PIP-METOPROLOL

Main information

  • Trade name:
  • PIP-METOPROLOL metoprolol tartrate 50 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PIP-METOPROLOL metoprolol tartrate 50 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222119
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222119

PIP-METOPROLOL metoprolol tartrate 50 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Ipca Pharma (Australia) Pty Ltd

Postal Address

6 Morotai Avenue,ASHBURTON, VIC, 3147

Australia

ARTG Start Date

25/03/2015

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. PIP-METOPROLOL metoprolol tartrate 50 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

29/10/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Hypertension: as monotherapy or for use in combination with other antihypertensives.,Angina pectoris: for long-term prophylaxis. Glyceryl trinitrate

should be employed if necessary for alleviating acute attacks.,Confirmed or suspected myocardial infarction.,Prevention of migraine.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

36 Months

Store below 30

degrees Celsius

Not recorded

Protect from Moisture

Protect from Light

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. PIP-METOPROLOL metoprolol tartrate 50 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Pink, round, biconvex film-coated tablets with 'B' & 'L' separated by notch

break line on one side and '50' debossed on other side.

Active Ingredients

Metoprolol tartrate

50 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 12:07:05 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

PIP-Metoprolol Tartrate Tablets 50 mg & 100 mg CMI v1.1

PIP-Metoprolol Tartrate Tablets 50 mg & 100 mg

Metoprolol tartrate

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some of the

common questions people ask

about PIP-Metoprolol Tartrate

Tablets. It does not contain all the

information that is known about

PIP-Metoprolol Tartrate Tablets.

It does not take the place of talking

to your doctor and pharmacist.

All medicines have risks and

benefits. Your doctor will have

weighed the risks of you taking this

medicine against the benefits they

expect it will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the

medicine. You may need to read it

again.

WHAT PIP-Metoprolol Tartrate

Tablets IS FOR

PIP-Metoprolol Tartrate Tablets is

used:

1. to lower high blood pressure,

also called hypertension

2. to prevent a type of chest pain,

also called angina

3. after a heart attack

4. to prevent migraine headaches.

Hypertension

Everyone has blood pressure. This

pressure helps to move your blood

around your body. Your blood

pressure may be different at

various times of the day,

depending on how busy you are.

You have hypertension (high blood

pressure) when your blood

pressure stays higher than is

needed, even when you are calm

and relaxed. If high blood pressure

is not treated it can lead to serious

health problems, including stroke,

heart disease and kidney failure.

There are usually no symptoms of

hypertension. The only way of

knowing that you have it is to have

your blood pressure checked on a

regular basis. You may feel fine

and have no symptoms but, if high

blood pressure is not treated, it

can lead to serious health

problems. PIP-Metoprolol Tartrate

Tablets helps to lower your blood

pressure.

Angina

Angina is a pain or uncomfortable

feeling in the chest, often

spreading to the arms or neck and

sometimes to the shoulders and

back. This may be caused by too

little blood and oxygen getting to

the heart. The pain of angina is

usually brought on by exercise or

stress but it can also happen while

you are resting.

PIP-Metoprolol Tartrate Tablets

helps to prevent angina from

happening. It is not used to treat a

sudden attack.

Reducing heart complications

after heart attack

After a heart attack there is a

chance of developing

complications such as an irregular

heart beat (also called an

arrhythmia) or another heart

attack.

PIP-Metoprolol Tartrate Tablets

helps to prevent these conditions

from happening.

Migraine

This is a throbbing headache,

usually affecting one side of the

head and often accompanied by

nausea, vomiting and sensitivity to

light.

PIP-Metoprolol Tartrate Tablets

belongs to a group of medicines

called beta-blockers. It works by

affecting the body's response to

some nerve impulses, especially in

the heart. As a result, it decreases

the heart's need for blood and

oxygen and reduces the amount of

work that the heart has to do. It

also widens the blood vessels in

the rest of the body.

PIP-Metoprolol Tartrate Tablets

can be used alone or in

combination with other medicines

to treat your condition.

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.

PIP-Metoprolol Tartrate Tablets is

not recommended for use in

children.

PIP-Metoprolol Tartrate Tablets is

only available with a doctor's

prescription.

It is not addictive.

BEFORE YOU TAKE PIP-

Metoprolol Tartrate Tablets

When you must not take it

Do not take PIP-Metoprolol

Tartrate Tablets if you have an

allergy to:

metoprolol (the active

ingredient) or to any of the

other ingredients of PIP-

Metoprolol Tartrate Tablets

listed at the end of this leaflet

any other beta-blocker

medicines.

Some of the symptoms of an

allergic reaction may include:

rash

itching or hives on the skin

swelling of the face, lips,

tongue or other parts of the

body

shortness of breath, wheezing

or troubled breathing.

Do not take PIP-Metoprolol

Tartrate Tablets if you have any

of the following medical

conditions:

PIP-Metoprolol Tartrate Tablets 50 mg & 100 mg CMI v1.1

sudden loss of consciousness

sometimes

asthma, wheezing, difficulty

breathing or other severe lung

problems, or you have had

these problems in the past

a history of allergic problems,

including hay fever

a very slow heart beat, less

than 45 to 50 beats per minute

low blood pressure

a severe blood vessel disorder

causing poor circulation in the

arms and legs

a severe drop in blood

pressure, dizziness, fast heart

beat, rapid and shallow

breathing, cold clammy skin

phaeochromocytoma (a rare

tumour of the adrenal gland)

which is not already being

treated with other medicines

sudden and oppressive chest

pain, sign of heart attack

irregular heart beat

swollen ankles and/or tiredness

due to heart disease or certain

other heart conditions.

heart disorders

poor blood circulation in your

limbs(for example, very cold,

pale hands or feet, or pain in

your leg muscles when you

walk).

Undergo an operation where an

anesthetis is used during

treatment with respiratory

diseases such as asthma.

Oculomucocutaneous

syndrome(signs include severe

conjunctivitis and skin rash and

ear infection)

If you are not sure whether any

of the above medical conditions

apply to you, check with your

doctor.

Do not take PIP-Metoprolol

Tartrate Tablets after the expiry

date printed on the pack or if the

packaging is torn or shows

signs of tampering.

In that case, return it to your

pharmacist.

Do not give this medicine to a

child.

There is not enough information on

its use in children.

Before you start to take it

Tell your doctor if you are

allergic to:

any other medicines, foods,

dyes or preservatives

bee or wasp stings

Your doctor will want to know if

you are prone to allergies. Beta-

blocker medicines can make an

allergic reaction worse.

Tell your doctor if you have any

of the following medical

conditions:

diabetes

an overactive thyroid gland

kidney problems

liver problems

chest pain when you are at rest,

or certain types of angina, such

as Prinzmetal angina or variant

angina

Your doctor may want to take

special precautions if you have any

of the above conditions.

Tell your doctor if you are

pregnant or intend to become

pregnant.

PIP-Metoprolol Tartrate Tablets

should not be used throughout

pregnancy, especially during the

first 3 months of pregnancy, unless

clearly necessary.

PIP-Metoprolol Tartrate Tablets

may affect your baby, especially if

you take it in the last few days

before your baby is born.

Your doctor can discuss the risks

and benefits of taking this

medicine during pregnancy.

Tell your doctor if you are

breast-feeding or intend to

breast-feed.

The active ingredient in PIP-

Metoprolol Tartrate Tablets passes

into breast milk and there is a

possibility that your baby could be

affected.

If you have not told your doctor

about any of these things, tell

him/her before you take PIP-

Metoprolol Tartrate Tablets.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

medicines that you buy without

a prescription from a pharmacy,

supermarket or health food

shop.

Other medicines and PIP-

Metoprolol Tartrate Tablets may

interfere with each other. These

medicines include:

other beta-blocker medicines

other medicines used to treat

high blood pressure such as

calcium channel blockers and

clonidine

some medicines used to treat

angina

adrenaline or similar

substances, which are often

found in eye or nose drops, or

in some cough and cold

medicines

other medicines used to treat

irregular heart beat

(arrhythmi

medicines for diabetes

quanethidine, a medicine used

to treat certain heart conditions

some local and general

anaesthetics used during

surgery

monoamine-oxidase inhibitor

(MAOI) medicines

warfarin, a medicine used to

prevent blood clots

non-steroidal anti-inflammatory

drugs such as COX-2

inhibitorsto relieve pain or

inflammation.

indomethacin, a medicine for

arthritis, pain or inflammation

cimetidine, a medicine for

stomach ulcers

some antibiotics (e.g.

rifampicin)

some antivirals (e.g. ritonavir)

some antihistamines (e.g.

diphenhydramine)

some antidressant medications

(e.g. fluoxetine, paroxetine or

bupropion)

some antifungals (e.g.

terbinafine)

ergot alkaloids, a class of

medicines used in the

prevention and treatment of

migraine headaches.

Dipyridamole, a medicine used

to reduce the risk of blood clots

PIP-Metoprolol Tartrate Tablets 50 mg & 100 mg CMI v1.1

You may need to take 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 PIP-Metoprolol Tartrate

Tablets.

HOW TO TAKE IT

Follow the directions given to

you by your doctor and

pharmacist carefully.

These directions may differ from

the information contained in this

leaflet.

If you do not understand the

instructions on the label, ask

your doctor or pharmacist for

help.

How much to take

High blood pressure:

The usual dose is from 50 mg to

200 mg each day, either as a

single dose or divided into two

doses.

Angina:

The usual dose is from 100 mg to

300 mg each day, divided into two

or three doses.

After a heart attack:

The usual dose is 200 mg each

day, divided into two doses.

To prevent migraine:

The usual dose is from 100 mg to

150 mg each day, divided into two

doses (morning and evening).

How to take it

Swallow the tablets whole with a

full glass of water or other

liquid.

It does not matter if you take PIP-

Metoprolol Tartrate Tablets before

or after food.

How long to take it

Continue taking PIP-Metoprolol

Tartrate Tablets for as long as

your doctor tells you to.

PIP-Metoprolol Tartrate Tablets

helps to control your symptoms but

it does not cure your condition.

Your doctor will check your

progress to make sure the

medicine is working and will decide

how long your treatment should

continue.

Talk to your doctor if you are

not sure how long you need to

take your medicine for.

If you forget to take it

If it is almost time for your next

dose (eg. within 2 or 3 hours),

skip the dose you missed and

take your next dose when you

are meant to.

Otherwise, take the dose as

soon as you remember, and

then go back to taking it as you

would normally.

Do not take a double dose to

make up for the one that you

missed.

This may increase the chance of

you getting an unwanted side

effect.

If you have trouble remembering

when to take your medicine, ask

your pharmacist for some hints.

If you take too much

Immediately telephone your

doctor or Poisons Information

Centre (telephone 13 11 26) for

advice, or go to Accident and

Emergency at your nearest

hospital if you think that you or

anyone else may have taken too

much PIP-Metoprolol Tartrate

Tablets. Do this even if there are

no signs of discomfort or

poisoning.

Keep the telephone numbers for

these places handy.

Symptoms of an overdose may

include feeling sick and vomiting,

bluish skin and nails, very low

blood pressure, slow heart beat,

difficulty breathing, fainting,

convulsions (fits) or coma.

WHILE YOU ARE TAKING PIP-

Metoprolol Tartrate Tablets

Things you must do

Be sure to keep all of your

doctor's appointments so that

your progress can be checked.

This helps your doctor to give you

the best treatment and to prevent

unwanted side effects from

happening.

If you become pregnant while

taking PIP-Metoprolol Tartrate

Tablets, tell your doctor.

Your doctor can discuss with you

the risks and benefits of taking it

while you are pregnant.

If you have an allergic reaction

to a food, another medicine or

an insect sting while you are

taking PIP-Metoprolol Tartrate

Tablets, tell your doctor

immediately.

There is a chance that PIP-

Metoprolol Tartrate Tablets could

make the allergic reaction worse or

harder to treat.

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

You may feel light-headed or dizzy

when you start to take PIP-

Metoprolol Tartrate Tablets.

This is because your blood

pressure is falling suddenly. If this

problem doesn't go away, talk to

your doctor.

To avoid symptoms of low blood

pressure, here are some hints that

may help:

Stand up slowly to help your

body get used to the change in

position and blood pressure

If you feel dizzy, sit or lie down

until you feel better

If you feel faint, breathe deeply

and bend forward with your

head between your knees

PIP-Metoprolol Tartrate Tablets 50 mg & 100 mg CMI v1.1

Take extra care when

exercising, driving or standing

for long periods, especially in

hot weather. Drink plenty of

fluids, especially if you sweat a

lot.

If you are being treated for

diabetes, make sure you check

your blood sugar regularly and

report any problems to your

doctor.

PIP-Metoprolol Tartrate Tablets

may change how well your

diabetes is controlled. It may also

prevent some of the warning signs

of low blood sugar, such as fast

heart beat, and may make low

blood sugar last longer. The dose

of your diabetes medicines may

need to be changed.

If you plan to have surgery and

will need an anaesthetic, tell

your doctor or dentist that you

are taking PIP-Metoprolol

Tartrate Tablets.

This will help your doctor to

prevent unwanted side effects

such as a sudden drop in blood

pressure.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking PIP-Metoprolol

Tartrate Tablets.

Tell any other doctor, dentist or

pharmacist who treats you that

you are taking PIP-Metoprolol

Tartrate Tablets.

Things you must not do

Do not stop taking PIP-

Metoprolol Tartrate Tablets

without telling your doctor first.

Your doctor may want to gradually

reduce the amount of PIP-

Metoprolol Tartrate Tablets you

are taking before stopping it

completely. This helps to reduce

the chance of your condition

becoming worse or keep other

unwanted heart problems from

happening.

Do not use PIP-Metoprolol

Tartrate Tablets to treat any

other complaints unless your

doctor says you can.

Do not give this medicine to

anyone else, even if their

symptoms seem to be similar to

yours.

Things to be careful of

Be careful driving, operating

machinery or doing jobs that

require you to be alert while you

are taking PIP-Metoprolol

Tartrate Tablets until you know

how it affects you.

As with other beta-blocker

medicines, PIP-Metoprolol Tartrate

Tablets may cause dizziness, light-

headedness or decreased

alertness in some people.

If you have any of these

symptoms, do not drive or do

anything else that could be

dangerous.

Be careful to dress warmly

during cold weather, especially

if you will be outside for a long

time.

Like other beta-blocker medicines,

PIP-Metoprolol Tartrate Tablets

may make you more sensitive to

cold temperatures, especially if

you have problems with your blood

circulation. These medicines tend

to decrease blood circulation in the

skin, fingers and toes.

SIDE EFFECTS

Tell your doctor or pharmacist

as soon as possible if you do

not feel well while you are taking

PIP-Metoprolol Tartrate Tablets.

All medicines have side effects.

Sometimes they are serious, most

of the time they are not. You may

need medical treatment if you get

some of the side effects. If you are

over 65 years of age, you may

have an increased chance of

getting side effects.

Do not be alarmed by this list of

possible side effects. You may

not experience any of them.

Ask your doctor or pharmacist

to answer any questions you

may have.

Tell your doctor if you notice

any of the following side effects

and they worry you:

tiredness, drowsiness,

decreased alertness

dizziness, spinning sensation

(vertigo), light-headedness or

fainting

headache or other aches and

pains

difficulty sleeping, nightmares

depression or other changes in

mood

confusion or loss of memory

stomach ache or upset, nausea

(feeling sick) or vomiting

diarrhoea or constipation

dry or irritated eyes, blurred

vision

buzzing or ringing in the ears,

or other difficulty hearing

dry mouth

increased sweating

runny or blocked nose

problems with sexual function

numbness, tingling in the

extremities

weight gain

hair thinning

worsening of psoriasis

muscle cramps or painful joints

a tingling sensation

abnormal triglycerides or

cholesterol values, or liver

function tests during treatment

with PIP-Metoprolol Tartrate

Tablets

sleepiness during the day or

troubled sleep

diarrhoea or constipation

Tell your doctor immediately or

go to Accident and Emergency

at your nearest hospital if you

notice any of the following:

signs of allergy such as

swelling of the face, lips or

tongue which may cause

problems with swallowing or

breathing

chest tightness, wheezing, rattly

breathing

shortness of breath, sometimes

with tiredness, weakness or

reduced ability to exercise

swelling of the feet or legs due

to fluid build-up

PIP-Metoprolol Tartrate Tablets 50 mg & 100 mg CMI v1.1

coldness, burning, numbness or

pain in arms and legs

chest pain

pain behind the breastbone

(different from angina)

changes in heart rate (fast,

slow, irregular)

yellowing of the skin or eyes

(jaundice), sometimes with pain

in the abdomen

constant "flu-like" symptoms

(chills, fever, sore throat, aching

joints, swollen glands, tiredness

or lack of energy)

unusual bleeding or bruising

skin reactions (rash, itching,

worsening of psoriasis)

symptoms of sunburn (redness,

itching, swelling, blistering) that

happen much more quickly than

normal

abnormal thinking or

hallucinations (seeing or

hearing things that are not

there)

breathelessness, difficulty

breathing when lying down,

swelling of the feet or legs,

signs of heart disorders.

The above side effects could be

serious. You may need urgent

medical attention.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Other side effects not listed above

may happen in some people.

AFTER TAKING PIP-Metoprolol

Tartrate Tablets

Storage

Keep your tablets in the original

container until it is time to take

them.

Store the tablets in a cool dry

place.

Do not store PIP-Metoprolol

Tartrate Tablets or any other

medicine in the bathroom or

near a sink.

Do not leave the tablets in the

car or on window sills.

Heat and dampness can destroy

some medicines. PIP-Metoprolol

Tartrate Tablets will keep well if it

is cool and dry.

Keep this medicine 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 PIP-Metoprolol Tartrate

Tablets or the expiry date on the

medicine has passed, ask your

pharmacist what to do with any

tablets that are left over.

PRODUCT DESCRIPTION

What PIP-Metoprolol Tartrate

Tablets looks like

PIP-Metoprolol Tartrate Tablets 50

mg tablets are pink, round,

biconvex film-coated tablets with

‘B’ and ‘L” separated by a notch

break line on one side and ‘50’

embossed on the other side; one

carton contains 100 tablets or 10

tablets.

PIP-Metoprolol Tartrate Tablets

100 mg tablets are white to off

white, round, biconvex film-coated

tablets with ‘B’ and ‘L” separated

by a notch break line on one side

and ‘100’ embossed on the other

side; one carton contains 60

tablets or 10 tablets.

Ingredients:

PIP-Metoprolol Tartrate Tablets

contains 50 mg or 100 mg of

metoprolol tartrate as the active

ingredient.

The tablets also contain the

following in-active ingredients:

Lactose

Cellulose- microcrystalline

Sodium starch glycollate

Silica - colloidal anhydrous

Croscarmellose sodium

Starch pregelatinozed - maize

Talc - purified

Magnesium stearate

Hypromellose

Macrogol 400

Titanium dioxide

Iron oxide – red (50 mg only)

NAME AND ADDRESS OF THE

SPONSOR

www.ipca.com.

IPCA PHARMA (AUSTRALIA)

PTY. LTD

6 Morotai Avenue

Ashburton VIC 3147

AUSTRALIA

This leaflet was prepared in

January 2015

Australian Registration Numbers:

50mg

AUST R 222119

100mg AUST R 222120

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

26-7-2018

Opinion/decision on a Paediatric investigation plan (PIP):    Ninlaro, Ixazomib, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro, Ixazomib, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

25-7-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Enfortumab vedotin, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Enfortumab vedotin, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

25-7-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Ponesimod, Therapeutic area: Neurology

Opinion/decision on a Paediatric investigation plan (PIP): -, Ponesimod, Therapeutic area: Neurology

Europe - EFSA - European Food Safety Authority EFSA Journal

25-7-2018

Opinion/decision on a Paediatric investigation plan (PIP):    Spinraza, Nusinersen, Therapeutic area: Neurology

Opinion/decision on a Paediatric investigation plan (PIP): Spinraza, Nusinersen, Therapeutic area: Neurology

Europe - EFSA - European Food Safety Authority EFSA Journal

24-7-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Palovarotene, Therapeutic area: Other

Opinion/decision on a Paediatric investigation plan (PIP): -, Palovarotene, Therapeutic area: Other

Europe - EFSA - European Food Safety Authority EFSA Journal

24-7-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Andexanet alfa, Therapeutic area: Other

Opinion/decision on a Paediatric investigation plan (PIP): -, Andexanet alfa, Therapeutic area: Other

Europe - EFSA - European Food Safety Authority EFSA Journal

24-7-2018

Opinion/decision on a Paediatric investigation plan (PIP):    Penthrox, Methoxyflurane, Therapeutic area: Pain

Opinion/decision on a Paediatric investigation plan (PIP): Penthrox, Methoxyflurane, Therapeutic area: Pain

Europe - EFSA - European Food Safety Authority EFSA Journal

19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Pevonedistat, Therapeutic area: Oncology

Opinion/decision on a Paediatric investigation plan (PIP): -, Pevonedistat, Therapeutic area: Oncology

Europe - EFSA - European Food Safety Authority EFSA Journal

2-10-2018

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Active substance: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone) - Transfer of orphan designation - Commission Decision (2018)6436 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/163/13/T/01

Europe -DG Health and Food Safety

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

28-8-2018

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

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

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

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

1-8-2018

Champix (Pfizer Europe MA EEIG)

Champix (Pfizer Europe MA EEIG)

Champix (Active substance: varenicline tartrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5197 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/699/T/71

Europe -DG Health and Food Safety

27-7-2018

EU/3/04/192 (Celgene Europe B.V.)

EU/3/04/192 (Celgene Europe B.V.)

EU/3/04/192 (Active substance: 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione) - Transfer of orphan designation - Commission Decision (2018)5040 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/083/03/T/02

Europe -DG Health and Food Safety

25-7-2018

Respiporc Flu3 (IDT Biologika GmbH)

Respiporc Flu3 (IDT Biologika GmbH)

Respiporc Flu3 (Active substance: Inactivated vaccine against swine influenza in pigs) - Centralised - Yearly update - Commission Decision (2018)4991 of Wed, 25 Jul 2018

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (PharmaKrysto Ltd)

EU/3/18/2036 (Active substance: L-cystine bis(N'-methylpiperazide)) - Orphan designation - Commission Decision (2018)4181 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/012/18

Europe -DG Health and Food Safety

27-6-2018

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Active substance: (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3,4-dihydro-4-quinazolinyl} acetic acid) - Transfer of orphan designation - Commission Decision (2018)4102 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/10/T/02

Europe -DG Health and Food Safety