3TC

Main information

  • Trade name:
  • 3TC 10 mg/mL Oral solution
  • Dosage:
  • 10 mg/mL
  • Pharmaceutical form:
  • Oral solution
  • Units in package:
  • Bottle, plastic, 240 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Mylan Laboratories Limited

Documents

Localization

  • Available in:
  • 3TC 10 mg/mL Oral solution
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • 3TC in combination with other anti-retroviral agents is indicated for the treatment of HIV infected adults and children.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 7597
  • Authorization date:
  • 04-08-1995
  • Last update:
  • 09-05-2018

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

3TC

®

Lamivudine tablets 150 mg, oral solution 10 mg/mL

___________________________________________________________________________________________________

Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully

before you start taking 3TC tablets

or oral solution.

This leaflet answers some common

questions about 3TC. It does not

contain all of the available

information.

It does not take the place of talking

to your doctor or pharmacist.

What 3TC is used for

3TC contains the active ingredient

lamivudine, which belongs to a

group of medicines called

antiretrovirals.

Please note that the active ingredient

in 3TC, lamivudine, is also available

as a combination medicine,

Combivir

, containing another

antiretroviral medicine called

zidovudine.

3TC is used, in combination with

other antiretrovirals, for the

treatment of HIV infected adults and

children.

3TC does not cure AIDS or HIV

infection, but slows down

production of human

immunodeficiency virus. In this way

it stops ongoing damage to the

body’s immune system, which

fights infection.

3TC does not reduce your risk of

passing HIV infection to others.

You will still be able to pass on the

HIV virus by sexual activity or by

passing on blood or body secretions

which carry the HIV virus. You

should continue to take all the

appropriate precautions.

While taking 3TC and/or any other

therapy for HIV disease, you may

continue to develop further

infections and other complications

of HIV disease. You should keep in

regular contact with your doctor.

The long term risks and benefits of

taking 3TC are not known.

Your doctor may have prescribed

3TC for another reason. Ask your

doctor if you have any questions

about why 3TC has been prescribed

for you.

3TC is not addictive.

Before you take 3TC

When you must not take

it

Do not take 3TC tablets or oral

solution if you have ever had an

allergic (hypersensitivity)

reaction to lamivudine alone

(3TC) or in combination with

another antiretroviral medicine

called zidovudine (Combivir),

or to zidovudine alone

(Retrovir

Do not take 3TC tablets or oral

solution if you have ever had an

allergic reaction to any of the

other ingredients in 3TC listed

at the end of this leaflet.

Do not take 3TC tablets or oral

solution if you are pregnant,

trying to become pregnant or

breastfeeding, unless your

doctor says you should.

Your doctor may discuss with you

the risks and benefits of taking 3TC

if you are pregnant or breastfeeding.

If you have certain health

conditions, your doctor may advise

that you take a lower dose of 3TC.

Ask your doctor if you are not sure

whether you should take 3TC.

Do not take 3TC tablets or oral

solution after the expiry date

(EXP) on the packaging. If you

take them after the expiry date

has passed they may not work

as well.

Do not take 3TC tablets or oral

solution if the packaging is torn

or shows signs of tampering, if

the tablets look discoloured or

damaged, or if the oral solution

looks lumpy or discoloured.

If you’re not sure whether you

should be taking 3TC tablets or oral

solution, talk to your doctor.

Before you start to

take 3TC

You must tell your doctor

if:

You are allergic to any foods,

dyes, preservatives or any other

medicines.

You are taking or have recently

taken any other medicines.

You have, or ever have had,

hepatitis B virus (HBV)

infection.

You have, or ever have had,

liver problems.

You have kidney disease.

You have pancreatitis

(inflammation of the pancreas)

You have diabetes; an adult

dose of 3TC oral solution

contains 3g of sucrose.

When you stop taking

3TC

If you have a long-standing viral

infection of your liver called

hepatitis B, it may flare up when

you stop taking 3TC. This can cause

serious illness, particularly if your

liver is already not working very

well. If you have both HIV and

hepatitis B virus, when you stop

taking your 3TC tablets or oral

solution, your doctor is likely to

arrange tests from time to time to

check how well your liver is

working and to measure your virus

levels.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

medicines you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Tell your doctor if you are taking an

antibacterial (antibiotic) medicine

called trimethoprim (Triprim

used for urinary tract infection.

Trimethoprim is also used in

combination with another

antibacterial medicine called

sulphamethoxazole (co-trimoxazole,

also known as Bactrim

Septrin

, Trimel

, Trisul

) used

to treat Pneumocystis jiroveci lung

infection (often referred to as PCP).

Tell your doctor if you are taking

zalcitabine or emtricitabine.

Tell your doctor if you are regularly

taking sorbitol-containing medicines

(usually liquids).

Your doctor or pharmacist will be

able to tell you what to do when

taking 3TC tablets or oral solution

with other medicines.

Use in children

3TC can be used in children. The

3TC oral solution is particularly

suitable for younger children.

How to take 3TC

Your doctor will tell you how many

3TC tablets or how much 3TC oral

solution to take and how often.

You will also find this information

on the labelling of your medicine.

Do not take or give extra 3TC

tablets or oral solution. Do not take

3TC or any medicine more often

than you have been told.

How much to take

3TC Tablets:

For adults, adolescents and children

weighing at least 25 kg:

The usual dose is 300 mg of

lamivudine daily. This can be taken

as one, 150 mg tablet twice daily or

two 150 mg tablets, once daily.

For children weighing at least 20 kg

and less than 25 kg:

The usual dose is 225 mg of

lamivudine daily. This may be taken

as either one-half of a 150 mg

scored tablet (75 mg) in the morning

and one whole 150 mg tablet in the

evening, or one and a half 150 mg

scored tablets (225 mg) once daily.

Children weighing at least 14 and

less than 20 kg:

The usual dose is 150 mg

lamivudine daily. This may be

administered as either one half of a

150 mg scored tablet (75 mg) twice

daily or one while 150 mg tablet

once daily.

3TC oral solution:

For adults, adolescents and children

weighing at least 25 kg:

The usual dose is 300 mg (30 mL)

lamivudine daily. This may be

administered as either 150 mg

(15 mL) twice daily or 300 mg

(30 mL) once daily.

For children aged at least three

months and weighing less than 25

The usual dose is 4 mg per kilogram

of body weight twice daily or 8 mg

per kilogram once daily, up to a

maximum of 300 mg daily. The

daily dose of 3TC will be calculated

by your child’s doctor.

The recommended dose for 3TC is

reduced in people with kidney

disease and depends on how well

their kidneys are working.

How to take it

3TC tablets should be swallowed

with a drink of water.

3TC oral solution should be

swallowed from a spoon able to

measure 15 ml of fluid.

3TC tablets and oral solution can be

taken with or without food.

How long to take it

Because your medicine helps to

control your condition but does not

cure it, you will need to take 3TC

every day. Do not stop taking your

medicine without first talking to

your doctor.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to. Otherwise, take it as soon

as you remember, then go back to

taking it as you would normally.

Do not take a double dose to make

up for the one that you missed.

If you take too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre (0800

POISON, 0800 764 766) or go to

the accident and emergency

department at your nearest hospital,

if you think that you or anyone else

may have taken too much 3TC. Do

this even if there are no signs of

poisoning or discomfort. You may

need urgent medical attention.

Keep telephone numbers for these

places handy.

If you are not sure what to do,

contact your doctor or pharmacist.

While you are taking

3TC

Things you must do

Tell your doctor or pharmacist that

you are taking 3TC tablets or oral

solution if you are about to be

started on any new medicines,

including medicines you buy from a

pharmacy, health food shop or

supermarket.

Tell your doctor if you become

pregnant or are trying to become

pregnant or you are breastfeeding.

Tell your doctor if, for any reason,

you have not taken your medicine

exactly as prescribed. Otherwise

your doctor may think that it is not

working for you and change your

medicine unnecessarily.

Things you must not do

Do not stop taking 3TC tablets or

oral solution, or change the dose,

without first checking with your

doctor.

Do not give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Do not use 3TC tablets or oral

solution to treat any other

complaints unless your doctor says

Things to be careful of

Be careful driving or operating

machinery until you know how

treatment with 3TC affects you. As

with many other medicines, 3TC

tablets and oral solution may cause

headache and tiredness in some

people.

Side-Effects

Check with your doctor as soon as

possible if you have any problems

while taking 3TC tablets or oral

solution, even if you do not think

the problems are connected with the

medicine or are not listed in this

leaflet.

Like many other medicines, 3TC

tablets and oral solution can cause

some side effects. If they occur, they

are most likely to be minor and

temporary. However, some may be

serious and need medical attention.

It is not known whether many of

these side effects are due to taking

3TC alone or taking 3TC while

taking other medicines. Some of

these symptoms may also occur as

part of HIV infection, AIDS or

AIDS-related Complex (ARC).

While you are taking 3TC, it is very

important that your doctor keeps a

close check on your health and takes

blood samples to monitor levels of

red and white blood cells. If you

develop anaemia (a low red cell

count), neutropenia (a low white cell

count) or lactic acidosis (a build up

of lactic acid in the blood) your

doctor may reduce your 3TC dose or

stop treatment with 3TC, and

recommend standard treatment for

these side effects.

Other effects that may show up in a

blood test include increased levels

of sugar and fats (triglycerides and

cholesterol).

Your doctor may also perform tests

to ensure that your liver is working

properly.

Other side effects include:

Nausea (feeling as if you are

about to vomit), vomiting

Bleeding or bruising more

easily than normal

Tiredness, dizziness

Mouth ulcers, sore throat

Pain in the upper abdomen

Diarrhoea

Joint pains

Muscle aches and pains, muscle

spasm, shaking or twitching,

muscle weakness

Headache

Unusual sensations, such as

numbness, burning, tingling, or

“pins and needles”

Skin rash

Hair loss

Fatigue and a general feeling of

“unwellness”

Fever, severe chills

If you think that 3TC is causing you

to have an allergic (hypersensitivity)

reaction, TELL YOUR DOCTOR

IMMEDIATELY.

Symptoms of an allergic reaction

may be mild or severe. They usually

include some or all of the following:

Wheezing

Swelling of the lips/mouth

Difficulty breathing

Hayfever, lumpy rash (“hives”)

and/or fainting.

Ask your doctor or pharmacist if

you have any questions about the

side effects of 3TC tablets or oral

solution.

Tell your doctor if you notice

anything else that is making you feel

unwell, even if it is not on this list.

Ask your doctor or pharmacist if

you don’t understand something on

this list.

Do not be alarmed by this list of

side effects. You may not

experience any of them.

After taking 3TC

Storage

Keep this medicine where young

children cannot reach it. A locked

cupboard at least one and a half

metres off the ground is a good

place to store medicines.

Keep 3TC tablets in a cool, dry

place where the temperature stays

below 30°C.

Keep your 3TC tablets in their pack

until it is time to take them.

If you take 3TC tablets out of their

pack they may not work as well.

Keep 3TC oral solution in a cool,

dry place where the temperature

stays below 25°C.

If you are taking 3TC oral solution,

always screw the lid on the bottle

after taking your medicine,

otherwise it may not work as well.

Discard 3TC oral solution one

month after first opening the bottle.

Disposal

If your doctor tells you to stop

taking 3TC tablets or oral solution,

or your medicine has passed its

expiry date, ask your pharmacist

what to do with any leftover

medicine.

Product description

What 3TC looks like

3TC tablets are white, diamond-

shaped, and engraved with GX CJ7

on one side and 3TC on the other

side. They come in white bottles,

each containing 60 tablets.

3TC oral solution is a colourless to

pale yellow, strawberry and vanilla

flavoured liquid. It comes in a 240

mL white bottle. A 10 mL oral

dosing syringe and an adaptor are

also included in the pack.

Ingredients

3TC tablets

Lamivudine 150 mg,

Microcrystalline cellulose,

Sodium starch glycollate,

Magnesium stearate,

Hydroxypropylmethyl cellulose,

Titanium dioxide, Macrogol

Polysorbate 80

3TC oral solution

Lamivudine 150 mg/10 ml,

Sucrose (20% w/v),

Methylhydroxybenzoate,

Propylhydroxybenzoate,

Citric acid anhydrous,

Propylene glycol, Sodium citrate,

Artificial strawberry flavour,

Artificial banana flavour,

Purified water

Sponsor Details

GlaxoSmithKline NZ Ltd

Private Bag 106600

Downtown

Auckland 1143

New Zealand

Ph: (09) 367 2900

Fax (09) 367 2910

Further information

This is not all the information that is

available on 3TC tablets and oral

solution. If you have any more

questions or are not sure about

anything, ask your doctor or

pharmacist.

Pharmaceutical companies are not in

a position to give people an

individual diagnosis or medical

advice. Your doctor or pharmacist is

the best person to give you advice

on the treatment of your condition.

You may also be able to find

general information about your

disease and its treatment from books

in public libraries, or on the Internet.

Date of Preparation

This leaflet was prepared on:

31 January 2017

3TC, Retrovir and Combivir are

registered trade marks of the GSK

group of companies.

© 2017 GSK group of companies.

All rights reserved.

Version 6.0

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Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

21-11-2018

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

11-1-2019


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

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): lamivudine,dolutegravir, decision type: , therapeutic area: , PIP number: P/0151/2018

Opinion/decision on a Paediatric investigation plan (PIP): lamivudine,dolutegravir, decision type: , therapeutic area: , PIP number: P/0151/2018

Opinion/decision on a Paediatric investigation plan (PIP): lamivudine,dolutegravir, decision type: , therapeutic area: , PIP number: P/0151/2018

Europe - EMA - European Medicines Agency

28-11-2018

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (Active substance: Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8044 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/242/T/73

Europe -DG Health and Food Safety

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

Delstrigo (Merck Sharp and Dohme B.V.)

Delstrigo (Merck Sharp and Dohme B.V.)

Delstrigo (Active substance: doravirine / lamivudine / tenofovir disoproxil) - Centralised - Authorisation - Commission Decision (2018)7960 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004746

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

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

18-10-2018

Kivexa (ViiV Healthcare BV)

Kivexa (ViiV Healthcare BV)

Kivexa (Active substance: abacavir / Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6924 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000581/T/0076

Europe -DG Health and Food Safety