Chemmart

Main information

  • Trade name:
  • Chemmart Alendronate Plus D3 70 mg/70 ug alendronic acid (as sodium) 70 mg and colecalciferol 70 microgram tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Chemmart Alendronate Plus D3 70 mg/70 ug alendronic acid (as sodium) 70 mg and colecalciferol 70 microgram tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220373
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220373

Chemmart Alendronate Plus D3 70 mg/70 ug alendronic acid (as sodium) 70 mg and colecalciferol 70

microgram tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

17/12/2014

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. Chemmart Alendronate Plus D3 70 mg/70 ug alendronic acid (as sodium) 70 mg and colecalciferol 70

microgram tablet blister pack

Product Type

Single Medicine Product

Effective date

28/10/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Alendronate Plus D 70 mg/70 µg and Alendronate Plus D 70 mg/140 µg tablets are indicated for the treatment of:,Osteoporosis in select patients where

vitamin D supplementation is recommended.,Prior to treatment, osteroporosis must be confirmed by:,The finding of low bone mass of at least 2 standard

deviations below the gender specific mean for young adults or by,The presence of osteoporotic fracture

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Chemmart Alendronate Plus D3 70 mg/70 ug alendronic acid (as sodium) 70 mg and colecalciferol 70 microgram tablet blister pack

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White to off-white, biconvex, oval shaped tablet. Engraved "APO" on one

side, "A-D28" on the other side.

Active Ingredients

alendronate sodium

91.37 mg

colecalciferol

70 microgram

© 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 02:31:12 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

Chemmart Alendronate

Plus D3 Tablets

Contains the active ingredient alendronate acid (as alendronate sodium) and colecalciferol (vitamin D3)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about Alendronate Plus

D3. It does not contain all the

available information. It does not

take the place of talking to your

doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is

Chemmart Alendronate Plus D3

tablets. It contains the active

ingredient alendronate sodium and

colecalciferol (vitamin D3).

It is used to:

treat osteoporosis

provide additional vitamin D

Osteoporosis is caused by changes in

the way bone is normally maintained.

Vitamin D is an essential nutrient

required for calcium absorption and

healthy bones.

Understanding bone

Bone is living, growing tissue.

Throughout life, our bodies are

breaking down old bone and

rebuilding new bone in a continuous

cycle. Until our late 20s, while bones

are still developing, we gain bone by

building more than we lose. From

then until about age 35 the process is

usually in balance, so that the amount

of bone lost is about equal to the

amount that is replaced. After about

age 35 this balance is disturbed, with

bone loss occurring at a slightly

faster rate than it can be replaced. In

women, after menopause, hormonal

changes cause bone loss at an even

faster rate. When bone loss is

excessive, bones can become thinner

and weaker, and therefore are more

likely to break.

Osteoporosis

"Osteo" means bone, and "porosis"

means something that has holes in it,

like a sponge. Therefore,

osteoporosis is a disease which

causes bones to become more porous,

gradually making them weaker, more

brittle and likely to break.

Osteoporosis is common in

postmenopausal women. The

menopause occurs when the ovaries

virtually stop producing the female

hormone, oestrogen, or are removed

(which may occur, for example, at

the time of a hysterectomy). At this

time, bone is removed faster than it is

formed, so bone loss occurs and

bones become weaker. The earlier a

woman reaches the menopause, the

greater the risk of osteoporosis.

Osteoporosis also occurs in men but

is less common than in women.

Early on, osteoporosis usually has no

symptoms. However, if left untreated

it can result in broken bones, also

called fractures. Although fractures

usually cause pain, fractures of the

bones of the spine may go unnoticed

until they cause height loss. Fractures

may occur during normal, everyday

activity, such as lifting, or from

minor injury that would not

ordinarily fracture normal bone.

Fractures usually occur at the hip,

spine, or wrist and can lead not only

to pain, but also to considerable

deformity and disability, such as

stooped posture from curvature of the

spine, and loss of mobility.

CHEMMART ALENDRONATE PLUS D3 TABLETS

What should I know about

vitamin D?

Vitamin D is an essential nutrient,

required for calcium absorption and

healthy bones. The main source is

through exposure to summer

sunlight, which makes vitamin D in

our skin. Clothing or sun block can

prevent enough sunlight from getting

through. In addition, as people age,

their skin becomes less able to make

vitamin D. Very few foods are

natural sources of vitamin D.

Too little vitamin D leads to

inadequate calcium absorption and

low phosphate-minerals that make

bones strong. Even if you are eating a

diet rich in calcium or taking a

calcium supplement, your body

cannot absorb calcium properly

unless you have enough vitamin D.

Too little vitamin D may lead to bone

loss and osteoporosis. Severe vitamin

D deficiency may cause muscle

weakness which can lead to falls and

a higher risk of fracture.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

The alendronate in this medicine

works by slowing down the process

of old bone being removed, which

allows the bone-forming cells time to

rebuild normal bone. Alendronate not

only helps prevent the loss of bone

but actually helps to rebuild bone and

make bone less likely to fracture.

Thus, Alendronate Plus D3 reverses

the progression of osteoporosis.

Alendronate Plus D3 starts working

on the bone cells immediately, but

measurable effects on bone mass

may not be seen for several months

or more.

The alendronate in this medicine

belongs to a group of non-hormonal

medicines called bisphosphonates.

In addition to alendronate,

Alendronate Plus D3 also contains

vitamin D3, an essential nutrient

required for calcium absorption and

healthy bones.

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children.

Before you take this

medicine

You should know that in some

people, Alendronate Plus D3 can

irritate or burn the food pipe (also

called oesophagus). The chances of

this happening should be reduced

when you follow the instructions for

'How to take this medicine' in this

leaflet

When you must not take it

Do not take this medicine if:

You have or have had any of

the following:

-

You have certain disorders of

the food pipe (oesophagus)

including those that cause

difficulty in swallowing.

-

You are unable to stand or sit

upright for at least 30 minutes.

-

Your doctor has told you that

you currently have low blood

calcium.

You are hypersensitive to, or

have had an allergic reaction to,

Alendronate, vitamin D or any

of the ingredients listed at the

end of this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

kidney disease

swallowing or digestive

problems, such as ulcers

dental or jaw-bone problems or

are planning to have a course of

dental surgery

You currently smoke or have

been a smoker in the past

You are currently pregnant or you

plan to become pregnant. Do not

take this medicine whilst

pregnant.

You are currently breastfeeding

or you plan to breast-feed. Do not

take this medicine whilst

breastfeeding.

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

CHEMMART ALENDRONATE PLUS D3 TABLETS

Some medicines are likely to

interfere with the absorption of

Alendronate Plus D3. These include:

antacids, medicines used to treat

indigestion

calcium supplements

vitamins

Therefore, take this medicine at

least 30 minutes before taking any

of these or other medicines to make

sure there is no problem with

absorption. Check with your

doctor or pharmacist if you are not

sure whether you are taking any of

these.

Other medicines not listed above

may also interact with Alendronate

Plus D3. If you are taking any of

these you may need a different dose

or you may need to take different

medicines. Your doctor has more

information on medicines to be

careful with or avoid while taking

Alendronate Plus D3.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

The usual dose of Alendronate Plus

D3 is one tablet once a week.

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition

and whether you are taking any other

medicines.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

How to take it

Swallow one tablet whole with a full

glass of plain water.

Do not take any food, medicines or

drinks other than plain tap water

with this medicine.

It is important to take Alendronate

Plus D3 with plain water only, not

mineral water. Food, other drugs and

mineral water and other drinks,

including fruit juices, coffee and tea,

will reduce the effect of this

medicine by interfering with the

absorption into the body.

Stay upright for at least 30 minutes

after swallowing Alendronate Plus

D3 and do not take any food,

medicines or drinks other than

plain tap water during this time.

Do not lie down immediately after

swallowing it.

It is important to stay upright (sitting,

standing or walking around) for at

least 30 minutes after swallowing

your tablet. It is also very important

to stay upright until after you have

eaten your first food of the day.

These actions will help make sure

your tablet reaches your stomach

quickly and help reduce the potential

for irritation to your food pipe

(oesophagus).

Do not chew or suck on a tablet of

Alendronate Plus D3.

Mouth ulcers may occur if the tablet

is chewed or dissolved in the mouth.

When to take it

Take Alendronate Plus D3 after

getting up for the day. Do not take

it at bedtime.

Choose the day of the week that

best fits your schedule. Every

week, take one tablet of

Alendronate Plus D3 on your

chosen day.

Alendronate Plus D3 is effective only

if taken when your stomach is empty.

Food, drinks other than plain water,

and other medicines will lessen the

effect of Alendronate Plus D3 by

interfering with its absorption into

the body.

How long to take it for

It is important that you continue

taking Alendronate Plus D3 for as

long as your doctor prescribes.

Alendronate Plus D3 can only treat

your osteoporosis, by helping prevent

further loss of bone and continuing to

rebuild bone, if you take it every

week.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If you miss a tablet, take one tablet

on the morning after you

remember.

Do not take two tablets on the

same day to make up for missed

doses. Return to taking one tablet

once a week, as originally

scheduled on your chosen day.

If you have trouble remembering to

take your medicine, ask your doctor

for some hints to help you remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

If you take too many tablets at one

time, drink a full glass of milk. Do

not induce vomiting. Do not lie

down

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you develop difficulty or pain

upon swallowing, chest pain, or

new or worsening heartburn

you develop a toothache or

require a dental procedure

CHEMMART ALENDRONATE PLUS D3 TABLETS

you develop new or unusual pain

in your leg

Rarely, patients have experienced

fracture in a specific part of the

thigh bone.

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Make sure you have an adequate

intake of calcium in your diet. Your

doctor, dietician or pharmacist can

tell you what foods you should eat.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

There have been side effects reported

with this medicine that may affect

your ability to drive or operate

machinery. Individual responses to

this medicine may vary (see Possible

side effects).

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking this medicine or if you have

any questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

stomach pain, gas in the stomach

or bowel, wind

an uncomfortable feeling in the

stomach or belching after eating,

also called dyspepsia, or

heartburn

feeling sick (nausea), vomiting

constipation, diarrhoea

headache

aching muscles, joints and/or

bones, which rarely can be severe

flu-like symptoms typically at the

start of treatment, such as aching

muscles, generally feeling unwell

and rarely fever

swelling of joints

dizziness or spinning sensation

unusual tiredness or weakness

swelling of hands, ankles or feet

hair loss

changed sense of taste

Tell your doctor immediately if

you notice any of the following:

skin rash or redness of the skin,

sometimes made worse by

sunlight, itchiness

mouth ulcers

blurred vision, pain or redness in

the eye

symptoms of low blood calcium

levels including muscle cramps or

spasms or tingling sensation in

the fingers or around the mouth

new or unusual pain in your hip

or thigh

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects and

you may need medical attention:

jaw-bone or dental problems

(including toothache). Jaw-bone

problems may include infection,

and delayed healing after a tooth

extraction or other work that

involves drilling into the jaw-

bone

difficulty or pain upon

swallowing

chest pain

new or worsening heartburn.

These side effects may be due to

irritation or ulceration of the food

pipe. They may worsen if you

continue taking the tablets. Rarely,

these side effects may be serious.

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious side effects

and you may need urgent medical

attention or hospitalisation:

swelling of the face, lips, mouth,

throat or tongue which may cause

difficulty in breathing or

swallowing,

pinkish, itchy swellings on the

skin, also called hives or

nettlerash

severe skin reactions

black tar-like and/or bloody

stools

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to Alendronate

Plus D3, do not take any more of

this medicine and tell your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

CHEMMART ALENDRONATE PLUS D3 TABLETS

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 25°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep 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

this medicine or it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What Chemmart

Alendronate Plus D3 tablets

looks like

70mg/70mcg tablets:

White to off-white biconvex, oval

shaped tablet. Engraved "APO" on

one side, "A-D28" on the other side.

Blister Pack of 4

70mg/140 mcg tablets:

White to off-white, rectangular,

biconvex tablet. Engraved "APO" on

one side, "ALE-D56" on the other

side.

Blister Pack of 4

* Not all strengths, pack types and/or

pack sizes may be available.

Ingredients

Each tablet contains 70 mg

alendronate acid (as alendronate

sodium) and 70 mcg or 140 mcg

colecalciferol (vitamin D3) as the

active ingredients.

It also contains the following inactive

ingredients:

mannitol

microcrystalline cellulose

colloidal anhydrous silica

magnesium stearate

hypromellose

butylated hydroxytoluene.

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

Chemmart Alendronate Plus D3 70

mg/70 mcg tablets (blister pack):

AUST R 220373.

Chemmart Alendronate Plus D3 70

mg/140 mcg tablets (blister pack):

AUST R 220377.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

This leaflet was last updated in:

December 2014.

CHEMMART ALENDRONATE PLUS D3 TABLETS

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Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

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

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

15-3-2019


Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

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

15-3-2019

EU/3/16/1800 (Boyd Consultants Limited)

EU/3/16/1800 (Boyd Consultants Limited)

EU/3/16/1800 (Active substance: Dantrolene sodium) - Transfer of orphan designation - Commission Decision (2019)2111 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005192

Europe -DG Health and Food Safety

14-3-2019


Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

28-2-2019

EU/3/04/197 (Unither Therapeutik GmbH)

EU/3/04/197 (Unither Therapeutik GmbH)

EU/3/04/197 (Active substance: Treprostinil sodium (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)1741 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004330

Europe -DG Health and Food Safety

21-2-2019


Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/08/554 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/08/554 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/08/554 (Active substance: Beraprost sodium (modified release tablet)) - Transfer of orphan designation - Commission Decision (2019)1354 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003232

Europe -DG Health and Food Safety

4-2-2019

Elmiron (bene-Arzneimittel GmbH)

Elmiron (bene-Arzneimittel GmbH)

Elmiron (Active substance: pentosan polysulfate sodium) - Centralised - Yearly update - Commission Decision (2019)848 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Europe - EMA - European Medicines Agency

24-1-2019


Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Europe - EMA - European Medicines Agency

21-1-2019

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names (Active substance: Diclofenac sodium) - Community Referrals - Art 29 - Commission Decision (2019)589 of Mon, 21 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1467

Europe -DG Health and Food Safety

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Europe - EMA - European Medicines Agency

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

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

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Active substance: (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-beta-D-galactopyranosyl]-4-O-(a-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide) - Transfer of orphan designation - Commission Decision (2018)7836 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/13/T/01

Europe -DG Health and Food Safety

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30

Europe -DG Health and Food Safety