VENLA

Main information

  • Trade name:
  • VENLA RBX venlafaxine (as hydrochloride) 150 mg modified release capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VENLA RBX venlafaxine (as hydrochloride) 150 mg modified release capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210375
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210375

VENLA RBX venlafaxine (as hydrochloride) 150 mg modified release capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Sun Pharma ANZ Pty Ltd

Postal Address

Suite 2 02 Level 2 12 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

26/08/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. VENLA RBX venlafaxine (as hydrochloride) 150 mg modified release capsule blister pack

Product Type

Single Medicine Product

Effective date

24/08/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

VENLA RBX is indicated for the treatment of: - Major depression, including prevention of relapse and recurrence where appropriate; - Generalised

anxiety disorder; - Social anxiety disorder; Panic disorder, including prevention of relapse.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PCTFE (Aclar)/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Blister Pack

PVC/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

28 capsules

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. VENLA RBX venlafaxine (as hydrochloride) 150 mg modified release capsule blister pack

Dosage Form

Capsule, modified release

Route of Administration

Oral

Visual Identification

Dark orange / dark orange size 0 hard capsule with thick and thin radial

circular band on the body and cap in white ink.

Active Ingredients

Venlafaxine hydrochloride

169.8 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 09:53:55 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

VENLA RBX CMI V5 Aug 2013

Page 1 of 13

VENLA RBX

Venlafaxine Modified Release Capsules

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about VENLA RBX

(venlafaxine

hydrochloride) modified release capsules.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

This leaflet was last updated on the date at the end of this leaflet.

More recent information may be available. The latest Consumer Medicine

Information is available from

https://www.ebs.tga.gov.au/ and may

contain important information about the medicine and its use of which

you should be aware.

All medicines have risks and benefits. Your doctor has weighed the

risks of you taking VENLA RBX against the benefits it is expected to

have for you.

If you have any concerns about using/taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with this medicine.

You may need to read it again.

What VENLA RBX is used for

VENLA

contains

active

ingredient

venlafaxine

hydrochloride).

VENLA RBX is used for the treatment and prevention of relapse of

depression, and for the treatment of panic attacks and anxiety,

including avoidance or fear of social situations.

Depression can affect your whole body and may cause emotional and

physical symptoms such as feeling low in spirit, being unable to enjoy

life, poor appetite or overeating, disturbed sleep, loss of sex drive,

lack of energy and feeling guilty over nothing.

Excessive anxiety is a condition in which you feel constantly and

uncontrollably worried and distressed. It may also make you feel

irritable, and cause difficulty in thinking and sleeping. Other common

symptoms associated with anxiety may include a dry mouth, a lump in the

throat, cold clammy hands, diarrhoea and nausea.

VENLA RBX CMI V5 Aug 2013

Page 2 of 13

Depression and anxiety are treatable illnesses. Anxiety or tension

associated with the normal stress of everyday life usually does not

require treatment with medicines.

VENLA RBX

is not addictive.

Your doctor may have prescribed VENLA RBX

capsules for another purpose.

Ask your doctor if you have any questions about why VENLA RBX has been

prescribed for you.

How does VENLA RBX work?

VENLA RBX belongs to a class of medications for depression and anxiety

called Serotonin-Noradrenaline Reuptake Inhibitors (SNRIs).

Serotonin and noradrenaline are chemical messengers that allow certain

nerves in the brain to work. VENLA RBX increases the level of these two

messengers. Experts think this is how it helps to restore your feeling

of wellness.

It is available only with a doctor’s prescription.

Before you take VENLA RBX

When you must not take it

Do not take VENLA RBX if you are taking other medications for

depression known as monoamine oxidase inhibitors, even if you have

stopped taking them now, but have taken them within the last 14 days.

Do not take VENLA RBX if you are allergic to it or to any of the

ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction include:

Rash, itching or hives on the skin

Swelling of the face, lips, tongue, throat or other parts of the

body

Shortness of breath, wheezing or troubled breathing; difficulty

swallowing

Do not give VENLA RBX to children or adolescents under 18 years of age.

The safety and effectiveness of VENLA RBX in this age group have not

been established.

Do not use VENLA RBX after the expiry date (EXP) printed on the pack.

If you take this medicine after the expiry date has passed, it may not

work as well as it should.

VENLA RBX CMI V5 Aug 2013

Page 3 of 13

Do not use VENLA RBX if the packaging is torn or shows signs of

tampering.

If you are not sure whether you should start taking this medicine, talk

to your doctor.

Before you start to take VENLA RBX

Tell your doctor or pharmacist if you have allergies to the active

ingredient or any of the other ingredients listed at the end of this

leaflet.

Tell your doctor or pharmacist if you are pregnant or intend to become

pregnant.

VENLA RBX is not recommended for use during pregnancy. Your doctor will

discuss the risks and benefits of using VENLA RBX if you are pregnant.

One of these risks is that newborn babies whose mothers have been

taking VENLA RBX in the last few months of pregnancy, may experience

problems

soon

after

delivery,

including

breathing

difficulties,

seizures and lack of oxygen in their blood.

Tell your doctor or pharmacist if you are breast-feeding or planning to

breast-feed.

Venlafaxine passes into breast milk and there is a possibility that the

breast-fed baby may be affected. For this reason, the use of VENLA RBX

is not recommended in breast-feeding women.

Tell your doctor if you have, or have had, any medical conditions,

especially the following:

• A history of fits (seizures or convulsions)

• A personal history or family history of bipolar disorder

• A history of aggression

• Blood pressure problems

• Glaucoma (increased pressure in the eye)

• A tendency to bleed more than normal

• Raised cholesterol levels

• Problems with your kidneys or liver

• Problems with your heart

Your

doctor

wish

some

heart

tests

such

electrocardiogram (ECG) or blood tests during treatment with VENLA RBX.

Tell your doctor if you plan to have surgery.

If you have not told your doctor about any of the above, tell them

before you take VENLA RBX.

Taking other medicines

VENLA RBX CMI V5 Aug 2013

Page 4 of 13

Tell your doctor or pharmacist if you take any other medicines,

including all prescription medicines, all medicines, vitamins, herbal

supplements or natural therapies you buy without a prescription from a

pharmacy, supermarket, naturopath or health food shop.

Do not start to take any other medicine while you are taking VENLA RBX,

unless it is prescribed or approved by your doctor.

Some medicines may interfere with VENLA RBX or VENLA RBX may interfere

with these medicines. These include:

Medications for depression known as monoamine oxidase inhibitors

(such as moclobemide, linezolid, phenelzine and tranylcypromine),

even if you have stopped taking them now, but have taken them

within the last 14 days. Your doctor or pharmacist can tell you

what to do if you are taking any of these medicines

other

medications

depression,

anxiety,

obsessive-

compulsive disorder or premenstrual dysphoric disorder, including

St John's Wort

Haloperidol, risperidone, lithium or clozapine (used to treat

mental disorders)

Tramadol,

fentanyl,

tapentadol,

pethidine,

methadone

pentazocine (pain killers)

Cimetidine (used to treat reflux and stomach ulcers)

Triptans (used to treat migraine)

Amiodarone or quinidine (used to treat irregular heart beats)

Your

doctor

wish

some

heart

tests

such

electrocardiogram (ECG) or blood tests if you are using any of these

medicines whilst taking VENLA RBX:

Indinavir (an antiviral)

Medicines used to prevent blood clotting such as anti-coagulants

and platelet inhibitors

Erythromycin and linezolid (used to treat infections)

Ketoconazole or fluconazole (used as antifungal medicines)

Medications for weight loss, including sibutramine

Metoprolol (used to treat high blood pressure or angina)

You may need to use different amounts of your medicine, or you may need

to take different medicines. Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to be

careful with or to avoid while taking VENLA RBX.

How to take VENLA RBX

Follow all directions given to you by your doctor or pharmacist

carefully.

They may differ from the information contained in this leaflet.

VENLA RBX CMI V5 Aug 2013

Page 5 of 13

If you do not understand the instructions on the box, ask your doctor

or pharmacist for help.

How much to take

Your doctor will tell you how many capsules you need to take each day.

This may depend on your age, your condition and whether or not you are

taking any other medicines.

Depression and Anxiety

The usual starting dose is 75 mg taken once daily. If necessary, after

two weeks, your doctor may increase your dose.

Panic attacks

The usual starting dose is 37.5 mg taken once daily for the first 4 to

7 days, then increased to 75 mg taken once daily.

Do not change your dose unless your doctor tells you to.

If you have kidney or liver problems, you may need a lower dose of

VENLA RBX. If you have heart problems and your doctor wishes to

increase your dose of VENLA RBX, your doctor may first do some blood

tests or heart tests such as an electrocardiogram (ECG).

How to take it

Swallow the capsules whole with a glass of water or other non-alcoholic

liquid. Do not divide, crush, chew or place the capsules in water.

Inside VENLA RBX capsules are spheroids or small white balls that

contain the venlafaxine active ingredient. These spheroids are released

from the capsule into your gastrointestinal tract. As the spheroids

travel the length of your gastrointestinal tract, venlafaxine is slowly

released.

When to take it

VENLA RBX should be taken once daily with food at approximately the

same time each day.

This could be either in the morning or in the evening. Taking it at the

same time each day will have the best effect. It will also help you to

remember when to take it.

Avoid drinking alcohol while you are using VENLA RBX.

How long to take VENLA RBX

Continue taking your medicine for as long as your doctor tells you.

VENLA RBX CMI V5 Aug 2013

Page 6 of 13

Although you may begin to feel better after two weeks, it may take

several weeks before you feel much better. It is important to give

VENLA RBX time to work.

Even when you feel well again, you may need to keep taking VENLA RBX

for several months to make sure the benefits last. Discuss this with

your doctor and don't stop taking VENLA RBX until gaining your doctor's

agreement.

If you forget to take VENLA RBX

If it is less than 12 hours until your next dose, skip the dose you

missed and then take your next dose when you are meant to. Otherwise,

take it as soon as you remember, and then go back to taking as you

would normally.

Do not take a double dose to make up for the dose you missed.

This may increase the chance of you getting an unwanted side effect.

Contact your doctor if you have missed more than two doses in a row.

Always finish the capsules you are taking in the current pack before

you start a new pack.

If you have trouble remembering when to take your medicine, ask your

pharmacist for some hints.

If you take too much (overdose)

It is important that you do not take more VENLA RBX capsules than your

doctor has prescribed. If you do take more than you have been

prescribed, contact your doctor immediately for advice.

If anyone accidentally swallows any VENLA RBX capsules, call your

nearest Poisons Information Centre (tel. 131126) for advice, or go to

Accident and Emergency at your nearest hospital

Do this even if there

are no signs of discomfort or poisoning.

Keep the telephone number for

these places handy whilst taking any medications.

If you take too many VENLA RBX capsules you may:

feel sleepy

vomit

have an increased heart rate or changes in heart rhythm

have a seizure (fits)

have breathing difficulties

become unconscious

have dilated pupils

While you are using VENLA RBX

VENLA RBX CMI V5 Aug 2013

Page 7 of 13

Things you must do

Visit your doctor regularly for a check up so that your progress can be

checked. Always discuss any questions you have about VENLA RBX with

your doctor.

Your doctor may do some tests (such as an electrocardiogram (ECG) or

blood tests) from time to time to make sure the medicine is working and

to prevent unwanted side effects.

If you are going to have surgery, tell your doctor that you are taking

this medicine.

Some agents used to assist your doctor during surgery may interact with

VENLA RBX leading to unwanted side effects.

If you are about to have any urine tests, tell your doctor that you are

taking this medicine.

It may interfere with the results of some tests.

Take VENLA RBX as your doctor has prescribed.

Keep enough VENLA RBX capsules to last weekends and holidays.

This

medicine helps to control your condition, but does not cure it. It is

important to keep taking your medicine even if you feel well. You need

a prescription from your doctor to get more VENLA RBX capsules.

Tell any other doctors, dentists and pharmacists who treat you that you

are taking this medicine.

Watch carefully for signs that your depression is getting worse,

especially in the first few weeks of treatment, or if your dose has

changed.

Sometimes people with depression can experience a worsening of their

depressive

symptoms.

This

happen

even

when

taking

antidepressant.

Information

from

clinical

trials

suggested

that

children,

adolescents and young adults (18-24 years), particularly those with

depression, may be at increased risk of suicidal behaviour (including

suicide attempts) during treatment with venlafaxine, especially during

initial treatment.

Tell your doctor immediately if you experience any of the following

symptoms, especially if they are severe, you have not had these

symptoms before or they happen very suddenly.

Anxiety or agitation

Panic attacks

Difficulty sleeping

VENLA RBX CMI V5 Aug 2013

Page 8 of 13

Irritability

Aggressiveness

Hostility or impulsiveness

Restlessness

Overactivity or uninhibited behaviour

Other usual changes in behaviour

Thoughts of suicide

Tell your doctor immediately if you have any thoughts about suicide or

doing harm to yourself.

Warning signs of suicide:

All thoughts or talk about suicide or violence are serious.

If you or

someone you know is showing the following warning signs, either contact

your doctor or a mental health advisor right away or go to the nearest

hospital for treatment:

• Thoughts or talk about death or suicide

• Thoughts or talk about self-harm or doing harm to others

• Any recent attempts of self-harm

• An increase in aggressive behaviour, irritability or agitation

Things to be careful of

VENLA RBX may make you feel drowsy.

Be careful driving or operating

dangerous machinery until you know how it affects you.

If you are feeling drowsy or are uncoordinated, be careful that you do

not fall over.

VENLA RBX, like other medicines in this class, may increase your risk

of bone fracture.

Things you must not do

Do not suddenly stop taking VENLA RBX if you have been taking it for

some time.

Check with your doctor for the best way to slowly reduce the amount of

VENLA RBX you are taking before stopping completely.

Side effects from stopping treatment suddenly with VENLA RBX may

include:

Headache

Nausea and vomiting

Dizziness

Insomnia

Nervousness

Anxiety

VENLA RBX CMI V5 Aug 2013

Page 9 of 13

Confusion and agitation

Diarrhoea

Sweating

Loss of appetite

Tremor

Flu-like symptoms

Impaired coordination and balance

Tingling or numbness of the hands and feet

Slowly reducing the amount of VENLA RBX being taken reduces the

possibility of these effects occurring.

Some of these symptoms may impair driving, or the operation of

dangerous machinery. These activities should be avoided if you

experience these symptoms.

Do not give this medicine to anyone else even if they have the same

condition as you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel

well while you are taking VENLA RBX.

All medicines can have side effects. Sometimes they are serious; often

they are not. You may need medical attention if you get some of the

side effects.

It can be difficult to tell whether side effects are the result of

taking this medicine, effects of your condition, or side effects of

other medicines you may be taking. For this reason it is important to

tell your doctor of any change in your condition.

Do not be alarmed by the list of side effects.You may not experience

any of them.

Ask your doctor or pharmacist any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and

they worry you:

Stomach, bowel or urinary tract problems such as:

Nausea or vomiting

Loss of appetite

Diarrhoea

Constipation

Difficulty passing urine, passing urine more frequently, or

urinary incontinence

Changes in your behaviour such as:

VENLA RBX CMI V5 Aug 2013

Page 10 of 13

Difficulty sleeping or abnormal dreams

Paranoia

Sexual function problems such as delayed ejaculation, problems

with erection, decreased sex drive or difficulties achieving

orgasm

Nervousness

Teeth grinding

Impaired coordination and balance

Difficulty thinking or working because of:

• Yawning

• Feeling sedated or drowsy

• Fainting or dizziness after standing up

• Restlessness or difficulty sitting still

• Headache

• Rapid heart beat

• Problems with breathing

• Heavy or irregular menstrual periods

Changes in your appearance such as:

• Sweating

• Hot flushes

• Rash

• Hair loss

• Itchiness

• Weight loss or weight gain

• Flow of milk in women who are not breast-feeding

In some people, VENLA RBX may lead to changes in the way your blood

clots.

Changes in your sight, hearing, taste or touch such as:

Blurred vision

Ringing in the ears

Altered taste

Dry mouth

Tell your doctor immediately if you notice any of the following:

Muscle tremors, spasms, twitching, jerky movements or sustained

muscle contractions

Abnormal facial movements such as tongue thrusting, repetitive

chewing, jaw swinging, or grimacing

A feeling of apathy or not caring about things

Hallucinations

Agitation

Confusion

VENLA RBX CMI V5 Aug 2013

Page 11 of 13

Unusually overactive

Changes in muscle tone, muscle weakness or fatigue

Numbness or pins and needles

Problems with breathing, shortness of breath

Bleeding or bruising more easily than normal

Sensitivity to sunlight

Tell your doctor immediately, or go to Accident and Emergency at your

nearest hospital if you notice any of the following:

Fits or seizures, which may be accompanied by a sudden fever

Signs of allergy such as rash or hives, swelling of the face,

lips or tongue, wheezing or difficulty breathing or swallowing

Symptoms of sudden fever with sweating, rapid heart beat and

muscle stiffness, which may lead to loss of consciousness

Palpitations, fainting, shortness of breath or chest pain

Dark, red or cola coloured urine, muscle weakness and tenderness,

stiffness or aching

Stomach pain, yellowing of the skin, nausea, fever, clammy skin

and sweating

Yellowing of the skin or eyeballs, fever, fatigue, loss of

appetite, dark coloured urine or light coloured bowel movements

A severe skin reaction with painful red areas and large blisters,

accompanied by fever and chills, aching muscles and generally

feeling unwell

Symptoms of a high fever, agitation, confusion, trembling and

abrupt contractions of muscles

Signs of an infection such as severe chills, fever, sore throat

and mouth ulcers.

Black sticky bowel motions or bloody diarrhoea

These symptoms are usually rare but may be serious and need urgent

medical attention.

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.

Other side effects not listed above may also occur in some patients.

Some of these side effects (for example, increase in blood pressure or

blood cholesterol) can only be found when your doctor does tests from

time to time to check your progress.

Tell your doctor if you notice anything else that is making you feel

unwell, even if it is not on this list.

After using it

Storage

VENLA RBX CMI V5 Aug 2013

Page 12 of 13

Keep your VENLA RBX capsules in their blister pack until it is time to

take them.

The capsules may not last as well if you take them out of the blister

pack.

Keep VENLA RBX in a cool dry place where the temperature stays below 25

degrees C.

Do not store VENLA RBX or any other medicine in the bathroom or near a

sink. Do not leave VENLA RBX capsules in the car or on windowsills.

Heat and dampness can destroy some medicines.

Keep VENLA RBX where young 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

Return any unused medicine to your pharmacist.

Product description

What it looks like

VENLA RBX

75 and 150 mg capsules are available in blister packs of 28

capsules.

VENLA RBX 75 mg capsules are peach cap and body with thick and thin

radial circular bands on the cap and body in red ink.

VENLA RBX 150 mg capsules are dark orange cap and body with thick and

thin radial circular bands on the cap and body in white ink.

Ingredients

Active ingredient

VENLA

capsule

contains

venlafaxine

hydrochloride)

VENLA

capsule

contains

venlafaxine

hydrochloride)

Inactive ingredients

microcrystalline cellulose

povidone

purified talc

VENLA RBX CMI V5 Aug 2013

Page 13 of 13

colloidal anhydrous silica

magnesium stearate

ethylcellulose

copovidone

gelatin

titanium dioxide

iron oxide black, iron oxide red and TekPrint SB-1033 Red Ink

(proprietary ingredient # 106948)(75 mg capsule only)

Brilliant Blue FCF, Allura Red AC, Sunset Yellow FCF and TekPrint

SB-0007P White Ink (proprietary ingredient # 2216) (150 mg capsule

only)

VENLA RBX capsules do not contain gluten, lactose or sucrose.

Australian Registration Nos.

VENLA RBX

75 mg capsules: AUST R 210374

VENLA RBX

150 mg capsules: AUST R 210375

Sponsor

VENLA RBX

capsules are supplied in Australia by:

Ranbaxy Australia Pty. Ltd.

9-13 Waterloo Road

Macquarie Park NSW 2113

Australia

This leaflet was prepared in August 2013.

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Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

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

Europe -DG Health and Food Safety

5-7-2018

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

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

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

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

29-6-2018

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

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

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

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Active substance: canagliflozin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)3463 of Wed, 30 May 2018

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Active substance: Ponatinib hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3141 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/212/14/T/02

Europe -DG Health and Food Safety

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety

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