Segluromet

Main information

  • Trade name:
  • Segluromet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Segluromet
    European Union
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Drugs used in diabetes, , Combinations of oral blood glucose lowering drugs
  • Therapeutic area:
  • Diabetes Mellitus, Type 2
  • Therapeutic indications:
  • Segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: • in patients not adequately controlled on their maximally tolerated dose of metformin alone • in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes • in patients already being treated with the combination of ertugliflozin and metformin as separate tablets.
  • Product summary:
  • Revision: 1

Other information

Status

  • Source:
  • EMA - European Medicines Agency
  • Authorization status:
  • Authorised
  • Authorization number:
  • EMEA/H/C/004314
  • Authorization date:
  • 23-03-2018
  • EMEA code:
  • EMEA/H/C/004314
  • Last update:
  • 08-01-2019

Public Assessment Report

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

EMA/90238/2018

EMEA/H/C/004314

Segluromet (ertugliflozin / metformin hydrochloride)

An overview of Segluromet and why it is authorised in the EU

What is Segluromet and what is it used for?

Segluromet is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes. It

is used together with diet and exercise in the following patients:

patients whose glucose levels are not well controlled with the highest dose of metformin they can

take

patients on the highest dose of metformin they can take who are also taking another diabetes

medicine

patients who are already taking ertugliflozin and metformin as separate tablets.

Segluromet contains two active substances, ertugliflozin and metformin.

How is Segluromet used?

Segluromet is available as tablets in 4 strengths of ertugliflozin and metformin (2.5 mg/850 mg,

2.5 mg/1,000 mg, 7.5 mg/850 mg and 7.5 mg/1,000 mg).

The strength of Segluromet tablet to use depends on how well the patient’s glucose levels are

controlled. The dose is one tablet twice a day with food.

The doctor will check how well the patient’s kidneys are working before treatment and once a year

during treatment. The dose of Segluromet may be reduced or it may be stopped if the kidneys are not

working well enough. Treatment will not be started if the kidney function is poor.

For more information about using Segluromet, see the package leaflet or contact your doctor or

pharmacist. Segluromet can only be obtained with a prescription.

How does Segluromet work?

Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of

glucose in the blood or when the body is unable to use insulin effectively. The result is a high level of

glucose in the blood.

Segluromet (ertugliflozin / metformin hydrochloride)

EMA/90238/2018

Page 2/3

The two active substances in Segluromet, ertugliflozin and metformin, work in different ways to lower

glucose levels.

Ertugliflozin helps to lower blood glucose by making the patient pass out glucose in the urine. It does

this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood

from the kidneys.

Metformin, on the other hand, works mainly by blocking glucose production in the body and by

reducing the absorption of glucose in the gut.

What benefits of Segluromet have been shown in studies?

Four main studies in over 3,600 patients with type 2 diabetes have shown that adding ertugliflozin to

metformin helps lower glucose levels when metformin is not working well enough. The studies looked

mainly at effects on levels of HbA1c (a measure of blood glucose) after 6 months or one year of

treatment. At the start of the studies, patients’ HbA1c was above 7 percentage points. The results

were as follows:

The first study found that in patients taking a combination of ertugliflozin and metformin, HbA1c

levels fell by around 0.8 points, compared with reductions of 0.03 when placebo (a dummy

treatment) was added to metformin.

A second study found that adding ertugliflozin to a combination of sitagliptin (another diabetes

medicine) and metformin was more effective than placebo. HbA1c levels fell by between 0.8 and

0.9 percentage points when ertugliflozin was added, compared with a fall of 0.1 with placebo

A third study found that a combination of ertugliflozin at a 15 mg dose with metformin was about

as effective as a combination of metformin with another diabetes medicine, glimepiride. In this

study, HbA1c levels fell by 0.6 points with ertugliflozin and 0.7 points with glimepiride. A lower

dose of ertugliflozin 5 mg was less effective.

The fourth study found that, in patients taking metformin, adding ertugliflozin was as effective as

adding sitagliptin with HbA1c levels falling by around 1 point with both treatments. HbA1c levels

fell by a further 0.5 points when both medicines were added to metformin.

Finally, in addition to lowering glucose levels, studies showed that adding ertugliflozin to metformin

helped patients reduce bodyweight.

What are the risks associated with Segluromet?

The most common side effects with Segluromet (which may affect more than 1 in 10 people) are

fungal infections of the vagina and other infections of the female reproductive system and problems

with the gut such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. For the full list

of side effects of Segluromet, see the package leaflet.

Segluromet must not be used in patients with uncontrolled diabetes with severe symptoms that lead to

high acid levels in the blood. It must also not be used in patients with severe kidney problems or

certain heart, circulatory, breathing or liver problems and in patients who drink alcohol to excess. For

the full list of restrictions, see the package leaflet.

Segluromet (ertugliflozin / metformin hydrochloride)

EMA/90238/2018

Page 3/3

Why is Segluromet authorised in the EU?

Studies showed that Segluromet can help lower glucose levels in patients whose metformin treatment

is not working well enough, including those taking another diabetes medicine in addition to metformin.

Segluromet can also help some patients lose weight.

Steglatro is not as effective in patients with moderate kidney impairment and should therefore not be

started in such patients.

The European Medicines Agency concluded that Segluromet’s benefits are greater than its risks and it

can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of

Segluromet?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Segluromet have been included in the summary of product characteristics and the

package leaflet.

As for all medicines, data on the use of Segluromet is continuously monitored. Side effects reported

with Segluromet are carefully evaluated and any necessary action taken to protect patients.

Other information about Segluromet

Segluromet received a marketing authorisation valid throughout the EU on 23 March 2018.

Further information on Segluromet can be found on the Agency’s website: ema.europa.eu/Find

medicine/Human medicines/European public assessment reports.

This overview was last updated in 04-2018.

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Segluromet 2.5 mg/850 mg film-coated tablets

Segluromet 2.5 mg/1,000 mg film-coated tablets

Segluromet 7.5 mg/850 mg film-coated tablets

Segluromet 7.5 mg/1,000 mg film-coated tablets

ertugliflozin/metformin hydrochloride

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist, or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Segluromet is and what it is used for

What you need to know before you take Segluromet

How to take Segluromet

Possible side effects

How to store Segluromet

Contents of the pack and other information

1.

What Segluromet is and what it is used for

What Segluromet is

Segluromet contains two active substances, ertugliflozin and metformin.

Ertugliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2)

inhibitors.

Metformin belongs to a group of medicines called biguanides.

What Segluromet is used for

Segluromet lowers blood sugar levels in adult patients (aged 18 years and older) with type 2

diabetes.

Segluromet can be used instead of taking both ertugliflozin and metformin as separate tablets.

Segluromet can be used alone or with some other medicines that lower blood sugar.

You need to keep following your food and exercise plan while taking Segluromet.

How Segluromet works

Ertugliflozin works by blocking the SGLT2 protein in your kidneys. This causes blood sugar to

be removed in your urine.

Metformin works by inhibiting sugar (glucose) production in the liver.

What is type 2 diabetes?

Type 2 diabetes is a condition in which your body does not make enough insulin or the insulin that

your body produces does not work as well as it should. Your body can also make too much sugar.

When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems,

like heart disease, kidney disease, blindness and poor circulation.

2.

What you need to know before you take Segluromet

Do not take Segluromet:

if you are allergic to ertugliflozin or metformin or any of the other ingredients of this medicine

(listed in section 6).

if you have severely reduced kidney function or need dialysis.

if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood

glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic

acidosis” below) or ketoacidosis. Ketoacidosis is a condition in which substances called ‘ketone

bodies’ accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include

stomach pain, fast and deep breathing, sleepiness, or your breath developing an unusual fruity

smell.

if you have a severe infection or are dehydrated.

if you have recently had a heart attack or have severe circulatory problems, such as ‘shock’ or

breathing difficulties.

if you have liver problems.

if you drink alcohol to excess (either regularly or from time to time).

Do not take Segluromet if any of the above apply to you. If you are not sure, talk to your doctor before

taking Segluromet.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before and while taking Segluromet, if you:

have kidney problems.

have or have had yeast infections of the vagina or penis.

have ever had serious heart disease or if you have had a stroke.

have type 1 diabetes. Segluromet should not be used to treat this condition.

take other diabetes medicines; you are more likely to get low blood sugar with certain

medicines.

might be at risk of dehydration (for example, if you are taking medicines that increase urine

production [diuretics] lower blood pressure or if you are over 65 years old). Ask about ways to

prevent dehydration.

experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and

deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet

or metallic taste in your mouth or a different odour to your urine or sweat, contact a doctor or

the nearest hospital straight away. These symptoms could be a sign of “diabetic ketoacidosis” –

a problem you can get with diabetes because of increased levels of “ketone bodies” in your

urine or blood, seen in tests. The risk of developing diabetic ketoacidosis may be increased with

prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin

dose, or a higher need of insulin due to major surgery or serious illness.

When this medicine is used in combination with insulin or medicines that increase insulin release from

the pancreas, low blood sugar (hypoglycaemia) can occur. Your doctor may reduce the dose of your

insulin or other medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Risk of lactic acidosis

Segluromet may cause a very rare, but very serious side effect called lactic acidosis, particularly if

your kidneys are not working properly. The risk of developing lactic acidosis is also increased with

uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further

information below), liver problems and any medical conditions in which a part of the body has a

reduced supply of oxygen (such as acute severe heart disease).

If any of the above apply to you, talk to your doctor for further instructions.

Stop taking Segluromet for a short time if you have a condition that may be associated with

dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to

heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Segluromet and contact a doctor or the nearest hospital immediately if you

experience some of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

vomiting

stomach ache (abdominal pain)

muscle cramps

a general feeling of not being well with severe tiredness

difficulty in breathing

reduced body temperature and heartbeat

Lactic acidosis is a medical emergency and must be treated in a hospital.

If you need to have major surgery you must stop taking Segluromet during and for some time after the

procedure. Your doctor will decide when you must stop and when to restart your treatment with

Segluromet.

During treatment with Segluromet, your doctor will check your kidney function at least once a year or

more frequently if you are elderly and/or if you have worsening kidney function.

Foot care

Like for all diabetic patients it is important to check your feet regularly and adhere to any other advice

regarding foot care given by your health care professional.

Urine glucose

Because of how Segluromet works, your urine will test positive for sugar (glucose) while you are on

this medicine.

Children and adolescents

Children and adolescents below 18 years should not take this medicine. It is not known if this

medicine is safe and effective when used in children and adolescents under 18 years of age.

Other medicines and Segluromet

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

You may need more frequent blood glucose and kidney function tests, or your doctor may need to

adjust the dose of Segluromet. In particular, tell your doctor:

if you are taking medicines which increase urine production (diuretics).

if you are taking other medicines that lower the sugar in your blood, such as insulin or

medicines that increase insulin release from the pancreas.

if you are taking medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors,

such as ibuprofen and celecoxib).

if you are taking certain medicines for the treatment of high blood pressure (ACE inhibitors and

angiotensin II receptor antagonists).

If any of the above apply to you (or you are not sure), tell your doctor.

If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for

example, in the context of an X-ray or scan, you must stop taking Segluromet before or at the time of

the injection. Your doctor will decide when you must stop and when to restart your treatment with

Segluromet.

Segluromet with alcohol

Avoid excessive alcohol intake while taking Segluromet since this may increase the risk of lactic

acidosis (see section “Warnings and precautions”).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

It is not known if Segluromet can harm your unborn baby. If you are pregnant, talk with your doctor

about the best way to control your blood sugar while you are pregnant. You should not use Segluromet

if you are pregnant.

It is not known if Segluromet passes into breast milk. Talk with your doctor about the best way to feed

your baby if you take this medicine. You should not use Segluromet if you are breast-feeding.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines. Taking this

medicine in combination with insulin or medicines that increase insulin release from the pancreas can

cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as

shaking, sweating and change in vision, and may affect your ability to drive and use machines. Do not

drive or use any tools or machines if you feel dizzy while taking Segluromet.

3.

How to take Segluromet

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

How much to take

The recommended dose of Segluromet is one tablet twice a day.

The dose of Segluromet that you take will depend on your condition and the amount of

ertugliflozin and metformin needed to control your blood sugar.

Your doctor will prescribe the right dose for you. Do not change your dose unless your doctor

has told you to.

Taking this medicine

Swallow the tablet; if you have difficulties in swallowing the tablet can be broken or crushed.

Take one tablet twice daily. Try to take it at the same time each day; this will help you

remember to take it.

It is best to take your tablet with a meal. This will lower your chance of having an upset

stomach.

You need to keep following your food and exercise plan while taking Segluromet.

If you take more Segluromet than you should

If you take too much Segluromet, talk to a doctor or pharmacist straight away.

If you forget to take Segluromet

If you forget a dose, take it as soon as you remember. However, if it is nearly time for your next dose,

skip the missed dose and go back to your regular schedule.

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Segluromet

Do not stop taking this medicine without talking to your doctor. Your blood sugar levels may increase

if you stop the medicine.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a doctor or the nearest hospital straight away if you have any of the following serious

side effects:

Lactic acidosis (very rare, may affect up to 1 in 10,000 people)

Segluromet may cause a very rare, but very serious side effect called lactic acidosis (see section

“Warnings and precautions”). If this happens, you must stop taking Segluromet and contact a doctor or

the nearest hospital immediately, as lactic acidosis may lead to coma.

Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people)

These are the signs of diabetic ketoacidosis (see also section “Warnings and precautions”):

increased levels of “ketone bodies” in your urine or blood

rapid weight loss

feeling sick or being sick

stomach pain

excessive thirst

fast and deep breathing

confusion

unusual sleepiness or tiredness

a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your

urine or sweat

This may occur regardless of blood glucose level. Your doctor may decide to temporarily or

permanently stop your treatment with Segluromet.

If you notice any of the side effects above, contact a doctor or the nearest hospital straight away.

Contact your doctor as soon as possible if you notice the following side effects:

Dehydration (losing too much water from your body; common, may affect up to 1 in 10 people)

Symptoms of dehydration include:

dry mouth

feeling dizzy, light-headed, or weak, especially when you stand up

fainting

You may be more likely to get dehydrated if you:

have kidney problems

take medicines that increase your urine production (diuretics) or lower blood pressure

are 65 years or older

Low blood sugar (hypoglycaemia; common)

Your doctor will tell you how to treat low blood sugar and what to do if you have any of the symptoms

or signs below. The doctor may lower the dose of your insulin or other diabetes medicine.

Signs and symptoms of low blood sugar may include:

headache

drowsiness

irritability

hunger

dizziness

confusion

sweating

feeling jittery

weakness

fast heart beat

If you notice any of the side effects above, contact your doctor as soon as possible.

Other side effects include:

Very common

vaginal yeast infection (thrush)

feeling sick (nausea)

vomiting

diarrhoea

stomach ache

loss of appetite

Common

yeast infections of the penis

changes in urination, including urgent need to urinate more often, in larger amounts, or at night

thirst

vaginal itching

change in taste

blood tests may show changes in the amount of urea in your blood

blood tests may show changes in the amount of total and bad cholesterol (called LDL - a type of

fat in your blood)

blood tests may show changes in the amount of red blood cells in your blood (called

haemoglobin)

Uncommon (may affect up to 1 in 100 people)

blood tests may show changes related to kidney function (such as ‘creatinine’)

painful urination

Very rare

decreased vitamin B

levels. This may cause anaemia (low levels of red blood cells).

liver function test disorders

hepatitis (a liver problem)

hives

redness of the skin

itching

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects directly via the national reporting

system listed in Appendix V. By reporting side effects you can help provide more information on the

safety of this medicine.

5.

How to store Segluromet

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use this medicine if the packaging is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Segluromet contains

The active substances are ertugliflozin and metformin.

Each Segluromet 2.5 mg/850 mg film-coated tablet contains 2.5 mg ertugliflozin (as

ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.

Each Segluromet 2.5 mg/1,000 mg film-coated tablet contains 2.5 mg ertugliflozin (as

ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.

Each Segluromet 7.5 mg/850 mg film-coated tablet contains 7.5 mg ertugliflozin (as

ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.

Each Segluromet 7.5 mg/1,000 mg film-coated tablet contains 7.5 mg ertugliflozin (as

ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride.

The other ingredients are:

Tablet core: povidone (E1201), microcrystalline cellulose (E460), crospovidone (E1202),

sodium lauryl sulfate (E487), magnesium stearate (E470b).

Film coating:

Segluromet 2.5 mg/850 mg tablets and Segluromet 7.5 mg/850 mg tablets: hypromellose

(E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), iron oxide red (E172),

iron oxide yellow (E172), iron oxide black (E172), carnauba wax (E903).

Segluromet 2.5 mg/1,000 mg tablets and Segluromet 7.5 mg/1,000 mg tablets:

hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), iron

oxide red (E172), carnauba wax (E903).

What Segluromet looks like and contents of the pack

Segluromet 2.5 mg/850 mg film-coated tablets (tablets) are beige, 18 x 10 mm oval, film-coated

tablets debossed with “2.5/850” on one side and plain on the other side.

Segluromet 2.5 mg/1,000 mg film-coated tablets (tablets) are pink, 19.1 x 10.6 mm oval,

film-coated tablets debossed with “2.5/1000” on one side and plain on the other side.

Segluromet 7.5 mg/850 mg film-coated tablets (tablets) are dark brown, 18 x 10 mm oval,

film-coated tablets debossed with “7.5/850” on one side and plain on the other side.

Segluromet 7.5 mg/1,000 mg film-coated tablets (tablets) are red, 19.1 x 10.6 mm oval,

film-coated tablets debossed with “7.5/1000” on one side and plain on the other side.

Segluromet is available in Alu/PVC/PA/Alu blisters. The pack sizes are 14, 28, 56, 60, 168, and

180 film-coated tablets in non-perforated blisters, multipack containing 196 (4 packs of 49) film

coated tablets in non-perforated blisters and 30x1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

Merck Sharp & Dohme Ltd.

Merck Sharp & Dohme BV

Hertford Road, Hoddesdon

Waarderweg 39

Hertfordshire

2031 BN, Haarlem

EN11 9BU

Netherlands

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

MSD Belgium BVBA/SPRL

Tél/Tel: 0800 38 693 (+32(0)27766211)

dpoc_belux@merck.com

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Teл.: + 359 2 819 3737

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Tél/Tel: +32(0)27766211

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Česká republika

Merck Sharp & Dohme s.r.o.

Tel.: +420 233 010 111

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Tel.: + 36 1 888-5300

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malta_info@merck.com

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e-mail@msd.de

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medicalinfo.nl@merck.com

Eesti

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Tel: + 372 6144 200

msdeesti@merck.com

Norge

MSD (Norge) AS

Tlf: + 47 32 20 73 00

msdnorge@msd.no

Ελλάδα

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Τηλ: + 30 210 98 97 300

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MSD France

Tél: + 33 (0) 1 80 46 40 40

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Tel: + 351 21 4465700

clic@merck.com

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croatia_info@merck.com

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Merck Sharp & Dohme Ireland (Human Health)

Limited

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medinfo_ireland@merck.com

Slovenija

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d.o.o.

Tel: + 386 1 5204201

msd_slovenia@merck.com

Ísland

Vistor hf.

Sími: + 354 535 7000

Slovenská republika

Merck Sharp & Dohme, s.r.o.

Tel: + 421 (2) 58282010

dpoc_czechslovak@merck.com

Italia

MSD Italia S.r.l.

Tel: +39 06 361911

medicalinformation.it@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: + 358 (0)9 804650

info@msd.fi

Κύπρος

Merck Sharp & Dohme Cyprus Limited

Τηλ: 800 00 673

+357 22866700

cyprus_info@merck.com

Sverige

Merck Sharp & Dohme (Sweden) AB

Tfn: + 46 (0)77 570 04 88

medicinskinfo@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija

Tel: + 371 67 364224

msd_lv@merck.com

United Kingdom

Merck Sharp & Dohme Limited

Tel: +44 (0) 1992 467272

medicalinformationuk@merck.com

This leaflet was last revised in {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

12-12-2018


Metformin: List of nationally authorised medicinal products - PSUSA/00002001/201804

Metformin: List of nationally authorised medicinal products - PSUSA/00002001/201804

Metformin: List of nationally authorised medicinal products - PSUSA/00002001/201804

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

14-11-2018

Ebymect (AstraZeneca AB)

Ebymect (AstraZeneca AB)

Ebymect (Active substance: dapagliflozin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)7605 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4162/WS/1380

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Xigduo (AstraZeneca AB)

Xigduo (AstraZeneca AB)

Xigduo (Active substance: dapagliflozin/metformin) - Centralised - Renewal - Commission Decision (2018)6462 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2672/R/44

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

30-8-2018

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Active substance: ertugliflozin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5789 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4315/T/2

Europe -DG Health and Food Safety

27-8-2018

Steglujan (Merck Sharp and Dohme B.V.)

Steglujan (Merck Sharp and Dohme B.V.)

Steglujan (Active substance: ertugliflozin / sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5698 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4313T/04

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Active substance: canagliflozin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)3463 of Wed, 30 May 2018

Europe -DG Health and Food Safety