Olmertan

Main information

  • Trade name:
  • Olmertan Combi 40/12.5 olmesartan medoxomil/hydrochlorothiazide 40/12.5 mg film coated tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Olmertan Combi 40/12.5 olmesartan medoxomil/hydrochlorothiazide 40/12.5 mg film coated tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221128
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221128

Olmertan Combi 40/12.5 olmesartan medoxomil/hydrochlorothiazide 40/12.5 mg film coated tablets blister

pack

ARTG entry for

Medicine Registered

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

Australia

ARTG Start Date

5/02/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

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

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

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

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

Products

1. Olmertan Combi 40/12.5 olmesartan medoxomil/hydrochlorothiazide 40/12.5 mg film coated tablets blister

pack

Product Type

Single Medicine Product

Effective date

26/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Indicated for the treatment of hypertension.,Treatment should not be initiated with this fixed dose combination.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Blister Pack

Al/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Olmertan Combi 40/12.5 olmesartan medoxomil/hydrochlorothiazide 40/12.5 mg film coated tablets blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

40/12.5 mg film coated tablets are yellow film coated, oval shaped,

biconvex tablets debossed with L347 on one side and plain on the other

side.

Active Ingredients

Hydrochlorothiazide

12.5 mg

Olmesartan medoxomil

40 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 01:21:07 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

OLMERTAN COMBI®

Olmesartan medoxomil and hydrochlorothiazide

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some

common questions about

OLMERTAN COMBI.

It does not contain all the

available information.

It does not take the place of

talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has

weighed the risks of you taking

OLMERTAN COMBI against

the benefits he/she expects it will

have for you.

If you have any concerns

about taking this medicine,

ask your doctor or

pharmacist.

Keep this leaflet with your

OLMERTAN COMBI

Tablets.

You may need to read it again.

What OLMERTAN

COMBI is used for

OLMERTAN COMBI is

used to treat high blood

pressure which is sometimes

called hypertension.

Everyone has blood pressure.

This pressure helps push blood

all around your body. Your blood

pressure changes at different

times of the day, depending on

how busy or worried you are.

You have hypertension (high

blood pressure) when your blood

pressure stays higher than is

needed, even when you are calm

and relaxed.

There are usually no symptoms

of hypertension. The only way

of knowing that you have

hypertension is to have your

blood pressure checked on a

regular basis. If high blood

pressure is not treated it can lead

to serious health problems,

including stroke, heart disease

and kidney failure.

How OLMERTAN

COMBI works

OLMERTAN COMBI belongs

to a group of medicines known as

angiotensin-II receptor

antagonists. Angiotensin-II is a

substance produced in the body

which causes blood vessels to

tighten. OLMERTAN COMBI

blocks the action of

angiotensin-II and therefore

relaxes your blood vessels. This

helps lower your blood pressure.

OLMERTAN COMBI also

contains a diuretic which reduces

the amount of fluid in the body.

This also helps to lower blood

pressure.

Your doctor may have prescribed

OLMERTAN COMBI for

another reason. Ask your doctor

if you have any questions about

why OLMERTAN COMBI has

been prescribed for you.

OLMERTAN COMBI is not

addictive.

This medicine is available only

with a doctor's prescription.

Before you take

OLMERTAN COMBI

When you must not take it

Do not take OLMERTAN

COMBI if:

you have an allergy to

olmesartan, sulfonamide

derived medicines (e.g.

thiazide diuretics), or any

of the ingredients listed at

the end of this leaflet

Symptoms of an allergic

reaction to OLMERTAN

COMBI may include skin

rash, itchiness, shortness of

breath, swelling of the face,

lips or tongue, muscle pain

or tenderness or joint pain.

you have serious problems

with your kidneys

you have serious problems

with your liver

you have low potassium or

sodium levels in the blood

you have high calcium or

uric acid levels in the blood.

you have diabetes and are

taking a medicine called

aliskiren to reduce blood

pressure.

Do not take OLMERTAN

COMBI if you are pregnant or

breastfeeding.

OLMERTAN COMBI may

enter your womb or it may pass

into the breast milk and there is

the possibility that your baby

may be affected.

If pregnancy is discovered

OLMERTAN COMBI

should be discontinued as

soon as possible.

Do not take OLMERTAN

COMBI after the expiry date

printed on the pack or if the

packaging is torn or shows

signs of tampering.

If you are not sure whether

you should start taking

OLMERTAN COMBI, talk

to your doctor.

Before you start to take it

Tell your doctor if you

have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

Tell your doctor if you have

or have had any medical

conditions, especially the

following:

kidney problems

liver problems

heart problems

diabetes

excessive vomiting or

diarrhoea recently

gout

Systemic Lupus

Erythematosus (SLE)

high levels of potassium in

your blood.

problems with your adrenal

glands (small glands above

the kidneys)

You must also tell your doctor

if you:

are following a very low salt

diet

you are or intend to become

pregnant or plan to

breastfeed.

If you have not told your

doctor about any of the

above, tell him/ her before

you start taking

OLMERTAN COMBI.

Taking other medicines

Tell your doctor or

pharmacist 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 and

OLMERTAN COMBI may

interfere with each other. These

include:

other medicines used to treat

high blood pressure

other diuretics, also known as

fluid or water tablets

non-steroidal

anti-inflammatory drugs

(NSAIDs) or COX-2

inhibitors, medicines used to

relieve pain, swelling and

other symptoms of

inflammation, including

arthritis

potassium supplements or

potassium-containing salt

substitutes

lithium or antidepressant

medicines

insulin and tablets used to

treat diabetes

antacids, medicines used to

treat heartburn and

indigestion

medicines which lower your

immune system, such as

corticosteroids and cytotoxic

medicines used to treat

cancer (including radiation

therapy)

alcohol

laxatives, medicines used to

treat constipation

medicines used to relieve

pain

medicines used to treat

epilepsy

antiarrhythmics which treat

irregular heart beats

muscle relaxants

cholestyramine and

colestipol, used to treat high

cholesterol.

any medicine that contains

aliskiren

These medicines may be affected

by OLMERTAN COMBI, or

may affect how well it works.

You may need different amounts

of your medicine, or you may

need to take different medicines.

Other medicines not listed

above may also interfere with

OLMERTAN COMBI. Your

doctor and pharmacist have

more information on medicines

to be careful with or avoid while

taking this medicine.

Use in children

The safety and effectiveness of

OLMERTAN COMBI in

children has not been

established.

How to take

OLMERTAN COMBI

Follow all directions given to

you by your doctor or

pharmacist carefully.

They may differ from the

information contained in this

leaflet.

Your doctor or pharmacist will

tell you which OLMERTAN

COMBI tablet you will need to

take each day. This depends on

your condition and whether or

not you are taking any other

medicines.

If you do not understand the

instructions on the box, ask

your doctor or pharmacist

for help.

How much to take

The dose of OLMERTAN

COMBI is one tablet to be taken

once a day.

How to take it

Swallow OLMERTAN

COMBI whole with a full

glass of water.

Do not chew the tablets.

When to take it

Take OLMERTAN COMBI

at about the same time each

day, with or without food.

Taking your tablets at the same

time each day will have the best

effect.

It will also help you remember

when to take the tablets. It does

not matter whether you take it

with or without food.

How long to take it

OLMERTAN COMBI helps

control your condition, but does

not cure it. Therefore you must

take OLMERTAN COMBI

every day. Continue taking your

medicine for as long as your

doctor tells you.

If you forget to take it

If it is almost time for your

next dose, skip the dose you

missed and take your next

dose when you are meant to.

Otherwise, take it as soon as

you remember and then go

back to taking your medicine

as you would normally.

Do not take a double dose to

make up for the dose that you

missed.

This may increase the chance of

you getting an unwanted side

effect.

If you are not sure what to

do, ask your doctor or

pharmacist.

If you have trouble

remembering to take your

medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your

doctor or the Australian

Poisons Information Centre

(telephone 13 11 26) or go to

Accident and Emergency at the

nearest hospital, if you think

that you or anyone else may

have taken too much

OLMERTAN COMBI. Do this

even if there are no signs of

discomfort or poisoning.

Keep telephone numbers for

these places handy.

If you take too much

OLMERTAN COMBI, you

may feel light-headed, dizzy or

you may faint. You may also

have a fast heart beat.

While you are using

OLMERTAN COMBI

Things you must do

If you are about to be started

on any new medicine, tell your

doctor, dentist or pharmacist

that you are taking

OLMERTAN COMBI.

Make sure you drink enough

water during exercise and hot

weather when you are taking

OLMERTAN COMBI,

especially if you sweat a lot.

If you do not drink enough water

while taking OLMERTAN

COMBI, you may feel faint,

light-headed or sick. This is

because your blood pressure is

dropping suddenly. If you

continue to feel unwell, tell your

doctor.

If you have excess vomiting

and/or diarrhoea, while taking

OLMERTAN COMBI, tell

your doctor.

You may lose too much water

and salt and your blood pressure

may drop too much.

If you feel light-headed or

dizzy after taking your first

dose of OLMERTAN

COMBI, or when your dose

is increased, tell your doctor

immediately.

If you plan to have surgery

that needs a general

anaesthetic, tell your doctor

or dentist that you are

taking OLMERTAN

COMBI.

Your blood pressure may

drop suddenly.

If you become pregnant while

taking OLMERTAN COMBI,

tell your doctor immediately.

If you are about to have any

blood tests, tell your doctor

that you are taking

OLMERTAN COMBI.

OLMERTAN COMBI may

interfere with the results of some

tests.

Tell your doctor if

photosensitivity reaction

occurs during your treatment.

Tell your doctor

immediately in case of acute

onset of decreased visual

acuity or ocular pain.

Have your blood pressure

checked when your doctor

says, to make sure

OLMERTAN COMBI is

working.

Go to your doctor regularly

for a check-up.

Your doctor may occasionally

do a blood test to check your

potassium levels and see how

your kidneys are working.

Things you must not do

Do not give OLMERTAN

COMBI to anyone else, even

if they have the same

condition as you.

Do not take OLMERTAN

COMBI to treat any other

complaints unless your doctor

or pharmacist tells you to.

Do not stop taking

OLMERTAN COMBI, or

lower the dosage, without

checking with your doctor.

Things to be careful of

If you feel light-headed,

dizzy or faint when getting

out of bed or standing up,

get up slowly.

Standing up slowly,

especially when you get up

from bed or chairs, will

help your body get used to

the change in position and

blood pressure. If this

problem continues or gets

worse, talk to your doctor.

Be careful driving or

operating machinery until

you know how OLMERTAN

COMBI affects you.

As with other medicines in this

class, OLMERTAN COMBI

may cause dizziness,

light-headedness or tiredness in

some people. Make sure you

know how you react to

OLMERTAN COMBI before

you drive a car, operate

machinery, or do anything else

that could be dangerous if you

are dizzy or light-headed. If this

occurs do not drive. If you drink

alcohol, dizziness or

light-headedness may be worse.

Things that would be

helpful for your blood

pressure

Some self help measures

suggested below may help your

condition. Talk to your doctor or

pharmacist about these measures

and for more information.

Alcohol - your doctor may

advise you to limit your

alcohol intake.

Weight - your doctor may

suggest losing some weight

to help lower your blood

pressure and help lessen the

amount of work your heart

has to do. Some people may

need a dietician's help to lose

weight.

Diet - eat a healthy diet

which includes plenty of

fresh vegetables, fruit, bread

(preferably wholegrain),

cereals and fish. Also eat less

sugar and fat (especially

saturated fat) which includes

sausages, fatty meats, full

cream dairy products,

biscuits, cakes, pastries,

chocolates, chips and

coconut. Monounsaturated

and polyunsaturated fats

from olive oil, canola oil,

avocado and nuts are

beneficial in small quantities.

Salt - your doctor may advise

you to watch the amount of

salt in your diet. To reduce

your salt intake you should

avoid using salt in cooking or

at the table and avoid cooked

or processed foods

containing high sodium (salt)

levels.

Exercise – regular exercise,

maintained over the long

term, helps to reduce blood

pressure and helps get the

heart fitter. Regular exercise

also improves your blood

cholesterol levels, helps

reduce your weight and stress

levels, and improves your

sleep, mood and ability to

concentrate. However, it is

important not to overdo it.

Walking is good exercise, but

try to find a route that is

reasonably flat. Before

starting any exercise, ask

your doctor about the best

kind of programme for you.

Smoking - your doctor may

advise you to stop smoking

or at least cut down. There

are enormous benefits to be

gained from giving up

smoking. There are many

professionals, organisations

and strategies to help you

quit. Ask your doctor or

pharmacist for further

information and advice.

Side effects

Tell your doctor or

pharmacist as soon as possible

if you do not feel well while

you are taking OLMERTAN

COMBI.

OLMERTAN COMBI helps

most people with high blood

pressure, but it may have

unwanted side effects in a few

people. All medicines can have

side effects. Sometimes they are

serious, most of the time they are

not. You may need medical

treatment if you get some of the

side effects.

If you are over 65 years of age

you may have an increased

chance of getting side effects.

Ask your doctor or

pharmacist to answer any

questions you may have.

The following is a list of possible

side effects. Do not be alarmed

by this list. You may not

experience any of them.

Tell your doctor or pharmacist

if you notice any of the

following and they worry you:

feeling light-headed, dizzy or

faint

cough

headache

feeling sick (nausea) or

vomiting

stomach pain

diarrhoea or constipation

an uncomfortable feeling in

the stomach

unusual tiredness or

weakness, fatigue

'flu-like' symptoms

runny or blocked nose, or

sneezing

bronchitis

sore throat and discomfort

when swallowing

(pharyngitis)

swelling of the hands, feet or

ankles

back pain

urinary tract infection

jaundice

blurred vision

skin rashes or eczema

sleep disturbance

depression.

These are common side effects.

They are generally mild.

Tell

your

doctor

as

soon

as

possible if you notice any of the

following:

skin rash or itchiness

aching, tender or weak

muscles not caused by

exercise

painful joints

fast heart beat

shortness of breath or

tightness in the chest

swelling of the hands, feet or

ankles

symptoms that may indicate

high potassium levels in the

blood, such as nausea,

diarrhoea, muscle weakness,

change in heart rhythm.

These

serious

side

effects. You may need medical

attention. Serious side effects are

rare.

If any of the following happen,

stop taking OLMERTAN

COMBI and either tell your

doctor immediately or go to

Accident and Emergency at

your nearest hospital:

swelling of the face, lips,

mouth, tongue or throat

which may cause difficulty in

swallowing or breathing

chest pain.

These are very serious side

effects. You may need urgent

medical attention or

hospitalisation. These side

effects are very rare.

Other side effects not listed

above may occur in some

patients. Tell your doctor or

pharmacist if you notice

anything that is making you

feel unwell.

After using OLMERTAN

COMBI

Storage

Keep your tablets in the box

until it is time to take them.

If you take the tablets out of the

box they will not keep well.

Keep your tablets in a cool

dry place where the

temperature stays below

25°C.

Do not store OLMERTAN

COMBI or any other

medicine in the bathroom or

near a sink.

Do not leave it on a

windowsill or in the car on

hot days.

Heat and dampness can destroy

some medicines.

Keep it where children

cannot reach it.

A locked cupboard at least

one-and-a-half metres above the

ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop

taking OLMERTAN COMBI

or the tablets have passed

their expiry date, ask your

pharmacist what to do with

any that are left over.

Product description

What it looks like

OLMERTAN COMBI tablets

come in four strengths and each

has a different appearance:

OLMERTAN COMBI

20/12.5mg is a yellow film

coated, round, biconvex tablet

debossed with ‘346’ on one side

and ‘L’ on other side

OLMERTAN COMBI 20/25mg

is a yellow film coated, oval

shape, biconvex tablets debossed

with‘L400’ on one side and plain

on other side

OLMERTAN COMBI

40/12.5mg is a yellow film

coated, oval shape, biconvex

tablets debossed with‘L347’ on

one side and plain on other side

OLMERTAN COMBI 40/25mg

is a yellow film coated, oval

shape, biconvex tablets debossed

with‘L348’ on one side and plain

on other side

The product is presented in

blister packs of 30 film-coated

tablets.

Ingredients

Active ingredients:

OLMERTAN COMBI 20/12.5 -

20mg olmesartan medoxomil

and 12.5mg hydrochlorothiazide

OLMERTAN COMBI 20/25 -

20mg olmesartan medoxomil

and 25 mg

Hydrochlorothiazide

OLMERTAN COMBI 40/12.5

- 40mg olmesartan medoxomil

and 12.5mg

hydrochlorothiazide

OLMERTAN COMBI 40/25

- 40mg olmesartan

medoxomil and 25mg

hydrochlorothiazide

Other ingredients:

lactose monohydrate

microcrystalline cellulose

hydroxypropylcellulose

magnesium stearate

Opadry Yellow 03F82788

OLMERTAN COMBI does

not contain sucrose, tartrazine

or any other azo dyes.

Supplier

OLMERTAN COMBI is

supplied in Australia by:

Arrow Pharma Pty Ltd

15 – 17 Chapel Street

Cremorne VIC 3121

Australian Registration

Numbers

OLMERTAN COMBI

20/12.5

AUST R 221132

OLMERTAN COMBI 20/25

AUST R 221127

OLMERTAN COMBI

40/12.5 AUST R 221128

OLMERTAN COMBI 40/25

AUST R 221131

This leaflet was prepared in

October 2016.

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

30-10-2018

Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

There is a small increased risk of developing basal cell carcinoma and squamous cell carcinoma in long-term use of blood pressure medicine containing hydrochlorothiazide. This follows from a review of new studies and available data undertaken by the European Medicines Agency, EMA.

Danish Medicines Agency

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

8-3-2012

Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"

Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"

We have completed our review of an application for general reimbursement for Valsartan/Hydrochlorothiazide "Actavis". The product is neither eligible for general nor general conditional reimbursement.

Danish Medicines Agency

22-10-2018

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Teva B.V.)

Irbesartan / Hydrochlorothiazide Teva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018) 6974 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

CoAprovel (Sanofi Clir SNC)

CoAprovel (Sanofi Clir SNC)

CoAprovel (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6465 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

24-9-2018

Karvezide (Sanofi-Aventis groupe)

Karvezide (Sanofi-Aventis groupe)

Karvezide (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6222 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

4-7-2018

Ifirmacombi (Krka d. d., Novo mesto)

Ifirmacombi (Krka d. d., Novo mesto)

Ifirmacombi (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)4340 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

27-6-2018

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4082 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1159/T/67

Europe -DG Health and Food Safety

27-6-2018

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4084 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1160/T/68

Europe -DG Health and Food Safety

11-6-2018

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3752 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1068/T/66

Europe -DG Health and Food Safety