Pharm-Olanzapine

Main information

  • Trade name:
  • Pharm-Olanzapine olanzapine 7.5mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pharm-Olanzapine olanzapine 7.5mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207845
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207845

Pharm-Olanzapine olanzapine 7.5mg film-coated tablet 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

12/12/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

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

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

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

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

Products

1. Pharm-Olanzapine olanzapine 7.5mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

9/03/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Olanzapine is indicated for the treatment of schizophrenia and related psychoses.,Olanzapine alone or in combination with lithium or valproate is

indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.,Olanzapine is indicated for preventing recurrence of

manic, mixed or depressive episodes in Bipolar I Disorder.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

28's blister pack (2 x 14 or 4x7's tablets)

(S4) Prescription Only Medicine

Components

1. Pharm-Olanzapine olanzapine 7.5mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White to off white colored, film coated, round shaped, biconvex tablets,

imprinted '7.5' with black ink on one side and plain on the other side.

Active Ingredients

Olanzapine

7.5 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 11:57:55 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Pharm-Olanzapine

PHARM-OLANZAPINE

olanzapine

Consumer Medicine Information

What is in this leaflet

This

leaflet

designed

provide

you with answers to some common

questions about this medicine. It does

contain

available

information

does

take

place of talking with your doctor.

The information in this leaflet was

last updated on the date shown on the

final page. More recent information

about this medicine may be available.

Make

sure

speak

your

pharmacist

doctor

obtain

most up to date information on this

medicine.

All medicines have risks and

benefits.

Your

doctor

more

information

about this medicine than is contained

in this leaflet. Also, your doctor has

had the benefit of taking a full and

detailed history from you and is in

the best position to make an expert

judgement to meet your individual

needs.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with this

medicine.

You may need to read it again.

What Pharm-

Olanzapine is used for

Pharm-Olanzapine

belongs

group

medicines

called

antipsychotics.

helps

correct

chemical

imbalances

brain,

which may cause mental illness.

Pharm-Olanzapine

used

treat

symptoms

schizophrenia

related psychoses. Schizophrenia is a

mental

illness

with

disturbances

thinking, feelings and behaviour.

Pharm-Olanzapine

alone,

combination

with

lithium

valproate, is used for the short-term

treatment

acute

manic

episodes

associated with Bipolar I Disorder.

Pharm-Olanzapine

also

mood

stabiliser

that

prevents

further

occurrences

disabling

high

(depressed)

extremes

mood

associated

with

Bipolar

Disorder.

Bipolar I Disorder is a mental illness

with

symptoms

such

feeling

"high", having excessive amounts of

energy, needing much less sleep than

usual,

talking

very

quickly

with

racing

ideas

sometimes

severe

irritability.

Your doctor may have prescribed

Pharm-Olanzapine

another

reason.

Ask your doctor if you have any

questions

about

why

Pharm-

Olanzapine has been prescribed

for you.

This medicine is available only with

a doctor's prescription.

Pharm-Olanzapine

recommended

children

under the age of 18 years as there is

enough

information

effects in this age group.

Before taking

Pharm-Olanzapine

Tell your doctor if you have any of

the following conditions or if you

have ever experienced any of these

conditions.

When you must not take it

Do not take Pharm-Olanzapine:

if

you

have

had

an

allergic

reaction to any type of Pharm-

Olanzapine or to any of the

ingredients listed at the end of

this

leaflet

(see

'Product

Description').

Signs of an allergic reaction may

include

skin

rash,

itching,

shortness of breath or swelling of

the face, lips or tongue.

if the packaging is torn or

shows signs of tampering or the

tablets

or

wafers

do

not

look

quite right.

if the expiry date on the pack

has passed.

If you take this medicine after the

expiry date has passed it may not

work as well.

If you are not sure whether you

should

start

taking

Pharm-

Olanzapine, talk to your doctor or

pharmacist.

Before you start to take it

Tell your doctor if you have had an

allergic

reaction

to

any

medicine

which you have taken previously to

treat your current condition.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

Pharm-Olanzapine

tumour of the pituitary gland (a

small gland at the base of the

brain)

disease

blood

with

reduced number of white or red

blood cells

disease of the blood vessels of the

brain, including stroke

prostate problems

kidney or liver disease

high blood sugar, diabetes or a

family history of diabetes

breast cancer or a family history

of breast cancer

paralytic ileus, a condition where

the small bowel does not work

properly

epilepsy (seizures or fits)

glaucoma, a condition in which

there is usually a build up of fluid

in the eye

heart disease, including irregular

heart rhythm

neuroleptic malignant syndrome,

a reaction to some medicines with

sudden

increase

body

temperature, extremely high

blood pressure and severe

convulsions

tardive dyskinesia, a reaction to

some

medicines

with

uncontrollable

twitching

jerking movements of the arms

and legs.

Tell your doctor if you are pregnant

or intend to become pregnant.

Like

most

antipsychotic

medicines,

Pharm-Olanzapine is not recommended

for use during pregnancy. If there is a

need

consider

Pharm-Olanzapine

during your pregnancy, your doctor will

discuss with you the benefits and risks

of using it.

Tell your doctor if you are breast-

feeding or plan to breast-feed.

It is recommended that you do not

breast-feed

while

taking

Pharm-

Olanzapine.

Tell your doctor if you suffer from

lactose

intolerance

(because

Pharm-Olanzapine tablets contain

lactose).

Tell your doctor if you will be in a

hot

environment

or

do

a

lot

of

vigorous exercise.

Pharm-Olanzapine

make

sweat

less,

causing

your

body

overheat.

Tell your doctor if you smoke.

Smoking

affect

Pharm-

Olanzapine or may affect how it

works.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines may be affected by

Pharm-Olanzapine

affect

how it works. These include:

medicines used to treat a fast or

irregular heart beat (arrhythmia)

medicines taken for anxiety or to

help you sleep

medicines taken for depression

carbamazepine, a medicine used

for mood stabilisation and to treat

epilepsy

other centrally acting medicines

(eg. tranquillisers)

ciprofloxacin, a medicine used to

treat bacterial infections

medicines that lower blood

pressure

medicines used for Parkinson's

disease

medicines

that

change

heart's electrical activity or make

it more likely to change.

Your doctor or pharmacist has more

information

medicines

careful with or avoid while taking

Pharm-Olanzapine.

Tell your doctor about these things

before

you

take

Pharm-

Olanzapine.

How to take Pharm-

Olanzapine

Follow all directions given to you

by

your

doctor

or

pharmacist

carefully.

These

differ

from

information

contained

this

leaflet.

How much to take

Pharm-Olanzapine tablets:

Your doctor will tell you how many

Pharm-Olanzapine

tablets

should take. The dose your doctor

will prescribe for you will usually

be in the range 5 mg to 20 mg per

day.

Your

doctor

increase

decrease your dose in order to find

appropriate

dose

your

condition.

lower

starting

dose

prescribed for elderly patients over

the age of 65 years.

How to take it

Pharm-Olanzapine

tablets

should

be swallowed whole with a glass

of water.

When to take it

Pharm-Olanzapine

tablets

should be taken once a day as

advised by your doctor.

Take your prescribed dose at the

same time each day.

Pharm-Olanzapine

tablets

taken with or without food.

How long do I take it

Do

not

stop

taking

Pharm-

Olanzapine just because you feel

better. It is important that you

do

NOT

stop

taking

Pharm-

Olanzapine

unless

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.

Pharm-Olanzapine

Otherwise,

take

soon

remember then go back to taking your

medicine as you would normally.

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 take too much

Immediately telephone your doctor

or

the

Australian

Poisons

Information Centre (telephone 13

11 26) or the New Zealand

National Poisons Centre (0800

POISON or 0800 764 766), or go to

Accident and Emergency at your

nearest hospital, if you think that

you or anyone else has taken too

much Pharm-Olanzapine. Do this

even

if

there

are

no

signs

of

discomfort or poisoning.

If you have taken too much Pharm-

Olanzapine,

most

common

signs are fast heart beat, agitation/

aggression,

difficulty

speaking,

uncontrollable

movements

sedation.

While you are taking

Pharm-Olanzapine

Things you must do

It is important that you remember

to

take

Pharm-Olanzapine

daily

and at the dose prescribed by your

doctor.

Tell

all

doctors,

dentists

and

pharmacists who are treating you

that

you

are

taking

Pharm-

Olanzapine.

While

you

are

taking

Pharm-

Olanzapine,

tell

your

doctor

or

pharmacist before you start any

new medicine.

If

you

become

pregnant

while

taking

Pharm-Olanzapine,

tell

your doctor.

Keep

all

of

your

doctor's

appointments

so

that

your

progress can be checked.

Your doctor should monitor your

weight while you are taking

Pharm-Olanzapine.

Patients

with

diabetes

have

higher

chance

developing diabetes should have

their blood sugar checked often.

If you are over 65, your doctor

measure

your

blood

pressure from time to time.

Tell your doctor if you are female

and

your

monthly

periods

are

absent for six months or more.

Talk

to

your

doctor

or

mental

health

professional

if

you

have

thoughts or talk about death or

suicide; or thoughts or talk about

self-harm

or

doing

harm

to

others.

These may be signs of changes or

worsening in your mental illness.

Things you must not do

Do

not

stop

taking

Pharm-

Olanzapine, or lower the dosage,

even

if

you

are

feeling

better,

without

checking

with

your

doctor.

Do not give Pharm-Olanzapine to

anyone

else,

even

if

their

symptoms

seem

similar

or

they

have the same condition as you.

Your doctor has prescribed Pharm-

Olanzapine

your

condition.

Things to be careful of

Be

careful

driving

or

operating

machinery

until

you

know

how

Pharm-Olanzapine affects you.

Pharm-Olanzapine

cause

drowsiness in some people.

Be careful when drinking alcohol

while taking Pharm-Olanzapine.

The effects of alcohol could be made

worse

while

taking

Pharm-

Olanzapine.

Your doctor may suggest you avoid

alcohol while you are being treated

with Pharm-Olanzapine.

If

Pharm-Olanzapine

makes

you

feel light- headed, dizzy or faint, be

careful

when

getting

up

from

a

sitting or lying position.

Getting up slowly may help.

If

outdoors,

wear

protective

clothing

and

use

at

least

a

30+

sunscreen.

Pharm-Olanzapine may cause your

skin to be much more sensitive to

sunlight than it is normally.

Exposure to sunlight may cause a

skin rash, itching, redness, or severe

sunburn.

If

your

skin

does

appear

to

be

burning, tell your doctor.

Make sure you keep cool in hot

weather and keep warm in cool

weather.

Pharm-Olanzapine

affect

way your body reacts to temperature

changes

Side effects

medicines

have

some

unwanted

side

effects.

Sometimes

they are serious, but most of the time

they

not.

Your

doctor

weighed

risks

using

this

medicine against

the benefits they

expect it will have for you.

Like

other

medicines,

Pharm-

Olanzapine

cause

some

unwanted

side

effects.

These

likely to vary from patient to patient.

Some side effects may be related to

dose

Pharm-Olanzapine.

Accordingly, it is important that you

tell your doctor as soon as possible

about

unwanted

effects.

Your

doctor may then decide to adjust the

dose of Pharm-Olanzapine you are

taking.

Tell your doctor if you notice any

of the following side effects and

they worry you:

drowsiness

unusual tiredness or weakness

fever

restlessness or difficulty sitting

still

increased appetite, weight gain

constipation, bloating

dry mouth

swelling of your hands, feet and

ankles

Pharm-Olanzapine

aching joints

nose bleeds

dizziness, confusion, forgetfulness

Some people may feel dizzy in the

early stages of treatment, especially

when

getting

from

lying

sitting

position.

This

side

effect

usually passes after taking Pharm-

Olanzapine for a few days.

Tell your doctor if you notice any

of the above side effects and they

worry you.

These

more

common

side

effects of Pharm-Olanzapine.

Tell

your

doctor

as

soon

as

possible if you notice any of the

following side effects:

symptoms of sunburn (such as

redness,

itching,

swelling

blistering

skin)

which

occur more quickly than normal

rash or allergic reaction

slow heart beat

changes in sexual functioning or

sex drive in men or women

prolonged

and/or

painful

erection

unusual secretion of breast milk

breast

enlargement

women

symptoms of high sugar levels in

blood

(including

passing

large

amounts

urine,

excessive

thirst,

having

mouth and skin and weakness).

These may indicate the onset or

worsening of diabetes

reaction

following

abrupt

discontinuation

(profuse

sweating, nausea or vomiting)

absence of menstrual periods and

changes

regularity

menstrual periods

involuntary passing of urine or

difficulty in initiating urination

unusual hair loss or thinning.

These

side

effects

uncommon

but may require medical attention.

Tell your doctor immediately or

go to Accident and Emergency at

your nearest hospital if you notice

any of the following:

Sudden

signs

allergic

reaction

such

skin

rash,

itching,

shortness

breath

swelling

face,

lips

tongue.

frequent infections such as fever,

severe

chills,

sore

throat

mouth ulcers

bleeding or bruising more easily

than normal

seizures, fits or convulsions

yellowing

skin

and/or

eyes

nausea,

vomiting,

loss

appetite,

generally

feeling

unwell, fever, itching, yellowing

of the skin and/or eyes

severe upper stomach pain often

with

nausea

vomiting

(inflammation of the pancreas)

worm-like

movements

tongue,

other

uncontrolled

movements

tongue,

mouth,

cheeks,

which

may progress to the arms and

legs

sudden

increase

body

temperature, sweating, fast heart

beat,

muscle

stiffness,

high

blood pressure and convulsions

sharp

chest

pain,

coughing

blood,

sudden

shortness

breath

pain/tenderness

calf

muscle area

muscle

pain,

muscle

weakness

and brown urine

heart palpitations and dizziness,

which may lead to collapse.

These are very serious side effects.

need

urgent

medical

attention or hospitalisation.

All of these side effects are very

rare.

The following additional side

effects may occur in some groups of

people taking Pharm-Olanzapine:

Elderly patients with

dementia-related psychosis

Elderly patients with dementia-

related psychosis may notice the

following side effects:

unusual manner of walking

falls

pneumonia

involuntary passing of urine.

Parkinson's disease

psychosis

Some

patients

with

Parkinson's

disease may hallucinate (see, feel or

hear

things

that

there)

develop

worsening

symptoms

Parkinson's disease.

Pharm-Olanzapine

in

combination with lithium or

valproate

Patients

with

bipolar

mania

taking

Pharm-Olanzapine

combination

with lithium or valproate may notice

the following additional side effects:

tremors

speech disorder.

Tell

your

doctor

if

you

notice

anything

unusual

or

if

you

are

concerned about any aspect of your

health,

even

if

you

think

the

problems

are

not

connected

with

this medicine and are not referred

to in this leaflet.

Also,

some

side

effects,

such

changes to liver function, cholesterol

or triglycerides can occur. These can

only be found when your doctor does

tests from time to time to check your

progress.

Do not be alarmed by this list of side

effects.

You may not experience any of them.

Other

side

effects

listed

above

may also occur in some patients.

Tell

your

doctor

if

you

notice

anything else that is making you feel

unwell.

Pharm-Olanzapine

After

taking

Pharm-

Olanzapine

Storage

Keep

your

tablets

in

the

blister

pack until it is time to take them.

Keep your tablets in a cool, dry

place where the temperature stays

below 25°C.

Do not store Pharm-Olanzapine in

the bathroom or near a sink.

Do not leave your tablets in the

car on hot days or on window sills.

Heat

dampness

destroy

some medicines.

All

medicines

should

be

kept

where

young

children

cannot

reach them.

A locked cupboard at least one and

a half metres above the ground is a

good place to store medicines.

There will be an expiry date (month,

year)

your

Pharm-Olanzapine

container.

The medicine should not be taken

after this date because it may have

lost some of its strength.

Disposal

your

doctor

tells

stop

taking

Pharm-Olanzapine

find that the tablets have passed their

expiry date, please return any left

over tablets to your pharmacist.

Product Description

What it looks like

Pharm-Olanzapine

tablets

White to off white colored, film

coated, round shaped, biconvex

tablets, imprinted “2.5” with black

ink on one side and plain on the

other side.

Pharm-Olanzapine

tablets

White to off white colored, film

coated, round shaped, biconvex

tablets, imprinted “5” with black ink

on one side and plain on the other

side

Pharm-Olanzapine tablets 7.5 mg:

White to off white colored, film

coated,

round

shaped,

biconvex

tablets, imprinted “7.5” with black

ink on one side and plain on the

other side.

Pharm-Olanzapine tablets 10 mg:

White to off white colored, film

coated,

round

shaped,

biconvex

tablets, imprinted “10” with black

ink on one side and plain on the

other side.

Pharm-Olanzapine tablets come in

blister packs in the following pack

sizes:

Pharm-Olanzapine

tablets– 28 tablets;

Pharm-Olanzapine

tablets–

tablets

tablets;

Pharm-Olanzapine

tablets– 28 tablets;

Pharm-Olanzapine

tablets–

tablets

tablets;

Ingredients

Pharm-Olanzapine

tablets:

Active Ingredient:

tablet

olanzapine per tablet

5 mg tablet - 5 mg

olanzapine per tablet

tablet

olanzapine per tablet

tablet

olanzapine per tablet

Inactive Ingredient:

lactose, hydroxypropylcellulose,

mannitol, magnesium stearate,

pectin, glycerol triacetate, titanium

dioxide, talc-purified, isopropyl

alcohol and Opacode S-1-17823

black (ARTG # 12108).

Supplier

PHARMACOR PTY LIMITED

Suite 401, 7 Oaks Avenue

Dee Why NSW 2099

Australia

Australian Registration

Numbers

Pharm-Olanzapine tablets:

2.5 mg tablet - AUST R 207844

5 mg tablet - AUST R 207860

7.5 mg tablet - AUST R 207845

10 mg tablet - AUST R 207848

This leaflet was prepared in December

2014.

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4-3-2019

Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement

Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement

Weston, Florida, Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany.

FDA - U.S. Food and Drug Administration

1-3-2019

Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP

Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

1-3-2019

New EU report on big data paves the way for action

New EU report on big data paves the way for action

A taskforce on big data in the pharmaceutical area, the HMA-EMA Joint Big Data Taskforce, has just published its first report. The report offers a definition of big data and several recommendations for European authorities that regulate medicines and medical devices.

Danish Medicines Agency

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

12-2-2019

February 7, 2019: Three Federal Cases Allege Illegal Importation and Sale of ‘Herbal’ Sexual Enhancement Pills that Contained Pharmaceutical Drugs

February 7, 2019: Three Federal Cases Allege Illegal Importation and Sale of ‘Herbal’ Sexual Enhancement Pills that Contained Pharmaceutical Drugs

February 7, 2019: Three Federal Cases Allege Illegal Importation and Sale of ‘Herbal’ Sexual Enhancement Pills that Contained Pharmaceutical Drugs

FDA - U.S. Food and Drug Administration

8-2-2019

New data analysis centre to open at the Danish Medicines Agency

New data analysis centre to open at the Danish Medicines Agency

The Danish government today announced its decision to support the establishment of a new data analysis centre in the Danish Medicines Agency. The centre is to handle the analysis of large data quantities in the pharmaceutical and medical devices areas and will set new standards for the monitoring of the safety and efficacy of medicines and medical devices after their marketing.

Danish Medicines Agency

31-1-2019

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States

FDA - U.S. Food and Drug Administration

22-1-2019

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

18-1-2019

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products

-- Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.

FDA - U.S. Food and Drug Administration

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

6-1-2019

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

FDA - U.S. Food and Drug Administration

3-1-2019

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

FDA - U.S. Food and Drug Administration

20-12-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinog...

FDA - U.S. Food and Drug Administration

18-12-2018


Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Europe - EMA - European Medicines Agency

15-3-2019

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

EU/3/15/1597 (Active substance: Sodium (2R,3S,5R)-5-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-2-(hydroxymethyl)tetrahydrofuran-3-yl ((2R,3S,5R)-5-(2-amino-6-oxo-1H-purin-9(6H)-yl)-3-hydroxytetrahydrofuran-2-yl)methyl phosphate) - Transfer of orphan designation - Commission Decision (2019)2107 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004914

Europe -DG Health and Food Safety

13-3-2019

Slenyto (RAD Neurim Pharmaceuticals EEC SARL)

Slenyto (RAD Neurim Pharmaceuticals EEC SARL)

Slenyto (Active substance: melatonin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2064 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425/T/04

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1281 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/14/1281 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/14/1281 (Active substance: 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide) - Transfer of orphan designation - Commission Decision (2019)1953 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004132

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/563 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/563 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/563 (Active substance: Recombinant derivative of C3 transferase) - Transfer of orphan designation - Commission Decision (2019)1952 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004115

Europe -DG Health and Food Safety

7-3-2019

EU/3/18/2091 (S-cubed Pharmaceutical Services ApS)

EU/3/18/2091 (S-cubed Pharmaceutical Services ApS)

EU/3/18/2091 (Active substance: Glucagon) - Transfer of orphan designation - Commission Decision (2019)1740 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004177

Europe -DG Health and Food Safety

27-2-2019

Zavicefta (Pfizer Ireland Pharmaceuticals)

Zavicefta (Pfizer Ireland Pharmaceuticals)

Zavicefta (Active substance: ceftazidime/avibactam) - Centralised - Yearly update - Commission Decision (2019)1673 of Wed, 27 Feb 2019

Europe -DG Health and Food Safety

27-2-2019

Zypadhera (Eli Lilly Nederland B.V.)

Zypadhera (Eli Lilly Nederland B.V.)

Zypadhera (Active substance: Olanzapine) - Centralised - Yearly update - Commission Decision (2019)1674 of Wed, 27 Feb 2019

Europe -DG Health and Food Safety

27-2-2019

Hetlioz (Vanda Pharmaceuticals Germany GmbH)

Hetlioz (Vanda Pharmaceuticals Germany GmbH)

Hetlioz (Active substance: tasimelteon) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1668 of Wed, 27 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3870/T/13

Europe -DG Health and Food Safety

25-2-2019

EU/3/05/301 (Taro Pharmaceuticals Europe B.V.)

EU/3/05/301 (Taro Pharmaceuticals Europe B.V.)

EU/3/05/301 (Active substance: Chimeric monoclonal antibody to shiga-toxin 1 and 2) - Transfer of orphan designation - Commission Decision (2019)1636 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003835

Europe -DG Health and Food Safety

25-2-2019

Consultation: Proposed criteria for Appendix M of the Poisons Standard to support rescheduling of substances from Schedule 4 (Prescription only) to Schedule 3 (Pharmacist only)

Consultation: Proposed criteria for Appendix M of the Poisons Standard to support rescheduling of substances from Schedule 4 (Prescription only) to Schedule 3 (Pharmacist only)

The TGA is seeking comments from interested parties on the proposed criteria, accompanying guidance and plans for monitoring of the supply of Schedule 3 (S3) Pharmacist only - Appendix M substances. Closing date: 1 April 2019

Therapeutic Goods Administration - Australia

22-2-2019

Bortezomib SUN (Sun Pharmaceutical Industries Europe BV)

Bortezomib SUN (Sun Pharmaceutical Industries Europe BV)

Bortezomib SUN (Active substance: bortezomib) - PSUSA - Modification - Commission Decision (2019)1586 of Fri, 22 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4076/PSUSA/424/201804

Europe -DG Health and Food Safety

20-2-2019

Zyprexa (Eli Lilly Nederland B.V.)

Zyprexa (Eli Lilly Nederland B.V.)

Zyprexa (Active substance: Olanzapine) - Centralised - Yearly update - Commission Decision (2019)1515 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

19-2-2019

Besremi (AOP Orphan Pharmaceuticals AG)

Besremi (AOP Orphan Pharmaceuticals AG)

Besremi (Active substance: ropeginterferon alfa-2b) - Centralised - Authorisation - Commission Decision (2019)1455 of Tue, 19 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4128/00

Europe -DG Health and Food Safety

18-2-2019

EU/3/18/2116 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/18/2116 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/18/2116 (Active substance: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor) - Transfer of orphan designation - Commission Decision (2019)1362 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003732

Europe -DG Health and Food Safety

15-2-2019

Circadin (RAD Neurim Pharmaceuticals EEC SARL)

Circadin (RAD Neurim Pharmaceuticals EEC SARL)

Circadin (Active substance: Melatonin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1079 of Fri, 15 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/695/T/58

Europe -DG Health and Food Safety

15-2-2019


HMA/EMA Joint Task Force on big data – Survey for pharmaceutical industry

HMA/EMA Joint Task Force on big data – Survey for pharmaceutical industry

HMA/EMA Joint Task Force on big data – Survey for pharmaceutical industry

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/18/2117 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/18/2117 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/18/2117 (Active substance: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor) - Transfer of orphan designation - Commission Decision (2019)1363 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003788

Europe -DG Health and Food Safety

11-2-2019

Raxone (Santhera Pharmaceuticals (Deutschland) GmbH)

Raxone (Santhera Pharmaceuticals (Deutschland) GmbH)

Raxone (Active substance: idebenone) - Centralised - Yearly update - Commission Decision (2019)1074 of Mon, 11 Feb 2019

Europe -DG Health and Food Safety

8-2-2019

Zyprexa Velotab (Eli Lilly Nederland B.V.)

Zyprexa Velotab (Eli Lilly Nederland B.V.)

Zyprexa Velotab (Active substance: Olanzapine) - Centralised - Yearly update - Commission Decision (2019)1038 of Fri, 08 Feb 2019

Europe -DG Health and Food Safety

4-2-2019

On January 28th, @US_FDA  identified a Class I Recall, the most serious  type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid  Transfer Systems Due to Potential Malfunctions. Find out more about the recall here:  https://go.usa.gov/xEX

On January 28th, @US_FDA identified a Class I Recall, the most serious type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions. Find out more about the recall here: https://go.usa.gov/xEX

On January 28th, @US_FDA identified a Class I Recall, the most serious type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions. Find out more about the recall here: https://go.usa.gov/xEXHM  #FDA #MedicalDevice pic.twitter.com/0l5O1bSaUy

FDA - U.S. Food and Drug Administration

4-2-2019

Resolor (Shire Pharmaceuticals Ireland Limited)

Resolor (Shire Pharmaceuticals Ireland Limited)

Resolor (Active substance: prucalopride) - Centralised - Yearly update - Commission Decision (2019)840 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

4-2-2019

Olanzapine Glenmark (Glenmark Arzneimittel GmbH)

Olanzapine Glenmark (Glenmark Arzneimittel GmbH)

Olanzapine Glenmark (Active substance: Olanzapine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)853 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/1085/T/29

Europe -DG Health and Food Safety

4-2-2019

Olanzapine Glenmark Europe (Glenmark Arzneimittel GmbH)

Olanzapine Glenmark Europe (Glenmark Arzneimittel GmbH)

Olanzapine Glenmark Europe (Active substance: Olanzapine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)856 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/1086/T/27

Europe -DG Health and Food Safety

25-1-2019

Revestive (Shire Pharmaceuticals Ireland Limited)

Revestive (Shire Pharmaceuticals Ireland Limited)

Revestive (Active substance: teduglutide) - Centralised - Yearly update - Commission Decision (2019)681 of Fri, 25 Jan 2019

Europe -DG Health and Food Safety

23-1-2019

EU/3/15/1490 (S-cubed Pharmaceutical Services ApS)

EU/3/15/1490 (S-cubed Pharmaceutical Services ApS)

EU/3/15/1490 (Active substance: Triamcinolone acetonide) - Transfer of orphan designation - Commission Decision (2019)579 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003126

Europe -DG Health and Food Safety

23-1-2019

EU/3/14/1342 (S-cubed Pharmaceutical Services ApS)

EU/3/14/1342 (S-cubed Pharmaceutical Services ApS)

EU/3/14/1342 (Active substance: Glucagon) - Transfer of orphan designation - Commission Decision (2019)578 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003128

Europe -DG Health and Food Safety

23-1-2019

EU/3/13/1204 (S-cubed Pharmaceutical Services ApS)

EU/3/13/1204 (S-cubed Pharmaceutical Services ApS)

EU/3/13/1204 (Active substance: Sirolimus) - Transfer of orphan designation - Commission Decision (2019)577 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003156

Europe -DG Health and Food Safety

23-1-2019

EU/3/11/872 (S-cubed Pharmaceutical Services ApS)

EU/3/11/872 (S-cubed Pharmaceutical Services ApS)

EU/3/11/872 (Active substance: Sulfonated monophosphorylated mannose oligosaccharide) - Transfer of orphan designation - Commission Decision (2019)576 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003129

Europe -DG Health and Food Safety

22-1-2019

Lumigan (Allergan Pharmaceuticals Ireland)

Lumigan (Allergan Pharmaceuticals Ireland)

Lumigan (Active substance: Bimatoprost) - PASS - Modification - Commission Decision (2019)586 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/413/201803

Europe -DG Health and Food Safety

22-1-2019

EU/3/10/841 (Vanda Pharmaceuticals Germany GmbH)

EU/3/10/841 (Vanda Pharmaceuticals Germany GmbH)

EU/3/10/841 (Active substance: Tasimelteon) - Transfer of orphan designation - Commission Decision (2019)573 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002557

Europe -DG Health and Food Safety

18-1-2019


Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Europe - EMA - European Medicines Agency

17-1-2019

Natpar (Shire Pharmaceuticals Ireland Limited)

Natpar (Shire Pharmaceuticals Ireland Limited)

Natpar (Active substance: parathyroid hormone) - PSUSA - Modification - Commission Decision (2019)269 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10591/201804

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2130 (Arena Pharmaceuticals Limited)

EU/3/18/2130 (Arena Pharmaceuticals Limited)

EU/3/18/2130 (Active substance: Ralinepag) - Orphan designation - Commission Decision (2019)239 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002037

Europe -DG Health and Food Safety

15-1-2019

Symkevi (Vertex Pharmaceuticals (Ireland) Limited)

Symkevi (Vertex Pharmaceuticals (Ireland) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)188 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004682/T/0003

Europe -DG Health and Food Safety

20-12-2018


Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities

Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities

Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities

Europe - EMA - European Medicines Agency

20-12-2018

Ledaga (Helsinn Birex Pharmaceuticals Ltd.)

Ledaga (Helsinn Birex Pharmaceuticals Ltd.)

Ledaga (Active substance: chlormethine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)9124 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2826/T/8

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Active substance: Sodium 2-hydroxylinoleate) - Orphan designation - Commission Decision (2018)9036 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2117 (Vertex Pharmaceuticals (Europe) Limited)

EU/3/18/2117 (Vertex Pharmaceuticals (Europe) Limited)

EU/3/18/2117 (Active substance: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor) - Orphan designation - Commission Decision (2018)9032 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/137/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2116 (Vertex Pharmaceuticals (Europe) Limited)

EU/3/18/2116 (Vertex Pharmaceuticals (Europe) Limited)

EU/3/18/2116 (Active substance: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor) - Orphan designation - Commission Decision (2018)9031 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/139/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2115 (Yes Pharmaceutical Development Services GmbH)

EU/3/18/2115 (Yes Pharmaceutical Development Services GmbH)

EU/3/18/2115 (Active substance: Human anti-promyostatin monoclonal antibody) - Orphan designation - Commission Decision (2018)9030 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/136/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2114 (Shire Pharmaceuticals Ireland Limited)

EU/3/18/2114 (Shire Pharmaceuticals Ireland Limited)

EU/3/18/2114 (Active substance: C1 esterase inhibitor (human)) - Orphan designation - Commission Decision (2018)9029 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/173/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/17/1828 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/17/1828 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/17/1828 (Active substance: 1-(2,2-difluoro-2H-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropane-1-carboxamide and ivacaftor) - Transfer of orphan designation - Commission Decision (2018)9017 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002757

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2109 (Yes Pharmaceutical Development Services GmbH)

EU/3/18/2109 (Yes Pharmaceutical Development Services GmbH)

EU/3/18/2109 (Active substance: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase) - Orphan designation - Commission Decision (2018)9024 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/153/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/12/963 (Helsinn Birex Pharmaceuticals Ltd)

EU/3/12/963 (Helsinn Birex Pharmaceuticals Ltd)

EU/3/12/963 (Active substance: Chlormethine) - Transfer of orphan designation - Commission Decision (2018)9016 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002753

Europe -DG Health and Food Safety