Amitrip

Main information

  • Trade name:
  • Amitrip 10 mg Film coated tablet
  • Dosage:
  • 10 mg
  • Pharmaceutical form:
  • Film coated tablet
  • Units in package:
  • Blister pack, PVC/Al, 100's, 100 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Dipharma Francis Srl

Documents

Localization

  • Available in:
  • Amitrip 10 mg Film coated tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • AMITRIP is recommended for the treatment of depression.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 3280
  • Authorization date:
  • 14-07-1983
  • Last update:
  • 27-09-2017

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

Page 1 of 3

NEW ZEALAND CONSUMER MEDICINE INFORMATION

AMITRIP

Amitriptyline hydrochloride film coated tablets 25 mg & 50 mg

What is in this leaflet

This leaflet answers some common

questions about AMITRIP. It does

not contain all the information

available on this medicine. 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

using AMITRIP against the benefits

expected it will have for you. If you

have any concerns about using this

medicine, ask your doctor or

pharmacist.

Keep this leaflet. You may want to

read it again.

What AMITRIP is

used for and how it

works

Your AMITRIP tablets contain

amitriptyline hydrochloride. It

belongs to a group of medicines

known as tricyclic antidepressants

(TCAs).

AMITRIP is used to treat

depression. Depression is thought

to be caused by a chemical

imbalance in parts of the brain.

This affects your whole body and

can cause emotional and physical

symptoms such as feeling low in

spirit, loss of interest in activities,

being unable to enjoy life, poor

appetite or overeating, disturbed

sleep, often waking up early, loss of

sex drive, lack of energy and feeling

guilty over nothing. AMITRIP works

by correcting this chemical

imbalance and may help relieve the

symptoms of depression.

Your doctor may, however,

prescribe AMITRIP for another

reason. Ask your doctor if you have

any questions about why AMITRIP

has been prescribed for you.

AMITRIP is not recommended for

use in children 12 years of age

and under. AMITRIP is not

recommended for use in

adolescents (13-18 years of age)

for the treatment of depression,

unless under the supervision of a

specialist.

AMITRIP is available on

prescription from your doctor.

Before you take

AMITRIP

When you must not take

it

Do not take AMITRIP if:

You are allergic to

amitriptyline, other tricyclic

antidepressants or any other

ingredients listed at the end of

this leaflet

You are taking another

medicine for depression

called a monoamine oxidase

inhibitor (MAOI) or have been

taking a MAOI within the last

14 days. Ask your doctor or

pharmacist if you are unsure

as to whether or not you are

taking a MAOI

You have recently had a heart

attack.

Symptoms of an allergic reaction

may include shortness of breath,

wheezing or difficulty breathing;

swelling of the face, lips, tongue or

other parts of the body; rash, itching

or hives on the skin.

Before you take it

Tell your doctor if:

You have had an allergic

reaction to any medicine that

you have taken previously to

treat your current condition

You have heart, kidney or liver

problems

You have difficulty passing urine

You have epilepsy, fits or

convulsions (or a condition such

as alcoholism, brain damage or

a recent head injury which might

make fits more likely to occur)

You are having electrical shock

treatment

You are pregnant, plan to

become pregnant or are

breastfeeding

You suffer from an overactive

thyroid gland (hyperthyroidism)

or are receiving thyroid

medication

You suffer from raised pressure

in the eye (glaucoma)

You have suicidal thoughts or

have attempted suicide in the

past

You suffer from mania (mood of

excitement, over-activity and

uninhibited behaviour) or bipolar

disorder

You have allergies to any other

medicines, foods, preservatives

or dyes.

If you are pregnant or plan to

become pregnant you need to

discuss with your doctor the risks

and benefits of taking amitriptyline

during pregnancy. The general

condition of your newborn baby

might be affected by the medicine. If

your baby has been exposed to this

medicine during the last three

months of pregnancy it may suffer

withdrawal symptoms such as

trouble with breathing, fits, feeding

difficulties, vomiting, stiff or floppy

muscles, vivid reflexes, tremor,

jitteriness, irritability, constant

crying, and sleepiness. If your

newborn baby has any of these

symptoms, please contact your

doctor immediately.

Taking other medicines

If you are taking any other

medicines, including any you get

without a prescription from a

pharmacy, supermarket or health

food shop, tell your doctor or

pharmacist.

Page 2 of 3

Medicines that may interfere with

AMITRIP include:

Monoamine Oxidase Inhibitors

(e.g. moclobemide, phenelzine,

tranylcypromine)

Other antidepressants (e.g.

SSRIs and tricyclic

antidepressants)

Guanethidine (used to lower

blood pressure)

Sympathomimetics, such as

nasal decongestants (used for

colds or hay fever) and

anticholinergic medicines

Cimetidine (used to treat ulcers

and other stomach complaints)

Central Nervous System

Depressants (e.g. barbiturates)

Disulfiram (used in the

treatment of chronic alcohol

dependence).

These medicines may be affected

by AMITRIP or may affect how well

AMITRIP works. You may need

different amounts of your medicines

or you may need to take different

medicines.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while taking

AMITRIP.

How to take AMITRIP

properly

How much to take

Your doctor will tell you how much

AMITRIP you need to take each

day. It is important that you take

AMITRIP as directed by your

doctor. Do not take more than the

recommended dose.

It may take up to 4 weeks before

any response to AMITRIP is

noticeable.

The usual dose for an adult is 75mg

of amitriptyline a day in divided

doses. If necessary, your doctor

may increase the dose up to a

maximum of 150mg a day.

Alternatively, your doctor may start

you on a daily dose of 50-100mg

and increase the dose by 25-50mg,

if necessary, up to a maximum of

150mg a day. The usual

maintenance dose is 50 to 100mg

per day.

Your doctor may tell you to take

different doses to these. If so, follow

their instructions.

The tablet(s) should be swallowed

whole with a glass of water.

How long to take it

For depression, the treatment is

usually continued for at least six

months to prevent potential

recurrence. You may not feel better

immediately as most

antidepressants take time to work.

Do not stop taking AMITRIP even if

you begin to feel better, unless your

doctor tells you to do so. Make sure

you do not run out of tablets.

If you forget a dose

If you forget a dose, just take the

next dose when it is due. Do not

take more than one dose at a time

to make up for missed doses.

Taking your medicine at the same

time each day may help you to

remember to take it regularly. If you

have trouble remembering to take

your medicine, ask your pharmacist

for some hints.

While you are taking

AMITRIP

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking AMITRIP.

Tell your doctor or pharmacist that

you are taking AMITRIP before you

start any new medicine.

Tell your doctor if you develop a

skin rash or hives, or you become

pregnant while taking AMITRIP.

If you are going to have surgery, tell

the surgeon or anaesthetist that you

are taking AMITRIP.

If you are going to have any blood

tests, tell your doctor that you are

taking AMITRIP.

Keep all appointments you and your

doctor have scheduled so that your

progress can be followed.

Tell your doctor if you notice any of

the following, especially if they are

severe, abrupt in onset, or were not

part of your presenting symptoms:

anxiety, agitation, panic attacks,

insomnia (difficulty sleeping),

irritability, hostility (aggressiveness),

impulsivity, akathisia (restlessness

or difficulty sitting still), hypomania,

mania (mood of excitement, over-

activity and uninhibited behaviour),

worsening of depression.

Tell your doctor immediately if

you have any distressing

thoughts (thought of suicide or

self-harm) or experiences during

this initial period or at any other

time.

Do not take AMITRIP to treat any

other complaints unless your doctor

tells you to.

Do not stop taking AMITRIP or

lower the dose without first checking

with your doctor.

Do not give this medicine to anyone

else, even if their symptoms seem

similar to yours.

AMITRIP may cause drowsiness in

some people. Be careful when

driving, operating machinery or

performing jobs that need you to be

alert, until you are certain that

AMITRIP does not affect your

performance.

Your doctor may suggest avoiding

alcohol while you are being treated

for depression.

Side effects

Tell your pharmacist or doctor as

soon as possible if you do not feel

well while you are taking AMITRIP.

All medicines can have some

unwanted 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.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

Stomach or bowel problems

(e.g. nausea, diarrhoea,

constipation)

Drowsiness

Dry mouth or taste change

Increased sweating

Page 3 of 3

Loss of appetite

Shakiness or tremor

Ejaculation disorders or changes

in your sex drive

Dizziness

Headache

Weakness

Impaired concentration or

thought processes

Trouble sleeping

Vision problems

Irregular heart beats, also called

palpitations

Increased risk of bone fractures.

These are the more common side

effects of AMITRIP.

Tell your doctor immediately if

you:

Develop a rash or hives while

taking AMITRIP.

This side effect is rare but

serious. You may need urgent

medical attention.

See your doctor if you experience

any of the following when you stop

AMITRIP treatment:

Nausea

Headache

Malaise (a general feeling

of being unwell)

Trouble sleeping.

These symptoms are generally not

serious and disappear within a few

days.

The list of side effects mentioned

above is not complete. If you

should suffer from any of these side

effects or any other undesired effect

please tell your doctor or

pharmacist.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

In case of overdose

You should only take the number of

tablets that you have been told.

Immediately contact your doctor

or the National Poisons

Information Centre (0800 POISON

or 0800 764 766) or go to the

Emergency department at your

nearest hospital, if you think that

you may have taken too much, or

if anyone else has taken any

AMITRIP by mistake. Do this

even if there are no signs of

discomfort or poisoning. You

may need urgent medical

attention. Take the pack of

AMITRIP with you if you can.

Keep telephone numbers for these

places handy.

Storage conditions

Do not take this medicine after the

expiry date shown on the

pack/blister strip or if the packaging

shows signs of tampering.

Keep your AMITRIP tablets in the

blister pack until it is time to take

them.

Store below 25°C and out of reach

of children. Avoid exposure to heat,

light and moisture.

Do not store AMITRIP, or any other

medicine, in the bathroom or near a

sink.

Disposal

If your doctor tells you to stop taking

AMITRIP or if the tablets have

passed the expiry date, ask your

pharmacist what to do with the

remaining medicine.

Product Description

What AMITRIP tablets

look like

AMITRIP 25mg tablets are yellow,

film coated biconvex tablets.

AMITRIP 50mg tablets are orange,

film coated biconvex tablets.

AMITRIP tablets are available in

blister packs of 100 or 500 tablets.

Not all pack sizes may be marketed.

Ingredients

AMITRIP 25mg tablets contain

25mg of the active ingredient,

amitriptyline hydrochloride.

AMITRIP 50mg tablets contain

50mg of the active ingredient,

amitriptyline hydrochloride.

Each tablet also contains lactose,

maize starch, disodium edetate,

povidone, pregelatinised maize

starch, colloidal silicon dioxide,

magnesium stearate, contents of a

film coat [diethyl phthalate,

hypromellose, Opaspray yellow

(25mg), Opaspray orange (50mg)]

and carnauba wax.

If you want to know

more

Should you have any questions

regarding this product, please

contact your doctor or pharmacist.

Who supplies this

medicine

Distributed in New Zealand by:

Mylan New Zealand Ltd,

PO Box 11183,

Ellerslie,

Auckland.

Telephone: (09) 579 2792

Date of information

13 May 2014

(Based on datasheet 13 May 2014)

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11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment of maple syrup urine disease, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

4-1-2019


Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Recommendations on eligibility to PRIME scheme -  Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Europe - EMA - European Medicines Agency

14-12-2018


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 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

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

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (Active substance: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate) - Transfer of orphan designation - Commission Decision (2018)8626 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/16/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)8627 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002422

Europe -DG Health and Food Safety

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

10-12-2018

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

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

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

Europe -DG Health and Food Safety

10-12-2018

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Active substance: Mercaptopurine (oral suspension)) - Transfer of orphan designation - Commission Decision (2018)8629 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002301

Europe -DG Health and Food Safety

10-12-2018

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Active substance: Nanoliposomal irinotecan) - Transfer of orphan designation - Commission Decision (2018)8625 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/11/T/02

Europe -DG Health and Food Safety

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

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): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

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

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

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

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

22-11-2018


Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety