DULOXECOR

Main information

  • Trade name:
  • DULOXECOR duloxetine hydrochloride 30 mg enteric capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DULOXECOR duloxetine hydrochloride 30 mg enteric capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209155
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209155

DULOXECOR duloxetine hydrochloride 30 mg enteric capsule 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

5/06/2014

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. DULOXECOR duloxetine hydrochloride 30 mg enteric capsule blister pack

Product Type

Single Medicine Product

Effective date

9/02/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

DULOXETINE is indicated for the treatment of major depressive disorder (MDD).,DULOXETINE is indicated for the treatment of diabetic peripheral

neuropathic pain (DPNP).,DULOXETINE is indicated for the treatment of generalised anxiety disorder (GAD).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PCTFE

(Aclar)/Al

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

28 (2 blisters x 14 capsules)

(S4) Prescription Only Medicine

Components

1. DULOXECOR duloxetine hydrochloride 30 mg enteric capsule blister pack

Dosage Form

Capsule, enteric

Route of Administration

Oral

Visual Identification

White to off white enteric coated pellets filled in size 2 HGC, white

body&blue-cap printed "Dulox" on cap in white ink and 30 mg on body in

black ink

Active Ingredients

Duloxetine hydrochloride

33.66 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 10:45:53 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Duloxecor CMI 1

DULOXECOR

(duloxetine hydrochloride)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about DULOXECOR. It

does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date shown on

the final page. More recent

information on this medicine may be

available. Make sure you speak to

your pharmacist or doctor to obtain

the most up to date information on

this medicine.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking

DULOXECOR 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 DULOXECOR

is

used for

DULOXECOR is used to treat major

depressive disorder (depression),

Diabetic Peripheral Neuropathic Pain

(nerve pain caused by diabetes) and

Generalised Anxiety Disorder

(excessive worry)

DULOXECOR belongs to a group of

medicines called Serotonin and

Noradrenaline Reuptake Inhibitors

(SNRIs). SNRIs are believed to work

by their action on serotonin and

noradrenaline in the brain. Serotonin

and noradrenaline are the chemical

messengers responsible for

controlling the psychological and

painful physical symptoms of

depression.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed it for

another reason.

This medicine is available only with

a doctor's prescription.

DULOXECOR is not recommended

for use in children and adolescents

under the age of 18 years.

Before you take

DULOXECOR

When you must not take it

Do not take DULOXECOR if you

have an allergy to:

any medicine containing

duloxetine hydrochloride;

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 DULOXECOR if you

have liver disease.

This

could

increase

chance

you having liver problems during

treatment with DULOXECOR.

Do not take this medicine if you

are taking another medicine for

depression called a monoamine

oxidase inhibitor (MAOI) or have

been

taking

a

MAOI

within

the

last

14

days.

Check

with

your

doctor or pharmacist if you are

unsure as to whether or not you

are taking a MAOI.

If

you

do

take

DULOXECOR

while you are taking a MAOI, you

may experience shaking (tremor),

shivering, muscle stiffness, fever,

rapid pulse, rapid breathing or

confusion.

Do not take DULOXECOR if you

are taking another medicine for

depression called fluvoxamine.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

expired

damaged,

return

your

pharmacist

disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

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 if you have:

a condition in which the pressure

of fluid in the eye may be high

(glaucoma)

high blood pressure

heart problems

kidney problems as you may need

take

lower

dose

DULOXECOR

history of fits (seizures)

bipolar disorder

diabetes

If you have high blood pressure or

heart problems your doctor may

monitor your blood pressure.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-feeding.

Duloxecor CMI 2

Your doctor can discuss with you the

risks and benefits involved. If

DULOXECOR

taken

during

pregnancy,

should

careful,

particularly at the end of pregnancy.

Transitory

withdrawal

symptoms

have

been

reported

rarely

newborn after

maternal use in

last 3 months of pregnancy.

Talk to your doctor about how

much alcohol you drink. People

who drink excessive amounts of

alcohol should not take

DULOXECOR.

Drinking too much alcohol could

increase the chance of you having

liver problems during treatment with

DULOXECOR.

If you have not told your doctor

about any of the above, tell them

before

you

start

taking

DULOXECOR.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and DULOXECOR

may interfere with each other. These

include:

monoamine oxidase inhibitors

(MAOIs), medicines used to treat

some types of depression.

You should stop taking MAOIs

at least two weeks before

starting DULOXECOR.

You must stop taking

DULOXECOR at least 5 days before

you start taking a MAOI.

other medicines used to treat

depression, panic disorder,

anxiety or obsessive illnesses,

including tryptophan

strong painkillers such as

tramadol, pethidine

a type of migraine treatment

called 'triptans', such as

sumatriptan or zolmitriptan

medicines used to treat stress

urinary incontinence such as

tolteridone

medicines used to treat heart

problems such as flecainide or

propafenone

thioridazine, a medicine used to

treat schizophrenia

herbal medicines such as St

John's Wort (Hypericum

perforatum)

warfarin, a medicine used to thin

the blood (anticoagulant) or other

medicines known to affect blood

coagulation (NSAIDs, aspirin)

Do not start to take any other

medicine unless prescribed or

approved by your doctor.

These medicines may be affected by

DULOXECOR

affect

well

works.

need

different amounts of your medicines

or you may need to take different

medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take

DULOXECOR

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the carton, ask

your doctor or pharmacist for

help.

How much to take

The usual recommended dose of

DULOXECOR in

Major Depressive Disorder or

Diabetic Peripheral Neuropathic Pain

is one 60 mg capsule taken once

daily.

recommended

dose

DULOXECOR

Generalised

Anxiety Disorder is between 30 mg

and 120 mg, taken once daily.

Your

doctor

start

lower

dose

help

reduce

side

effects.

If you have severe kidney disease,

the recommended starting dose of

DULOXECOR is one 30 mg

capsule taken once daily.

How to take it

Swallow the capsule whole with a

full glass of water.

Do

not

open

the

capsules

and

crush the pellets inside because the

medicine may not work as well.

DULOXECOR may be taken with or

without meals.

When to take it

Take your medicine at about the

same time each day.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

How long to take it

The length of treatment with

DULOXECOR will depend on how

quickly your symptoms improve.

Most medicines of this type take

time to work so don't be discouraged

if you do not feel better right away.

Although you may notice an

improvement, continue taking

your medicine for as long as 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.

Otherwise, take it as soon as you

remember, and then go back to

taking your medicine as you would

normally.

Duloxecor CMI 3

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 have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your

doctor or the Poisons Information

Centre (telephone 13 11 26) for

advice, or go to Accident and

Emergency at the nearest hospital,

if you think that you or anyone

else may have taken too much

DULOXECOR.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

Symptoms of an overdose may

include drowsiness, convulsions, and

vomiting. Symptoms may also

include some or all of the following:

feeling confused, feeling restless,

sweating, shaking, shivering,

hallucinations, muscle jerks, fast

heart beat.

While you are taking

DULOXECOR

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking DULOXECOR.

Tell

any

other

doctors,

dentists

and

pharmacists

who

treat

you

that you are taking this medicine.

If you are going to have surgery,

tell

the

surgeon

or

anaesthetist

that you are taking this medicine

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.

Your doctor may do some tests from

time to time to make sure the

medicine is working and to prevent

unwanted side effects.

Tell your doctor immediately if

you have any suicidal thoughts or

other mental/ mood changes.

Occasionally, the symptoms of

depression or other psychiatric

conditions may include thoughts of

harming yourself or committing

suicide. These symptoms may

continue or get worse during the first

one or two months of treatment, until

the full antidepressant effect of the

medicine becomes apparent. This is

more likely to occur in young adults

under 25 years of age.

Contact your doctor or a mental

health professional right away or

go to the nearest hospital for

treatment if you or someone you

know is showing any of the

following warning signs of suicide:

worsening of your depression

thoughts or talk of death or

suicide

thoughts or talk of self-harm or

harm to others

any recent attempts of self-harm

increase in aggressive behaviour,

irritability or any other unusual

changes in behaviour or mood.

All mentions of suicide or violence

must be taken seriously.

If you notice any of the following

contact your doctor right away.

Your doctor may do some blood tests

to check your liver or tell you to stop

taking your medicine. Signs of liver

problems include:

itchy skin

dark urine

yellowing of the skin or eyes

tenderness over the liver

symptoms of the 'flu'

These may be signs of serious liver

damage.

Things you must not do

Do not take DULOXECOR to

treat any other complaints 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 DULOXECOR

or lower the dosage without

checking with your doctor.

If you stop taking it suddenly, your

condition may worsen or you may

have unwanted side effects. If

possible, your doctor will gradually

reduce the amount you take each day

before stopping the medicine

completely.

Do not drive or use machine

until

you

know

how

DULOXECOR affects you.

DULOXECOR may cause dizziness

or drowsiness in some people.

Do not let yourself run out of

DULOXECOR over the weekend

or on holidays.

Things to be careful of

Be careful when drinking alcohol

while you are taking this medicine.

Drinking large amounts of alcohol

during treatment with

DULOXECOR can cause severe

liver injury.

You should avoid 'binge drinking'

or drinking excessively during

treatment with DULOXECOR.

Drinking alcohol with this medicine

may also cause dizziness or

drowsiness in some people. If you

have any of these symptoms, do not

drive, use machine or do

anything else that could be

dangerous.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

Duloxecor CMI 4

well

while

you

are

taking

DULOXECOR.

This medicine helps many people

with depression, but it may have

unwanted side effects in a few

people. All medicines can have side

effects. Sometimes they are serious,

most of the time they are not. You

may need medical attention if you

get some of the side effects.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

The following side effects are the

more common side effects of

DULOXECOR

often

mild

and short-lived.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

dry mouth, mouth ulcers, thirst,

bad taste

burping or belching, indigestion,

stomach pain, nausea, vomiting,

constipation, diarrhoea, wind

(flatulence)

bad breath

loss of appetite, weight loss

headache

trouble sleeping

dream abnormalities

drowsiness

feeling tired or having no energy

sexual problems

dizziness

tremor

blurred vision

feeling anxious, agitated or

restless

confusion and attention problems

tingling and numbness of hands,

face, mouth and feet

yawning or throat tightness

difficulty urinating (passing

water), urinating frequently or

needing to urinate at night.

irregular heart beat

hot and cold sweats

sore ears, sore throat

ringing in ears

muscle pain, stiffness or

twitching

walking problems

flushing

skin rash

restless legs

These are the more common side

effects of your medicine.

Tell your doctor immediately if

you notice any of the following:

signs of a possible serious liver

problem,

such as nausea, vomiting, loss of

appetite, feeling generally unwell,

fever, itching, yellowing of the

skin and/or eyes, dark urine

high pressure in the eye

(glaucoma)

feeling tired, weak or confused

and having achy, stiff or

uncoordinated muscles. This may

be because you have low sodium

levels in the blood (hyponatraemia

or syndrome of inappropriate

antidiuretic hormone)

abdominal pain, traces of blood in

your stools, or if your stools are

dark in colour. This may because

you have increased bleeding,

possibly in the gastric tract

(gastrointestinal bleeding). You

may also feel weakness, dizziness

and experience nausea and/or

vomiting

seeing or hearing things

(hallucinations)

dizziness or fainting when you

stand up, especially from a lying

or sitting position

uncontrollable movements

if you have some or all of the

following symptoms you may

have something called serotonin

syndrome: feeling confused,

feeling restless, sweating,

shaking, shivering, hallucinations,

sudden jerks in your muscles or a

fast heart beat

stiff neck or jaw muscles

(lockjaw)

fits or seizures

mood of excitement, over-activity

and uninhibited behaviour.

aggression or anger especially

after starting or stopping taking

this medicine

need

urgent

medical

attention.

Other changes you may not be aware

increased blood pressure

heart rhythm changes

underactive thyroid gland

liver function changes

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

itching, skin rash or hives

shortness of breath, wheezing or

trouble breathing

swelling of the face, lips, tongue

or other parts of the body

These are very serious side effects.

You may need urgent medical

attention or hospitalisation.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

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.

After taking

DULOXECOR

Storage

Keep your capsules in the pack

until it is time to take them.

If you take the capsules out of the

pack they may not keep as well.

Keep your capsules in a cool dry

place where the temperature stays

below 25°C.

Do not store DULOXECOR or

any

other

medicine

in

the

bathroom or near a sink. Do not

leave it on a window sill or in the

car.

Duloxecor CMI 5

Heat and dampness 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 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

DULOXECOR 30 mg capsules

have an opaque blue color cap and

opaque white color body, imprinted

“Dulox” on cap with white ink and

“30 mg” on body with

black ink and are available in packs

of 28 capsules in blister.

DULOXECOR 60 mg capsules

have an opaque blue color cap and

opaque green color body, imprinted

“Dulox” on cap with

white ink and

“60mg” on body with white ink and

are available in packs of 28 capsules

in blister.

Ingredients

Active Ingredients

30 mg capsule - duloxetine

hydrochloride equivalent to

duloxetine 30 mg

60 mg capsule - duloxetine

hydrochloride equivalent to

duloxetine 60 mg

Inactive Ingredients

sugar spheres

hypromellose

hydroxypropylcellulose

crospovidone

talc-purified

triethyl citrate

titanium dioxide

hypromellose phthalate

gelatin

sodium lauryl sulphate

indigo carmine

TEK SW 0012 –white ink (ARTG

No.13175)

TEK SW 9008 –black ink (ARTG

No.2328) (30 mg capsule)

iron

oxide yellow (60 mg capsule).

This medicine does not contain

lactose, gluten, tartrazine or any

other azo dyes.

Name and Address of Sponsor

PHARMACOR PTY LIMITED

Suite 501, 7 oaks Avenue

Dee Why NSW 2099

Australia

Australian Registration

Number:

30 mg capsules: 209155

60 mg capsules: 209161

Date of most recent amendment

08/09/2016

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Europe -DG Health and Food Safety

23-1-2019


Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Europe - EMA - European Medicines Agency

22-1-2019


Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

16-1-2019

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Active substance: Benserazide hydrochloride) - Orphan designation - Commission Decision (2019)221 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001719

Europe -DG Health and Food Safety

16-1-2019

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (Active substance: Doxorubicin hydrochloride (in heat-sensitive liposomes)) - Transfer of orphan designation - Commission Decision (2019)237 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003113

Europe -DG Health and Food Safety

16-1-2019

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Active substance: 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride) - Transfer of orphan designation - Commission Decision (2019)236 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003283

Europe -DG Health and Food Safety

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

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

7-8-2018

Duloxetine Mylan (Generics [UK] Limited)

Duloxetine Mylan (Generics [UK] Limited)

Duloxetine Mylan (Active substance: Duloxetine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5417 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3981/T/14

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

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

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

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

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

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

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

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

Europe -DG Health and Food Safety

5-7-2018

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

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

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

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

29-6-2018

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

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

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

Europe -DG Health and Food Safety