TELMISARTAN

Main information

  • Trade name:
  • TELMISARTAN HCT GH 80/25mg telmisartan 80mg and hydrochlorothiazide 25mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TELMISARTAN HCT GH 80/25mg telmisartan 80mg and hydrochlorothiazide 25mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208076
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208076

TELMISARTAN HCT GH 80/25mg telmisartan 80mg and hydrochlorothiazide 25mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Generic Health Pty Ltd

Postal Address

Level 1 / 1102 Toorak Road,CAMBERWELL, VIC, 3124

Australia

ARTG Start Date

8/04/2014

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. TELMISARTAN HCT GH 80/25mg telmisartan 80mg and hydrochlorothiazide 25mg tablet blister pack

Product Type

Single Medicine Product

Effective date

9/01/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

TELMISARTAN HCT GH is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. TELMISARTAN HCT GH 80/25mg telmisartan 80mg and hydrochlorothiazide 25mg tablet blister pack

Dosage Form

Tablet, multilayer

Route of Administration

Oral

Visual Identification

Oblong shaped biconvex, bilayered, uncoated tablets with one white/off

white color layer and one yellow colour mottled layer debossed with L201

Active Ingredients

Hydrochlorothiazide

25 mg

Telmisartan

80 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 11:31:12 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

TELMISARTAN HCT GH

Tablets

Telmisartan and Hydrochlorothiazide

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about

TELMISARTAN HCT GH.

It does not contain all available information. It

does not take the place of talking to your doctor or

pharmacist.

This leaflet was last updated on the date at the end

of this leaflet. More recent information may be

available.

The latest Consumer Medicine Information is

available from your pharmacist, doctor, or from

www.medicines.org.au and may contain important

information about the medicine and its use of

which you should be aware.

All medicines have benefits and risks. Your doctor

has weighed the risks of you taking this medicine

against the benefits it is expected to have for you.

If you have any concerns about this medicine,

ask your doctor or pharmacist. Keep this leaflet

with the medicine.

You may need to read it again.

What TELMISARTAN HCT GH

is used for

TELMISARTAN HCT GH is used to lower high

blood pressure (hypertension).

Everyone has blood pressure. This pressure helps

your blood move around your body. Your blood

pressure may be different 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 or relaxed. There are

usually no signs 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 TELMISARTAN HCT GH works

TELMISARTAN HCT GH contains telmisartan

and hydrochlorothiazide in one single tablet. These

two active ingredients help to reduce blood

pressure in different ways:

Telmisartan belongs to a group of

medicines called angiotensin II receptor

antagonists. Angiotensin II is a substance

in the body which causes blood vessels to

narrow, thus increasing blood pressure.

Telmisartan works by blocking the effect

of angiotensin II. When the effect of

angiotensin II is blocked, your blood

vessels relax and your blood pressure goes

down.

Hydrochlorothiazide belongs to the group

of medicines called diuretics. Diuretics

help to reduce the amount of excess fluid

in the body by increasing the amount of

urine produced. They help with lowering

blood pressure particularly when used

with other blood pressure lowering

medicines. Your doctor may have

prescribed TELMISARTAN HCT GH for

another reason.

Ask your doctor if you have any questions about

why TELMISARTAN HCT GH has been

prescribed for you. TELMISARTAN HCT GH is

not addictive. This medicine is available only with

a doctor’s prescription.

Use in Children

The safety and effectiveness of TELMISARTAN

HCT GH in children and teenagers up to 18 years

of age have not been established.

Before you take

TELMISARTAN HCT GH

When you must not take it

Do not take TELMISARTAN HCT GH if you

have ever had an allergic reaction after taking:

Telmisartan or hydrochlorothiazide (the

two active ingredients in TELMISARTAN

HCT GH ),

other sulfonamide-derived medicines

any of the other ingredients listed at the

end of this leaflet.

Symptoms of an allergic reaction to

TELMISARTAN HCT GH may include skin rash,

itchiness, shortness of breath, swelling of the face,

lips or tongue, muscle pain or tenderness or joint

pain.

Do not take TELMISARTAN HCT GH if you

have a rare hereditary condition of fructose

intolerance.

The maximum recommended daily dose of

TELMISARTAN HCT GH contains 169 mg of

sorbitol (in the 40/12.5 mg tablets) and

approximately 338 mg of sorbitol (in the 80/12.5

mg and 80/25 mg tablets).

Do not take TELMISARTAN HCT GH if you

have a rare hereditary condition of galactose

intolerance.

The maximum recommended daily dose of

TELMISARTAN HCT GH contains 112 mg of

lactose (in the 40/12.5 mg and 80/12.5 mg tablets)

and 99 mg of lactose (in the 80/25 mg tablets).

Do not take TELMISARTAN HCT GH if you

are pregnant or intend to become pregnant.

TELMISARTAN HCT GH is not recommended for

use in pregnancy. Like other similar medicines, it

could affect your unborn baby if you take it during

pregnancy.

Do not breast-feed if you are taking

TELMISARTAN HCT GH.

It is not known if telmisartan or

hydrochlorothiazide, the active ingredients in

TELMISARTAN HCT GH, pass into breast milk

and there is a possibility that your baby may be

affected.

Do not take TELMISARTAN HCT GH if you

have any of the following medical conditions:

severe liver disease

severe kidney disease

cholestasis or biliary obstructive disorders

(problem with the flow of bile from the

gall bladder)

low potassium levels in the blood

high calcium levels in the blood.

Do not take TELMISARTAN HCT GH after the

expiry date printed on the pack.

Do not take TELMISARTAN HCT GH if the

packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your

pharmacist for disposal.

If you are not sure whether you should start

taking TELMISARTAN HCT GH, 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

a condition known as primary

hyperaldosteronism (raised aldosterone

levels, also known as Conn’s syndrome)

diabetes

gout

fructose intolerance

galactose intolerance

a low salt diet

recent severe diarrhoea or vomiting

asthma

systemic lupus erythematosus (a disease

affecting the skin, joints and kidney)

Tell your doctor if you are following a very low

salt diet.

Tell your doctor if you plan to become pregnant

or breastfeed.

If you have not told your doctor about any of the

above, tell your doctor before you take

TELMISARTAN HCT GH .

Taking other medicines

Tell your doctor or pharmacist if you are

taking any other medicines, including any that

you get without a prescription from your

pharmacy, supermarket or health food shop.

Some medicines and TELMISARTAN HCT GH

may interfere with each other. These include:

any other medicines used to treat high

blood pressure such as beta blockers

heart medicines such as digoxin, a

medicine used to treat heart failure or

antiarrhythmic medicines

lithium, a medicine used to treat certain

mental illnesses

other diuretics or fluid tablets medicines

used to help the kidneys get rid of salt and

water by increasing the amount of urine

produced

laxatives

potassium supplements or potassium-

containing salt substitutes

medicines or salt substitutes which may

increase your potassium levels

alcohol

sleeping tablets

strong pain killing medicines

medicines for diabetes (oral tablets or

capsules or insulin)

powder or granules used to help reduce

cholesterol

corticosteroid medicines such as

prednisolone, cortisone or ACTH

aspirin

nonsteroidal anti-inflammatory agents

(medicines used to relieve pain, swelling

and other symptoms of inflammation

including arthritis)

medicines used to treat gout

calcium supplements or medicines

containing calcium

anticholinergic medicines, which can be

used to treat Parkinson’s disease, relieve

stomach cramps or prevent travel sickness

amantadine, a medicine used to treat

Parkinson’s disease or to prevent influenza

medicines used to treat cancer (cytotoxic

medicines)

These medicines may be affected by

TELMISARTAN HCT GH, or may affect the way

it works. Also, other medicines used to treat high

blood pressure may have an additive effect with

TELMISARTAN HCT GH in lowering your blood

pressure. Therefore, you may need different

amounts of your medicines.

Your doctor or pharmacist may have more

information on medicines to be careful with or

avoid while taking TELMISARTAN HCT GH.

How to take TELMISARTAN

HCT GH

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

how many tablets 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

label, ask your doctor or pharmacist for help.

How much to take

The usual dose for adults is one TELMISARTAN

HCT GH 40/12.5 mg tablet once a day. If your

blood pressure is still too high after 4-8 weeks of

starting treatment, your doctor may increase your

dose to one TELMISARTAN HCT GH 80/12.5 mg

tablet once a day.

If your blood pressure is still not satisfactorily

controlled with TELMISARTAN HCT GH 80/12.5

mg, your doctor may increase your dose to one

TELMISARTAN HCT GH 80/25 mg tablet once a

day.

It is important to take TELMISARTAN HCT

GH exactly as your doctor or pharmacist has

told you.

When to take it

Take TELMISARTAN HCT GH at about the

same time each day, either morning or evening.

Taking it at the same time each day will have the

best effect. It will also help you remember when to

take it.

It does not matter if you take TELMISARTAN

HCT GH before or after food.

How to take it

Swallow the tablet whole with a full glass of

water.

You can take TELMISARTAN HCT GH with or

without food.

How long to take it

Take TELMISARTAN HCT GH every day until

your doctor tells you to stop.

TELMISARTAN HCT GH helps control your high

blood pressure but does not cure it. It is important

to keep taking TELMISARTAN HCT GH every

day even if you feel well.

People who have high blood pressure often feel

well and do not notice any signs of this problem.

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 the dose as

soon as you remember, and then go back to

taking it as you would normally.

Do not take a double dose to make up for the

dose that you missed.

This may increase the chance of you getting

unwanted side effects.

If you have trouble remembering when to take

your medicine, ask your pharmacist for some

hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons

Information Centre (telephone 13 11 26) for

advice or go to Accident and Emergency at your

nearest hospital, if you think that you or anyone

else may have taken too much TELMISARTAN

HCT GH.

Do this even if there are no signs of discomfort

or poisoning.

You may need urgent medical attention. If you take

too much TELMISARTAN HCT GH you may feel

dizzy, light-headed or faint. Your heartbeat may be

faster or lower than usual. You may experience

dehydration, nausea, drowsiness and muscle spasm.

While you are taking

TELMISARTAN HCT GH

Things you must do

Tell any other doctors, dentists and pharmacists

who are treating you that you are taking

TELMISARTAN HCT GH.

If you are about to be started on any new

medicine, tell your doctor or pharmacist that

you are taking TELMISARTAN HCT GH.

If you feel that TELMISARTAN HCT GH is

not helping your condition, tell your doctor or

pharmacist.

Tell your doctor if, for any reason, you have not

used TELMISARTAN HCT GH exactly as

prescribed.

Otherwise, your doctor may think that it was not

effective and change your treatment unnecessarily.

Tell your doctor immediately if you become

pregnant while taking TELMISARTAN HCT

GH.

You should not take this medicine while you are

pregnant.

If you are going to have surgery, tell your doctor

and anaesthetist that you are taking

TELMISARTAN HCT GH.

TELMISARTAN HCT GH may affect some

medicines you receive during surgery.

Things you must not do

Do not use TELMISARTAN HCT GH to treat

other complaints unless your doctor or

pharmacist tells you to.

Do not give this medicine to anyone else, even if

they have the same symptoms as you.

Things to be careful of

Be careful when driving or operating

machinery until you know how

TELMISARTAN HCT GH affects you.

Like other medicines used to treat high blood

pressure, TELMISARTAN HCT GH may cause

sleepiness, dizziness or lightheadedness in some

people.

If you have any of these symptoms, do not drive,

operate machinery or do anything else that

could be dangerous.

You may feel dizzy or light-headed when you

begin to take TELMISARTAN HCT GH ,

especially if you are also taking a diuretic (or fluid

tablet) or if you are dehydrated.

If this medicine makes you feel dizzy or light-

headed, be careful when getting up from a

sitting or lying position.

Standing up slowly, especially when you get up

from a bed or chair, 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.

If you exercise, or if you sweat, or if the weather

is hot, you should drink plenty of water.

Side effects

Tell your doctor or pharmacist as soon as

possible if you do not feel well while you are

taking TELMISARTAN HCT GH even if you

do not think it is connected with the medicine.

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.

Do not be alarmed by this list of possible side

effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any

questions you may have. Tell your doctor if you

notice any of the following and they worry you:

‘flu-like’ symptoms

fainting, dizziness or spinning sensation

a feeling of tension or fullness in the nose,

cheeks and behind the eyes, sometimes

with a throbbing ache (sinusitis)

infections of the air passages

shortness of breath or difficulty breathing

abnormal or blurred vision

back pain

changes in heart rhythm or increased heart

rate

rash or redness or itchiness of skin

increased sweating

dizziness or lightheadedness when you

stand up (postural hypotension)

stomach pain or discomfort (abdominal

pain, dyspepsia, gastritis)

wind or excessive gas in the stomach or

bowel

vomiting

diarrhoea or constipation

dry mouth

pins and needles

sleep disturbances or trouble sleeping

feeling anxious

depression

impotence

leg pain or cramps in legs

aching muscles or aching joints not caused

by exercise or muscle spasms

chest pain

pain

liver problems

changes in the levels of potassium or

sodium or uric acid in your blood (such

changes are usually detected by a blood

test)

Tell your doctor as soon as possible if you

experience any side effects during or after

taking TELMISARTAN HCT GH , so that

these may be properly treated.

Symptoms such as feeling very thirsty, sleepy, sick

or vomiting, a dry mouth, general weakness,

muscle pain or cramps, a very fast heart rate, may

mean that the hydrochlorothiazide part of

TELMISARTAN HCT GH is having an excessive

effect.

You should tell your doctor if you experience

any of these symptoms. Tell your doctor

immediately or go to casualty at your nearest

hospital if you notice any of the following:

swelling of the face, lips, mouth, tongue or

throat which may cause difficulty in

swallowing or breathing

severe and sudden onset of pinkish, itchy

swellings on the skin, also called hives or

nettle rash

developing or worsening of a disease

called systemic lupus erythematosus

which affects the skin, joints and kidney

These are serious side effects. You may need

urgent medical attention or hospitalisation. These

side effects are rare.

Tell your doctor if you notice anything else that

is making you unwell.

Other side effects not listed above may also occur

in some people.

After taking TELMISARTAN

HCT GH

Storage

Leave the tablets in the blister strip until it is

time to take a dose.

The blister pack protects the tablets from light and

moisture.

Keep TELMISARTAN HCT GH in a cool, dry

place where the temperature stays below 25

C.

Do not store TELMISARTAN HCT GH or any

other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep TELMISARTAN HCT GH where young

children cannot reach it.

Disposal

If your doctor tells you to stop using

TELMISARTAN HCT GH or it has passed its

expiry date, ask your pharmacist what to do

with any that is left over.

Product description

What it looks like

TELMISARTAN HCT GH is the brand name of

your medicine. TELMISARTAN HCT GH tablets

are available in three strengths: 40/12.5 mg,

80/12.5 mg and 80/25 mg tablets.

TELMISARTAN HCT GH 40/12.5 mg and 80/12.5

mg tablets are pink mottled and white to off-white

biconvex, oval shaped, two layer tablets. The

white to off-white layer may contain pink specks.

Each tablet contains either 40 mg or 80 mg of

telmisartan and 12.5 mg of hydrochlorothiazide.

The pink mottled face of TELMISARTAN HCT

GH 40/12.5 mg tablets are marked with L199. The

pink mottled face of TELMISARTAN HCT GH

80/12.5 mg tablets are marked with L200.

TELMISARTAN HCT GH 80/25 mg tablets are

yellow mottled and white to off-white biconvex,

oval shaped, two layer tablets. The white to off-

white layer may contain yellow specks. Each tablet

contains 80 mg of telmisartan and 25 mg of

hydrochlorothiazide. The white face of

TELMISARTAN HCT GH 80/25 mg tablets are

marked with L201.

TELMISARTAN HCT GH tablets are available in

blister packs of 28 tablets.

The following Australian Registration Numbers

appear on the carton:

AUST R 208070for TELMISARTAN HCT GH

40/12.5 mg tablets

AUST R 208075for TELMISARTAN HCT GH

80/12.5 mg tablets

AUST R 208076 for TELMISARTAN HCT GH

80/25 mg tablets

Ingredients

Each TELMISARTAN HCT GH 40/12.5 mg tablet

contains 40 mg telmisartan and 12.5 mg

hydrochlorothiazide.

Each TELMISARTAN HCT GH 80/12.5 mg tablet

contains 80 mg telmisartan and 12.5 mg

hydrochlorothiazide.

Each TELMISARTAN HCT GH 80/25 mg tablet

contains 80 mg telmisartan and 25 mg

hydrochlorothiazide.

The other ingredients found in the tablets are:

povidone (K25)

lactose

magnesium stearate

meglumine

sodium hydroxide

sodium stearyl fumarate

mannitol

TELMISARTAN HCT GH 40/12.5 mg and 80/12.5

mg tablets also contain Pigment Blend PB-24880

Pink and TELMISARTAN HCT GH 80/25 mg

tablets also contain Pigment Blend PB-52290

Yellow, as colouring agent.

Sponsor

GENERIC HEALTH PTY LTD

Level 1, 1102 Toorak Road

Camberwell VIC 3124

This leaflet was last updated in

September 2015

9-11-2018

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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

24-5-2018

FDA Approves Semintra, the First FDA-approved Animal Drug for the Control of Systemic Hypertension in Cats

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The FDA has approved Semintra (telmisartan oral solution), the first FDA-approved animal drug to control systemic hypertension in cats. Semintra is an oral solution administered either directly into the cat’s mouth or on top of a small amount of food.

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

25-10-2018

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Europe -DG Health and Food Safety

2-10-2018

CoAprovel (Sanofi Clir SNC)

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Europe -DG Health and Food Safety

24-9-2018

Karvezide (Sanofi-Aventis groupe)

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Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

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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)

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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

4-6-2018

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Active substance: telmisartan / amlodipine) - Centralised - Yearly update - Commission Decision (2018)3625 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

16-5-2018

Semintra (Boehringer Ingelheim Vetmedica GmbH)

Semintra (Boehringer Ingelheim Vetmedica GmbH)

Semintra (Active substance: Telmisartan) - Centralised - Variation - Commission Decision (2018)3020 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2436/X/8

Europe -DG Health and Food Safety

16-3-2018

Pending EC decision:  Semintra, telmisartan, Opinion date: 15-Mar-2018

Pending EC decision: Semintra, telmisartan, Opinion date: 15-Mar-2018

Europe - EMA - European Medicines Agency