Adalat 10

Main information

  • Trade name:
  • Adalat 10 10 mg Modified release tablet
  • Dosage:
  • 10 mg
  • Pharmaceutical form:
  • Modified release tablet
  • Units in package:
  • Blister pack, PA/Al/PVC, PVC/PVDC/Al or PP/Al, 60 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Bayer AG

Documents

Localization

  • Available in:
  • Adalat 10 10 mg Modified release tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Indicated for treatment of coronary heart disease, chronic stable angina pectoris (angina of effort) and hypertension.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 2888
  • Authorization date:
  • 20-12-1984
  • Last update:
  • 27-09-2017

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

New Zealand Consumer Medicine Information

ADALAT ®

(Add·a·lat)

nifedipine

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers somecommon

questions about Adalat tablets. It

does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

This leaflet is for Adalat tablets. It

is different fromthe leaflet for

another formof Adalat known as

Adalat Oros.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Adalat

against the benefits theyexpect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the

medicine.

You mayneed to read it again.

WHAT ADALAT IS

USED FOR

Adalat tablets are used either to

treat high blood pressure or to

manage a type of angina (chest

pain), known as chronic stable

angina.

Adalat tablets are not used for the

relief of a sudden attack of angina

or to manage unstable angina.

Adalat tablets contain the active

substance nifedipine which belongs

to a group of medicines called

work byopening up blood vessels

in the bodyto lower blood pressure

and improve the supplyof blood

and oxygen to the heart.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor mayhave prescribed it

for another reason.

BEFORE YOU TAKE

ADALAT

When you must not take it

Do not take Adalat if you have an

allergy to:

nifedipine, the active ingredient

in Adalat

anyof the ingredients listed at

the end of this leaflet.

Someofthesymptomsofan

allergic reaction mayinclude:

shortness of breath

wheezing or difficultybreathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin.

Do not take Adalat if you are in

cardiogenic shock (very low blood

pressure due to a failing heart).

Do not take Adalat tablets if you

are taking another medicine

containing the active substance

rifampicin, an antibiotic used to

treat tuberculosis and other

serious infections.

Do not take this medicine in the

first 20 weeks of your pregnancy.

It mayaffect your developing baby

Do not breast-feed if you are

taking this medicine.

The active ingredient in Adalat

passes into breast milk and there is

a possibilitythat your babymaybe

affected.

Do not take this medicine after

the expiry date printed on the

pack and blister.

The expirydate is printed on the

carton and on each blister after

“EXP” (e.g. 11 18 refers to

November 2018). The expirydate

refers to the last dayof that month.

If it has expired return it to your

pharmacist for disposal.

Do not take this medicine if the

packaging is torn or shows signs

of tampering.

If the packaging is damaged, return

it to your pharmacist for disposal.

Do not take tablets that show visible

signs of deterioration (e.g. are

broken or discoloured).

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

heart failure

other heart or blood vessel

disorders

low blood pressure

stroke

mini-stroke (also known as

TIA or transient ischaemic

attack)

liver disease

If you have not told your doctor

about any of the above, tell

him/her before you start taking

Adalat.

Adalat contains lactose.

If you have been told byyour

doctor that you have intolerance to

somesugars, tell your doctor before

taking it.

Tell your doctor if you eat

grapefruit or drink grapefruit

juice regularly, including in the

last 3 days before starting Adalat.

You should not have grapefruit

while you are taking Adalat because

this can cause unwanted changes in

the blood pressure lowering effect

of the tablets.

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.

Somemedicines and Adalat may

interfere with each other. Examples

are given below but this is not a

complete list. Talk to your doctor or

pharmacist if you have any

questions.

Medicines to be careful with or

avoid while taking Adalat include:

beta-blockers, e.g. metoprolol,

atenolol

other medicines used to treat

high blood pressure or angina

medicines used to treat

arrhythmia (fast or irregular

heartbeats), e.g. quinidine

other medicines used to treat

somemedicines used to treat

stomach ulcers and heartburn,

e.g. cimetidine, cisapride

rifampicin, used to treat

tuberculosis and other serious

infections

other medicines used to treat

bacterial infections, e.g.

erythromycin, quinupristin,

dalfopristin

medicines used to treat fungal

infections, e.g. ketoconazole

medicines used to treat HIV,

e.g. ritonavir

medicines used to treat

epilepsy,e.g. phenytoin,

carbamazepine, valproic acid,

phenobarbitone

anti-depressants, e.g. fluoxetine,

nefazodone

tacrolimus, used to prevent

rejection after organ transplant

These medicines may be affected

by Adalat or may affect how well

it works. You may need to take

different amounts of your

medicine or you may need to take

different medicines.

Your doctor or pharmacist has a

more complete list of medicines to

avoid while taking Adalat.

HOW TO TAKE ADALAT

Follow all directions given to you

by your doctor or pharmacist

carefully.

Theymaydiffer fromthe

information contained in this leaflet.

If you do not understand the

instructions printed on the

pharmacist label, ask your doctor

or pharmacist for help.

How much to take

The correct dose of Adalat to take

has been decided byyour doctor.

instructions given to you byyour

doctor.

The usual dosage is 10 mgto 20 mg

twice daily. Your doctor may

increase the dose if required.

How to take it

Swallow the tablets whole with

someliquid, either with or without a

meal. Do not break or chew the

tablets.

When to take it

The tablets are usuallytaken every

12 hours.

How long to take it

Your doctor will determine how

long you should take Adalat tablets.

Do not stop taking the tablets unless

you are told to do so byyour

doctor.

If you forget to take it

If you have forgotten to take your

Adalat tablet(s) at the right time,

take it as soon as you remember,

then continue as normal for the next

dose. If you do not remember until

it is almost time to take your next

dose [i.e. within 6 (six) hours of

your next dose], then skip the dose

that you forgot but be sure to take

the next dose when it is due.

Do NOT take a double dose to

make up for the dose you missed.

If you have missed several doses,

consult your doctor.

If you take too much

(overdose)

Immediately telephone your

doctor or Poisons Information

Centre for advice (New Zealand:

0800 POISON or 0800 764 766),

or go to Accident and Emergency

at your nearest hospital, if you

think that you or anyone elsemay

have taken toomany Adalat

tablets. Do this even if there are

no signs of discomfort or

poisoning.You mayneed urgent

medical attention.

Signs of an overdose include feeling

dizzyand fainting due to drop in

blood pressure, irregular or rapid

heart beats, shortness of breath,

shock and loss of consciousness.

WHILE YOU ARE

TAKING ADALAT

Things you must do

Take Adalat tablets exactly as

told by your doctor.

If you do not follow your doctor’s

instruction, you maynot get control

of your blood pressure or relief

fromyour angina.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Adalat.

Tell your doctor if you continue to

have angina attacks or if they

becomemore frequent while you

are taking Adalat tablets.

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking Adalat

tablets.

The use of Adalat may affect the

results of certain laboratory tests.

If you are about to have anytests,

tell your doctor that you are taking

this medicine.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Things you must not do

Do not give this medicine to anyone

else, even if their symptomsseem

similar to yours.

Do not use it to treat anyother

medical conditions unless your

doctor tells you to.

Do not eat grapefruit or drink

grapefruit juice while you are

taking this medicine.

Grapefruit can cause unwanted

changes in the blood pressure

lowering effect of Adalat.

Do not stop taking your medicine

or lower the dosage without

checking with your doctor.

If you stop taking it suddenly,your

condition mayworsen or you may

have unwanted side effects.

Things to be careful of

Be careful driving or operating

machinery until you know how

Adalat affects you.

Adalat tablets maycause dizziness

or fainting in somepatients,

especiallywhen theyfirst start

taking the medicine, change dose,

or drink alcohol.

If you have angina, be careful not to

overdo physical activities when you

first start taking Adalat. You may

feel better when you start taking it,

but you will need time to improve

your physical fitness.

SIDE EFFECTS

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Adalat.

All medicines have side effects.

Sometimes theyare serious, most of

the time theyare not. In serious

cases, you mayneed medical

attention.

Do not be alarmed by the

following lists of side effects. You

may not experience any of them.

Ask your doctor or pharmacist to

answer anyquestions you may

have.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you.

The list below includes the more

common side effects of your

medicine. Theyare usuallymild and

short-lived.

headache

flushing

constipation

generallyfeeling unwell

general swelling and/or

swelling of the arms, ankles or

legs

Your doctor mayneed to monitor

your liver function, as Adalat can

increase your liver enzymes. You

maynot experience anyspecific

symptoms.

If any of the following happen,

stop taking Adalat and tell your

doctor immediately or go to

Accident and Emergency at your

nearest hospital:

chest pain

rash, itching or hives on the

skin

swelling of the face, lips,

tongue, or other parts of the

body

shortness of breath, wheezing,

or trouble breathing

signs of liver problems such as

yellowing of the skin and/or

eyes (jaundice)

signs of frequent infections

such as fever, severe chills, sore

throat or mouth ulcers

These serious side effects are not

common. If you have these side

effects you mayneed urgent

medical attention.

There have been reports of

purple/brown discolouration of the

skin or redness, flaking and itching

of the skin. Also, it has been

reported for somepeople to develop

a rash or blistering of the skin when

theyare exposed to sunlight.

Tell your doctor if you experience

anyof these symptoms.

In a small number of cases ofin

vitrofertilisation, medicines like

nifedipine appeared to have

interfered with the normal function

of sperm.This effect went away

after the medicine was stopped. In

those men who are taking Adalat

tablets and are repeatedly

unsuccessful in fathering a child by

in vitrofertilisation, the medicine

should be considered as one of the

possible causes if no other

explanation can be found.

Tell your doctor or pharmacist if

you notice anything that is

making you feel unwell.

Other side effects not listed above

mayalso occur in somepeople.

AFTER TAKING

ADALAT

Storage

Keep your tablets in the pack

until it is time to take them.

If you take the tablets out of the

pack theymaynot keep well.

Keep the medicine in a cool dry

place where the temperature stays

below 25°C.

Do not store it or any other

medicine in the bathroom, near a

sink, or on a window-sill.

Do not leave it in the car.Heat and

dampcan destroysomemedicines.

Keep the tablets where children

cannot reach them.

A locked cupboard at least one-and-

a half metres above the ground is a

Disposal

If your doctor tells you to stop

taking Adalat or the expirydate has

passed, ask your pharmacist what to

do with anytablets left over.

PRODUCT

DESCRIPTION

What it looks like

Adalat 10 tablets are round, film-

coated tablets in pink-greycolour

marked with “A 10” on one side

The tablets are supplied in blister

packs of 60’s with each tablet

containing 10 mgof nifedipine.

Adalat 20 tablets are round, film-

coated tablets, pink-greyin colour,

marked with “1 U” on one side and

the BAYER cross on the reverse.

The tablets are supplied in blister

packs of 60’s with each tablet

containing 20 mgof nifedipine.

Ingredients

Active Ingredient:

ADALAT 10 - nifedipine 10 mg

ADALAT 20 - nifedipine 20 mg

Inactive ingredients:

cellulose

maize starch

lactose

polysorbate 80

hypromellose

macrogol 4000

magnesiumstearate

iron oxide red

titaniumdioxide

Supplier

Made in Germanyfor:

Bayer New Zealand Limited

3 Argus Place

Hillcrest, North Shore

Auckland 0627

Date of preparation

See MEDSAFE website

www.medsafe.govt.nz ) for latest

New Zealand Consumer Medicine

Information.

® Registered Trademark of Bayer

AG, Germany

© Bayer Australia Ltd

All rights reserved

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Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

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

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

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

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

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

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

Europe -DG Health and Food Safety