PAROXETINE

Main information

  • Trade name:
  • PAROXETINE GH paroxetine (as hydrochloride) 20mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PAROXETINE GH paroxetine (as hydrochloride) 20mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219043
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219043

PAROXETINE GH paroxetine (as hydrochloride) 20mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

18/12/2014

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. PAROXETINE GH paroxetine (as hydrochloride) 20mg tablet blister pack

Product Type

Single Medicine Product

Effective date

11/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of major depression; it is effective in preventing the relapse of depressive symptoms. Treatment of obsessive compulsive disorder (OCD) ; It is

effective in preventing relapse of OCD. Treatment of panic disorder and prevention of relapse of panic disorder. Treatment of social anxiety

disorder/social phobia.

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

30 Tablets

(S4) Prescription Only Medicine

Components

1. PAROXETINE GH paroxetine (as hydrochloride) 20mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, round bi-sected film-coated tablet with a one-sided breaking notch

("Snap-tab") and embossment 'PX 20' on opposite side, intact surface.

Active Ingredients

paroxetine hydrochloride

22.2 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 04:01:09 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

PAROXETINE GH

CONSUMER MEDICINE INFORMATION

Paroxetine GH

paroxetine hydrochloride tablets

WHAT IS IN THIS

LEAFLET?

Please read this leaflet carefully

before you take Paroxetine GH

tablets

This leaflet answers some common

questions about Paroxetine GH.

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 expected benefits of you taking

Paroxetine GH against the risks this

medicine could 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 IS PAROXETINE GH

USED FOR?

The name of your medicine is

Paroxetine GH. It contains the active

ingredient paroxetine hydrochloride.

Paroxetine hydrochloride belongs to

a group of medicines called selective

serotonin reuptake inhibitor (SSRI)

antidepressants. They are thought to

work by their action on brain

chemicals called amines which are

involved in controlling mood.

Depression is longer lasting and/or

more severe than the "low moods"

everyone has from time to time. 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. You may feel

low in spirit, lose interest in usual

activities, unable to enjoy life, have

poor appetite or overeat, have

disturbed sleep, often waking up

early, low energy and feel guilty over

nothing.

Paroxetine GH may also be used to

treat:

Patients who may avoid and/or

are fearful of social situations.

Symptoms of panic attacks.

When taken regularly it will help

prevent the attacks.

Obsessive compulsive disorder

(OCD). The symptoms of OCD

vary from patient to patient.

Check with your doctor if you

need more information.

Your doctor may decide that you

should continue to use Paroxetine

GH for some time, even when you

have overcome your problem. This

should prevent the problem from

returning.

Your doctor may have prescribed

Paroxetine GH for another use. Ask

your doctor if you have questions

about why Paroxetine GH has been

prescribed for you.

BEFORE YOU TAKE

PAROXETINE GH

Antidepressants can increase suicidal

thoughts and actions in some

children and adolescents younger

than 18 years of age. But suicidal

thoughts and actions can also be

caused by depression, a serious

medical condition that is commonly

treated with antidepressants.

Thinking about killing yourself or

trying to kill yourself is called

suicidality or being suicidal.

Antidepressants are used to treat

depression and other illnesses.

Depression and other illnesses can

lead to suicide. In some children and

adolescents, treatment with an

antidepressant increases suicidal

thinking or actions. It is important to

discuss all the risks of treating

depression and also the risks of not

treating it. You should discuss all

treatment choices with your doctor,

not just the use of antidepressants.

Patients (and caregivers of patients)

need to monitor for any worsening

of their condition and/or the

emergence of thoughts of suicide or

suicidal behaviour or thoughts of

harming themselves and to seek

medical advice immediately if these

symptoms present. (See Use In

Children and Adolescents).

Do not take if:

You must not take Paroxetine GH if:

you have ever had an allergic

reaction to paroxetine

hydrochloride or to any of the

other ingredients listed toward

the end of this leaflet (see

“Ingredient”).

you are pregnant or intend to

become pregnant.

Studies show that use of

paroxetine in early pregnancy

(first 13 weeks) may be

associated with an increased risk

of some birth defects in babies. If

you become pregnant or intend

to become pregnant while taking

paroxetine, you should make an

appointment to see your doctor

and have your treatment

reviewed. It is important that you

do not stop taking paroxetine

suddenly. Paroxetine is a

medicine that can have

withdrawal side effects if

1508 PAROXETINE GH CMI V2

stopped suddenly (see

“Unwanted events that may

occur on stopping treatment”).

You are taking any other

medication for the treatment of

depression or have done so in

the last two weeks. Taking

Paroxetine GH with another

antidepressant may cause a

serious reaction.

You must not take Paroxetine GH

until two weeks after stopping

monoamine oxidase inhibitor

drugs (MAOIs). Examples of

MAOIs are phenelzine and

tranylcypromine. Another MAOI

includes the antibiotic linezolid.

There may be others so please

check with your doctor. Taking

Paroxetine GH with a MAOI may

cause a serious reaction.

You are taking or have recently

taken (within the last two weeks)

a medicine called

methylthioninium chloride

(methylene blue).

You are taking thioridazine for

the treatment of schizophrenia.

You have taken Paroxetine GH

before and became unwell.

Tell your doctor or pharmacist

before taking the first dose.

you are taking pimozide.

The expiry date (EXP) printed on

the pack has passed.

The packaging is torn or shows

signs of tampering.

Take special care with Paroxetine GH

if you are over 65 years of age as

Paroxetine GH may cause a

reduction in the amount of sodium

within your blood which can lead to

sleepiness and muscle weakness. If

you experience these symptoms,

please consult your doctor as soon

as possible.

Medicines like Paroxetine GH may

affect your sperm. Fertility in some

men may be reduced while taking

Paroxetine GH.

Tell your doctor if:

You must tell your doctor if:

you are allergic to foods, dyes,

preservatives or any other

medicines

you are pregnant or intend to

become pregnant

you are breastfeeding or wish to

breastfeed.

Your doctor will discuss with you

the possible risks and benefits of

using Paroxetine GH during

breastfeeding.

you have any medical conditions:

- epilepsy (fits)

- mania

- heart problems

- kidney problems

- liver problems

- raised pressure in the eye

- problems with blood clotting

- other psychiatric conditions

(bipolar disorder).

- diabetes

you are taking any other

medicines, including medicines

you buy without a prescription.

In particular tell your doctor if

you are taking any of the

following medicines which:

- treat depression, anxiety,

mood swings or schizophrenia,

including medicines you buy

without a doctor's prescription

such as tryptophan, hypericum

perforatum (St John's Wort),

perphenazine, risperidone,

lithium or atomoxetine.

- are used in anaesthesia or to

treat pain or chronic pain,

specifically tramadol or fentanyl.

- lower blood pressure or treat

heart conditions such as

metoprolol or flecainide.

- control epilepsy (anti-

convulsants), such as phenytoin,

carbamazepine, phenobartbital.

- thin blood (anti-coagulants),

such as warfarin, aspirin and

non-steroidal anti-inflammatory

drugs (NSAIDs).

- treat Parkinson's disease, such

as selegiline, procyclidine.

- treat stomach ulcers, such as

cimetidine.

- treat migraine attack, such as

sumatriptan

- treat or prevent breast breast

cancer, specifically tamoxifen.

- treat HIV infection such as a

combination of fosamprenavir

and ritonavir.

- Used in anaesthesia, such as

mivacurium and

suxamethonium.

Some medicines may affect the way

other medicines work. Your doctor

or pharmacist will be able to tell you

which medicines are safe to take

with Paroxetine GH...

HOW DO I TAKE

PAROXETINE GH?

Follow your doctor's instructions

about how and when to take

Paroxetine GH.

Read the direction label carefully. If

you have any concerns about how to

take Paroxetine GH, talk to your

doctor or pharmacist.

How much to take

The usual dose of Paroxetine GH for

depression or social anxiety

disorder/social phobia is one tablet

(paroxetine 20mg) per day. Your

doctor may increase the dose slowly

over several weeks. This may require

you to break the tablet in half.

To treat obsessions and compulsions

or panic attacks, the usual dose of

Paroxetine GH is two 20mg tablets

per day. Your doctor may start you

on a lower dose (half a tablet) and

increase the dose slowly over several

weeks. This may require you to

break the tablet in half.

1508 PAROXETINE GH CMI V2

How to take it

Take Paroxetine GH with a full glass

of water or another liquid. The

tablets can be broken in half, but

should not be chewed.

If you need to break Paroxetine GH,

place the tablet on a flat surface

with the notch side facing up and

press down on the scored side with

the thumb.

Paroxetine GH should be taken in

the morning, preferably with food.

How long to take Paroxetine GH

Keep taking Paroxetine GH for as

long as your doctor tells you.

Like other medications of this type,

Paroxetine GH will not relieve your

symptoms straight away. People

generally start feeling better in a few

weeks or so. 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. 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/other symptoms at any

time during your treatment.

Stopping treatment

Do not stop taking Paroxetine GH

even if you begin to feel better. Your

doctor may decide that you should

continue to use Paroxetine GH for

some time, even when you have

overcome your problem. For best

effect Paroxetine GH must be taken

regularly. Your doctor will tell you

when and how Paroxetine GH 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 Paroxetine GH,

especially if this is done suddenly,

you may experience unwanted

symptoms. Please see the section of

this leaflet called "Unwanted Effects

that may occur on stopping

treatment".

Use in children and adolescents

Paroxetine GH is not recommended

for use in children and adolescents

under 18 years.

The use of Paroxetine GH is not

recommended to treat depression in

children and adolescents under 18,

as the drug has not been shown to

be effective in this age group and

there are possible unwanted effects.

Information from clinical trials has

suggested that young adults,

particularly those with depression,

may be at an increased risk of

suicidal behaviour (including suicide

attempts) when treated with

paroxetine, especially during initial

treatment (generally the first one to

two months). The majority of

attempted suicides in clinical trials in

depression involved patients aged 18

to 30 years.

Family and caregivers of children and

adolescents being treated with

antidepressants for major depressive

disorder or for any other condition

(psychiatric or non-psychiatric) need

to monitor them for the emergence

of agitation, irritability, unusual

changes in behaviour, as well as the

emergence of thoughts of suicide,

and to report such symptoms

immediately to their doctor. It is

particularly important that

monitoring be undertaken during

the initial few months of

antidepressant treatment or at times

of dose increase or decrease.

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 try to make up for the dose

that you missed by taking more than

one dose at a time.

WHAT DO I DO IF I TAKE

TOO MUCH? (OVERDOSE)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26 or New Zealand

0800 POISON or 0800 764766) for

advice, or go to Accident and

Emergency at the nearest hospital,

if you think you or anyone else may

have taken too much Paroxetine

GH. Do this even if there are no

signs of discomfort or poisoning.

If you are not sure what to do,

contact your doctor or pharmacist.

WHILE YOU ARE TAKING

PAROXETINE GH

Things you must do

Tell your doctor if, for any reason,

you have not taken your medicine

exactly as directed.

Otherwise, your doctor may think

that it was not effective and change

your treatment unnecessarily.

Things you must not do

Do not take Paroxetine GH to treat

any other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if their symptoms

seem similar to yours.

Things to be careful of

Be careful driving or operating

machinery until you know how

Paroxetine GH affects you. Tests

have shown that AROPAX does

not have a marked effect on

driving ability.

However Paroxetine GH may

cause drowsiness, dizziness or

light-headedness in some people.

Make sure you know how you

react to Paroxetine GH before

you drive, operate machinery.

Although drinking moderate

amounts of alcohol is unlikely to

1508 PAROXETINE GH CMI V2

affect your response to

Paroxetine GH, it is best to avoid

alcohol while you are taking this

medicine.

There is an increased risk of

breaking a bone in people taking

medicines like Paroxetine GH.

This risk is greatest during the

early stages of treatment.

When your doctor decides that

you should stop taking

Paroxetine GH, the dose may be

reduced slowly or the time

between doses increased over

one or two weeks. Some people

may have symptoms such as

dizziness, anxiety, sleep

disturbances, pins and needles,

electric shock sensations or

feeling sick and sweating if

Paroxetine GH is stopped,

particularly if stopped suddenly.

Although Paroxetine GH is not

recommended for children under

18 years of age, additional

symptoms that have been

experienced by children whilst

stopping treatment are

abdominal pain, nervousness and

mood changes.

WHAT ARE THE SIDE

EFFECTS?

Check with your doctor as soon as

possible if you think you are

experiencing any side effects or

allergic reactions due to taking

Paroxetine GH, even if the problem

is not listed below.

Like other medicines, Paroxetine GH

can cause some side effects. If they

occur, they are most likely to be

minor and temporary. However,

some may be serious and need

medical attention.

MILD EFFECTS:

Tell your doctor if you notice any of

the following that are troublesome

or ongoing:

bruising

drowsiness, dizziness, difficulty in

getting to sleep

feeling sick, dry mouth,

constipation, decreased

appetite, nausea, diarrhoea

vomiting

feeling sweaty or shaky

impaired sexual function

weakness

abnormal dreams (including

nightmares)

weight gain

MORE SERIOUS EFFECTS

Tell your doctor immediately if you

notice any of the following:

muscle spasms or twitches

Stop taking Paroxetine GH and

contact your doctor or go to

emergency department of your

nearest hospital if any of the

following happens:

allergic reaction including

swelling of the limbs, face, lips,

mouth or throat which may

cause difficulty in swallowing or

breathing

skin rash, which may blister, and

looks like small targets (central

dark spots surround by a paler

area, with a dark ring around

the edge) called erythema

multiforme

a widespread rash with blisters

and peeling skin, particularly

around the mouth, nose, eyes

and genitals (Stevens-Johnson

syndrome)

a widespread rash with blisters

and skin peeling on much of the

body surface (toxic epidermal

necrolysis)

sudden onset of prolonged

muscular spasm, affecting the

eyes, head, neck and body

sudden increase in body

temperature, severe

convulsions

fast heartbeat, sweating, muscle

spasm, racing thoughts,

restlessness

Other rare events that have been

reported with paroxetine include:

blurred vision

abnormal liver function

low levels of sodium in the blood,

especially in older people

bleeding disorders, including

nose bleeds and gastrointestinal

bleeding which occurs very

rarely

hormone disturbances

mood of excitement, over-

activity and uninhibited

behaviour

confusion

seizures

rash caused by light

itch rash, hives, swelling of the

face, lips, mouth, tongue or throat

Akathisia (restlessness or

difficulty keeping still, caused by

medicines to treat mental

disorders

irresistible urge to move the legs

(Restless Legs Syndrome)

menstrual period disorder

(including heavy periods,

bleeding between periods and

absence of periods.

Severe allergic reactions

Unwanted Effects that may occur on

stopping treatment:

Symptoms may include:

dizziness

sensory disturbances such as,

pins and needles, burning

sensations, electric shock like

sensations

sleep disturbance, including

intense dreams

agitation or anxiety

feeling sick

shaking or tremors

confusion

sweating

headache

diarrhoea.

1508 PAROXETINE GH CMI V2

These are likely to occur in the first

few days of stopping treatment or

very rarely if you miss a dose.

However, they are more likely to

occur if you stop taking Paroxetine

GH too quickly. Therefore always

consult your doctor before stopping

your medicine. For the majority of

patients, symptoms go away on their

own within a few weeks. However, if

you feel that the unwanted

symptoms are too severe, see your

doctor who will suggest how to

manage stopping treatment more

slowly.

Additional symptoms that have been

experienced by children whilst

stopping treatment are changing

emotions (including thoughts of

suicide, attempting suicide, mood

changes and feeling tearful),

abdominal pain and nervousness.

Tell your doctor immediately if you

notice any of the following:

Wheezing, swelling of the

lips/mouth, difficulty in

breathing, hayfever, lumpy rash

(hives) or fainting. These could

be a symptom of an allergic

reaction

Although Paroxetine GH is not

recommended for children under

the age of 18 years, the most

common unwanted effects in

children under 18 are:

decreased appetite

tremor (uncontrollable

trembling)

sweating

hyperactivity

hostile/unfriendly behaviour

agitation

changing emotions including

crying, changes in mood, trying

to harm themselves, thoughts of

suicide and attempting suicide.

This is not a complete list of all

possible side effects. Others may

occur in some people and there may

be some side effects not yet known.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

HOW DO I STORE

PAROXETINE GH?

Storage

Keep your medicine in the original

container.

If you take it out of its original

container it may not keep well.

Keep your medicine in a cool dry

place where the temperature stays

below 25°C.

Do not store Paroxetine GH 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 it where children cannot reach

it, such as in a locked cupboard.

Disposal

If your doctor tells you to stop taking

this medicine or the expiry date has

passed, ask your pharmacist what to

do with any medicine that is left

over.

PRODUCT DESCRIPTION

What it looks like

Paroxetine GH 20mg - round white

tablets with a score notch on one

side and embossed with 'PX 20' on

the other side.

Available in blisters packs of 30

tablets.

Ingredients

Active ingredient:

Paroxetine GH 20mg - 20mg

paroxetine (as hydrochloride).

Inactive ingredients:

colloidal anhydrous silica

crospovidone

hypromellose

mannitol

microcrystalline cellulose

purified talc

sodium starch glycollate

magnesium stearate

titanium dioxide.

This medicine does not contain

lactose, sucrose, gluten, tartrazine or

any other azo dyes.

Distributor

Generic Health Pty Ltd

Level 1, 1102 Toorak Road

Camberwell VIC 3124

Australia

This leaflet was prepared in August

2015.

Australian Registration Numbers

20mg film-coated tablets: AUST R

219043

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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