipation.

Restless legs syndrome:

TARGIN tablets are also used to

relieve the symptoms of severe to

very severe restless legs syndrome in

people who can't be treated with

dopamine medicines. People with

restless legs syndrome have

unpleasant sensations in their limbs.

This can start as soon as they sit or

lie down and is only relieved by an

irresistible urge to move the legs,

sometimes the arms and other parts

of the body. It makes sitting still and

sleeping very difficult.

TARGIN tablets helps to relieve the

unpleasant sensations and so reduces

the urge to move the limbs.

Your doctor, however, may prescribe

it for another purpose.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

As with all strong painkillers, your

body may become used to you taking

TARGIN tablets. Taking it may

result in physical dependence.

Physical dependence means that you

may experience withdrawal

symptoms if you stop taking

TARGIN tablets suddenly, so it is

important to take it exactly as

directed by your doctor.

This medicine is only available with

a doctor's prescription.

Before you take

TARGIN

Long-term use of TARGIN tablets

may affect your fertility. If you have

any concerns about taking this

medicine, ask your doctor.

When you must not take it

Do not take TARGIN tablets if

you:

have moderate or severe liver

disease

have any breathing problems such

as severe asthma, respiratory

depression (breathing slows or

weakens) or other obstructive

airways disease

are severely drowsy or have a

reduced level of consciousness

have a condition where your

stomach empties more slowly

than it should or any condition

that obstructs the stomach/bowel

or affects bowel transit

(movement of food or ingested

material along the bowel)

have sudden severe abdominal

pain

have irregular heart beats or

changes in the way the heart beats

have a head injury, brain tumour

or have raised pressure within the

head, brain or spinal cord

suffer from uncontrolled

convulsions, fits or seizures

have heart problems due to long-

term lung disease

have just consumed and/or

regularly consume large amounts

of alcohol or have confusion and

shaking due to alcohol

withdrawal

take a medicine for depression

called a 'monoamine oxidase

inhibitor' or have taken any in the

last two weeks

are about to have an operation

(including surgery on your spine

for pain relief in the next 24

TARGIN

TABLETS MFCTARGI11017 (SUPERSEDES MFCTARGI10716)

hours) or have had an operation

within the last 24 hours

have a history of opioid abuse.

Do not take TARGIN tablets if you

are allergic to oxycodone,

naloxone, opioid painkillers, or any

of the ingredients listed at the end

of this leaflet.

Some of the symptoms of an allergic

reaction may include:

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

Do not take this medicine if you

are pregnant or intend to become

pregnant whilst taking this

medicine.

Like most medicines of this kind,

TARGIN tablets are not

recommended to be taken during

pregnancy. Your doctor will discuss

the risks of taking it if you are

pregnant.

Do not breastfeed if you are taking

this medicine.

The active ingredients in TARGIN

tablets may pass into breast milk and

there is a possibility that your baby

may be affected. Your doctor can

discuss with you the risks involved.

Do not give this medicine to a child

younger than 12 years of age.

Safety and effectiveness in children

younger than 12 years of age have

not been established.

Do not take this medicine after the

expiry date (EXP) printed on the

pack.

If you take it after the expiry date has

passed, it may not work very well.

Do not take it if the packaging is torn

or shows signs of tampering.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

chronic kidney, liver or lung

disease

high or low blood pressure

problems with your heart and

blood circulation

underactive thyroid gland

disease of your gall bladder or

bile duct

inflammation of the pancreas

inflammatory bowel disease or

recent abdominal surgery

enlarged prostate

underactive adrenal glands

epileptic disorders or are prone to

having convulsions

galactose intolerance, lactose

deficiency or glucose-galactose

malabsorption

some cancers of the digestive

tract or pelvis

severe mental condition involving

losing contact with reality,

hearing voices or an ability to

think clearly

an addiction or history of abuse

of alcohol, opioids or other drugs

sleep apnoea, a condition

characterised by frequent

breathing stops during the night

which may make you feel very

sleepy during the daytime

episodes of suddenly falling

asleep or sleepiness occur.

Tell your doctor if you have used

an opioid before.

Using TARGIN tablets after using

doses of other opioids may lead to

withdrawal symptoms or diarrhoea.

If you have not told your doctor

about any of the above, tell them

before you take any TARGIN

tablets.

Taking other medicines

Tell your doctor if you are taking

any other medicines or dietary

supplements, including any that

you buy without a prescription

from your pharmacy, supermarket

or health food shop.

Some medicines, alcohol and

TARGIN tablets may interfere with

each other. These medicines include:

medicines used to treat

depression, psychiatric or mental

disorders

medicines used to treat

depression belonging to a group

called monoamine oxidase

inhibitors must be stopped 14

days before TARGIN tablets are

taken

medicines to help you sleep

other pain relievers including

other opioids

medicines used to prevent or

relieve the symptoms of allergy

medicines to stop nausea or

vomiting e.g. metoclopramide or

prochlorperazine

cimetidine, a medicine used to

treat stomach ulcers or heartburn

medicines to put you to sleep

during an operation or procedure

medicines used to thin the blood

e.g. coumarin derivatives such as

warfarin

medicines used to lower blood

pressure

quinidine and other medicines

used to treat the heart

medicines to treat convulsions

e.g. phenytoin, carbamazepine

antifungals e.g. ketoconazole

antibiotics e.g. clarithromycin,

rifampicin

medicines to treat HIV infection

and AIDS e.g. ritonavir

medicines used to relieve

stomach cramps or spasms, to

prevent travel sickness

medicines to treat Parkinson's

disease

medicines to treat urinary

incontinence

medicines used to relax muscles

St John's wort (a herbal

preparation)

TARGIN

TABLETS MFCTARGI11017 (SUPERSEDES MFCTARGI10716)

grapefruit and grapefruit juice.

These medicines, dietary

supplements or alcohol may affect

how well TARGIN tablets work, or

may increase side effects. You may

need to avoid these or use different

amounts, or take different medicines.

While you are taking this medicine

for restless legs syndrome your

doctor may reduce your dose if you

are taking TARGIN tablets and

Rotigotine, a medicine used to treat

Parkinson's disease.

Your doctor or pharmacist has more

information on medicines and dietary

supplements to be careful with or

avoid while taking this medicine.

How to take TARGIN

tablets

How much to take

Your doctor will tell you exactly how

much to take.

Follow the instructions given to

you by your doctor or pharmacist

exactly.

How to take it

Swallow TARGIN tablets whole

with a full glass of water.

Do not chew, crush, break or

dissolve the tablets.

TARGIN tablets are only designed to

work properly if swallowed whole.

The tablets may release all their

contents at once if chewed, crushed,

broken or dissolved which can be

dangerous and cause serious

problems, such as an overdose which

may be fatal.

If you have trouble swallowing your

tablets whole, talk to your doctor.

You must only take TARGIN

tablets by mouth.

Taking this medicine in a manner

other than that prescribed by your

doctor can be harmful to your health.

When to take it

Take TARGIN tablets every 12

hours.

Take TARGIN tablets regularly to

control the pain or to relieve the

symptoms of restless legs syndrome.

Taking them at the same time each

day will assist in ensuring the best

effect in improving your pain. If

however, you begin to experience

worsening pain or symptoms and

you are taking your TARGIN

tablets as prescribed, contact your

doctor as your dosage may need to

be reviewed.

You may take this medicine with or

without food.

How long to take it

Continue taking your medicine for

as long as your doctor tells you.

If you stop taking this medicine

suddenly, your pain or symptoms

may worsen and you may experience

withdrawal symptoms such as:

body aches

loss of appetite, nausea, stomach

pain or diarrhoea

fast heart rate

sneezing or runny nose

chills, tremors, shivering or fever

trouble with sleeping

increased sweating and yawning

weakness

nervousness or restlessness.

If you forget to take it

If you forget to take your tablets,

contact your doctor or pharmacist

for advice.

Do not take a double dose to make

up for the dose that you missed.

This will increase the chance of you

getting unwanted side effects.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

when to take your tablets, ask your

pharmacist for some hints.

For example, take your medicine at

the same time each morning and

evening such as 8 a.m. and 8 p.m.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(Australia: telephone 13 11 26) for

advice, or go to Accident and

Emergency at your nearest

hospital, if you think that you or

anyone else may have taken too

many TARGIN tablets.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

Keep telephone numbers for these

places handy.

You should also follow the above

steps if someone other than you has

taken the tablets that were prescribed

for you.

If someone takes an overdose they

may experience difficulties in

breathing, become drowsy and tired,

lack muscle tone, have cold or

clammy skin, have constricted pupils,

have very low blood pressure or slow

heart rate and may even become

unconscious or die.

When seeking medical attention, take

this leaflet and any remaining tablets

with you to show the doctor. Also

report any other medicines or alcohol

which have been taken.

While you are taking

TARGIN

Things you must do

Take TARGIN tablets exactly as

your doctor has prescribed.

Before you start on a new

medicine, remind your doctor and

pharmacist that you are taking

TARGIN tablets.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this medicine.

TARGIN

TABLETS MFCTARGI11017 (SUPERSEDES MFCTARGI10716)

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

It may affect other medicines used

during surgery.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Keep all of your doctor's

appointments so that your progress

can be checked.

Tell your doctor if your pain is

getting worse, or if you are having

more frequent breakthrough pain.

Also tell your doctor if you are

having any problems or difficulties

while you are being treated with

TARGIN tablets.

Tolerance to oxycodone may develop

which means that the effect of the

medicine may decrease. If this

happens, your doctor may review

your dose so that you get adequate

pain relief.

Keep enough TARGIN tablets with

you to last over weekends and

holidays.

Things you must not do

Do not drink alcohol while you are

taking TARGIN tablets.

Drinking alcohol while taking

TARGIN tablets may make you feel

more sleepy and increase the risk of

serious side effects, such as shallow

breathing with the risk of stopping

breathing and loss of consciousness.

Do not take TARGIN tablets to

treat any other complaint unless

your doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not stop taking your medicine

or change the dosage without

checking with your doctor.

Over time your body may become

used to you taking oxycodone so if

you stop taking it suddenly, your

pain may worsen and you may have

unwanted side effects such as

withdrawal symptoms. This is called

physical dependence.

If you need to stop taking this

medicine, your doctor will gradually

reduce the amount you take each day,

if possible, before stopping the

medicine completely.

Things to be careful of

Do not drive or operate machinery

until you know how TARGIN

tablets affect you.

TARGIN tablets may cause episodes

of suddenly falling asleep,

drowsiness, dizziness, hallucinations,

disorientation, blurred vision or other

vision problems or may affect

alertness. If you are affected, you

should not drive or operate

machinery. Discuss these effects with

your doctor.

If you have been switched to

TARGIN tablets from other opioid

pain medications and are taking

laxatives, you may need to reassess

your laxative treatment.

It may be appropriate to reduce your

laxative intake when you start taking

TARGIN tablets and throughout your

TARGIN tablet therapy.

Be careful if you are elderly,

unwell or taking other medicines.

Some people may experience side

effects such as drowsiness,

confusion, dizziness and unsteadiness

which may increase the risk of a fall.

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly will help your

body get used to the change in

position and blood pressure. If this

problem continues or gets worse, talk

to your doctor.

Tell your doctor if you suffer from

nausea or vomiting when taking

TARGIN tablets.

If you vomit after your dose, your

pain may come back, as you will not

have absorbed your medicine. If this

happens, speak to your doctor. Your

doctor may prescribe some medicine

to help you stop vomiting.

Do not be alarmed if you see

remnants of the tablet in your

stool.

The active substances have already

been released in the stomach and gut,

and absorbed into your body.

There is potential for abuse of

oxycodone and the development of

addiction to oxycodone. It is

important that you discuss this

issue with your doctor.

Be aware that TARGIN tablets

may produce a positive result in

sports agency drug testing.

Side effects

All medicines may have some

unwanted side effects. Sometimes

they are serious, but most of the time

they are not. As for other medicines

of this type, that is opioid analgesics,

many side effects tend to reduce over

time. This means that the longer you

take this medicine, the less it may

cause problems for you. Your doctor

has weighed the risks of this

medicine against the benefits they

expect it will have for you.

Do not be alarmed by this list of

possible side effects.

Not everybody experiences them.

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking TARGIN

tablets.

This medicine helps most people

with moderate to severe pain, but it

may have unwanted side effects in a

few people. Other side effects not

listed here may also occur in some

people.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you:

mild abdominal problems such as

diarrhoea, feeling sick (nausea),

decreased appetite, constipation

TARGIN

TABLETS MFCTARGI11017 (SUPERSEDES MFCTARGI10716)

dry mouth, hiccups, sore throat,

thirst, trouble swallowing or

changes in voice

feeling anxious or nervous,

trouble sleeping or abnormal

dreams

trouble with your balance

excessive sweating, hot flushes

restlessness

muscle problems such as spasms,

twitching or tremors

fatigue and feeling of tiredness

skin rash, itching, chills, or fever

new problems with your eyesight

swelling of legs and ankles

absence of menstrual period

impotence

decreased sexual drive.

Tell your doctor as soon as possible

if you notice any of the following

and they worry you:

stomach discomfort, vomiting,

indigestion or abdominal pain

abnormal thinking or changes in

mood, or feeling deep sadness

slow or noticeable heart beats

headache or confusion

drowsiness, feeling faint or

fainting or dizziness especially

when standing up

unusual weakness, loss of

strength or trouble walking

urinary tract infections or change

in passing urine such as the

volume passed, pain or feeling

the need to urinate urgently.

The above list includes serious side

effects that may require medical

attention.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

you have an allergic reaction:

shortness of breath, wheezing,

shallow or difficulty breathing;

swelling of the face, lips, tongue,

throat or other parts of the body;

rash, itching or hives on the skin

your breathing slows or weakens

chest pain or chest tightness

fast or irregular heartbeats

seizures, fits or convulsions.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

After taking TARGIN

Storage

Keep your tablets in the blister

pack until it is time to take them.

If you take the tablets out of the

blister pack they may not keep as

well.

Keep your tablets in a cool, dry

place where the temperature stays

below 25°C.

Do not store it or any other

medicine in the bathroom, near a

sink or on a window sill.

Do not leave it in the car.

Heat and damp can destroy some

medicines.

Keep it 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 tells you to stop

taking the tablets or the tablets

have passed their expiry date,

return any unused medicine to

your pharmacist.

Product description

What it looks like

TARGIN

tablets are modified

release film-coated tablets. They are

available in seven strengths which

are as follows*:

2.5/1.25 mg - round, light yellow

with no markings

5/2.5 mg - oblong, blue, marked

"OXN" on one side and "5" on the

other

10/5 mg - oblong, white, marked

"OXN" on one side and "10" on the

other

15/7.5 mg - oblong, grey, marked

"OXN" on one side and "15" on the

other

20/10 mg - oblong, pink, marked

"OXN" on one side and "20" on the

other

30/15 mg - oblong, brown, marked

"OXN" on one side and "30" on the

other

40/20 mg - oblong, yellow, marked

"OXN" on one side and "40" on the

other.

60/30 mg - oblong, red, marked

"OXN" on one side and "60" on the

other

80/40 mg - oblong, brown, marked

"OXN" on one side and "80" on the

other

*Not all strengths are marketed in

Australia

TARGIN

tablets come in boxes

containing blister packs of 28 tablets.

Ingredients

Active ingredients:

2.5/1.25 mg contains 2.5 mg

oxycodone hydrochloride and

1.25 mg naloxone hydrochloride

5/2.5 mg contains 5 mg

oxycodone hydrochloride and 2.5

mg naloxone hydrochloride

10/5 mg contains 10 mg

oxycodone hydrochloride and 5

mg naloxone hydrochloride

15/7.5 mg contains 15 mg

oxycodone hydrochloride and 7.5

mg naloxone hydrochloride

20/10 mg contains 20 mg

oxycodone hydrochloride and 10

mg naloxone hydrochloride

30/15 mg contains 30 mg

oxycodone hydrochloride and 15

mg naloxone hydrochloride

TARGIN

TABLETS MFCTARGI11017 (SUPERSEDES MFCTARGI10716)

40/20 mg contains 40 mg

oxycodone hydrochloride and 20

mg naloxone hydrochloride.

60/30 mg contains 60 mg

oxycodone hydrochloride and 30

mg naloxone hydrochloride.

80/40 mg contains 80 mg

oxycodone hydrochloride and 40

mg naloxone hydrochloride.

Inactive ingredients:

lactose

hyprolose (2.5/1.25mg, 5/2.5mg

and 15/7.5mg tablets)

povidone (10/5mg, 20/10mg,

30/15mg, 40/20mg, 60/30 mg and

80/40 mg tablets)

ethylcellulose

stearyl alcohol

purified talc

magnesium stearate

polyvinyl alcohol

titanium dioxide

macrogol 3350

brilliant blue FCF (CI42090)

(5/2.5mg tablets)

iron oxide red (CI77491)

(2.5/1.25mg, 15/7.5mg, 20/10mg

30/15mg and 60/30 mg tablets)

iron oxide yellow (CI77492)

(2.5/1.25mg, 15/7.5mg, 30/15mg

40/20mg and 80/40 mg tablets )

iron oxide black (CI77499)

(15/7.5mg, 30/15mg, 60/30 mg

and 80/40 mg tablets).

This medicine does not contain

sucrose, gluten, tartrazine or any

other azo dyes.

Supplier

TARGIN

tablets are supplied in

Australia by:

Mundipharma Pty Limited

ABN 87 081 322 509

88 Phillip Street

Sydney NSW 2000

Phone: 1800 188 009

® TARGIN is a registered trade

mark.

This leaflet was updated in October

2017.

Please check with your pharmacist

that this is the latest version of the

leaflet available.

Australian Registration Numbers for

TARGIN

tablets are:

2.5/1.25 mg AUST R 216260

5/2.5 mg AUST R 156067

10/5 mg AUST R 156145

15/7.5 mg AUST R 216261

20/10 mg AUST R 156189

30/15 mg AUST R 216280

40/20 mg AUST R 156194

60/30 mg AUST R 243252

80/40 mg AUST R 243272

Orbis AU-4212

TARGIN

TABLETS MFCTARGI11017 (SUPERSEDES MFCTARGI10716)

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

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FDA - U.S. Food and Drug Administration

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

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

10-8-2018

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

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

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

21-3-2018

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Monopar Therapeutics SARL)

EU/3/11/919 (Active substance: Clonidine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)1817 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/11/T/02

Europe -DG Health and Food Safety