RANITIDINE

Main information

  • Trade name:
  • RANITIDINE GH ranitidine (as hydrochloride) 300 mg film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RANITIDINE GH ranitidine (as hydrochloride) 300 mg film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219142
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219142

RANITIDINE GH ranitidine (as hydrochloride) 300 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

19/09/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. RANITIDINE GH ranitidine (as hydrochloride) 300 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

16/05/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Short-term treatment of proven duodenal ulcer and gastric ulcer.

Maintenance treatment to reduce the risk of relapse in duodenal ulcer.

Maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer.

Treatment of gastrinoma (Zollinger-Ellison syndrome).

Short-term symptomatic treatment of reflux oesophagitis unresponsive to conservative antireflux measures and simple drug therapies such as antacids.

Maintenance treatment to reduce the risk of relapse of reflux oesophagitis.

Treatment of scleroderma oesophagitis.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1. RANITIDINE GH ranitidine (as hydrochloride) 300 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Yellow, oblong film-coated tablets scored on one side

Active Ingredients

Ranitidine hydrochloride

335 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:54:45 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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

1311 Ranitidine GH CMI v1

Page 1

CONSUMER MEDICINE INFORMATION

Ranitidine GH

ranitidine hydrochloride film-coated tablets

What is in this leaflet

This leaflet answers some common questions about Ranitidine GH.

It does not contain all the available information. It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risk of you taking this

medicine against the benefits they expect 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 may need to read it again.

What Ranitidine GH is used for

This medicine is used to treat:

Peptic ulcers. Depending on the position of the ulcer it is called a gastric or duodenal

ulcer.

gastric

ulcer

occurs

stomach.

duodenal

ulcer

occurs

duodenum which is the tube leading out of the stomach. These can be caused in

part by too much acid being produced in the stomach. Ranitidine GH is also used to

help stop these ulcers from coming back.

Reflux oesophagitis or reflux disease. This can be caused by “washing back” (reflux)

food

acid

from

stomach

into

food

pipe,

also

known

oesophagus. Reflux can cause a burning sensation in the chest rising up to the

throat, also known as heartburn.

Zollinger-Ellison syndrome, a rare condition where the stomach produces very large

amounts of acid, much more than in ulcers and reflux disease.

Scleroderma

oesophagitis. Scleroderma

is a

rare

condition, and in scleroderma

oesophagitis the food pipe is abnormal and reflux occurs.

contains

active

ingredient

ranitidine

hydrochloride.

Ranitidine

hydrochloride

belongs to a group of medicines called H

antagonists or H

blockers.

It works by decreasing the amount of acid made by the stomach. This helps to reduce

the pain and also allows the ulcer and/or reflux disease to heal in most people.

1311 Ranitidine GH CMI v1

Page 2

Ask

your

doctor

if

you

have

any

questions

about

why

this

medicine

has

been

prescribed for you.

Your doctor may have prescribed it for another reason.

There is no evidence that Ranitidine GH is addictive.

Before you take Ranitidine GH

When you must not take it

Do not take this medicine if you have an allergy to:

ranitidine, the active ingredient, or to any of the other ingredients listed at the end

of this leaflet under Product description

any other similar medicines.

Some of the 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.

Do not take this medicine after the expiry date printed on the pack or if the packaging

is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking 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:

acute porphyria, an inherited blood condition

kidney problems

liver problems

lung disease

diabetes

any condition where your immune system may be affected.

Tell your doctor if you have had to stop taking this or any other medicine for your

ulcer or reflux.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.

Your doctor can discuss with you the risks and benefits involved.

1311 Ranitidine GH CMI v1

Page 3

If you have not told your doctor about any of the above, tell him/her before you start

taking Ranitidine GH.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any

that you get without a prescription from your pharmacy, supermarket or health food

shop.

Some medicines and Ranitidine GH may interfere with each other. These include:

sucralfate, another medicine used to treat ulcers

warfarin, a medicine used to prevent blood clots

triazolam and midazolam, medicines used as sedatives

ketoconazole, an anti-fungal medicine

atazanavir and delavirdine, medicines used to treat HIV

glipizide, a medicine used for diabetics

gefitinib, a medicine used in the treatment of cancer.

These medicines may be affected by Ranitidine GH or may affect how well it works. You

may need different amounts of your medicines, or you may need to take different

medicines.

Your doctor and pharmacist have more information on medicines to be careful with or

avoid while taking this medicine.

How to take Ranitidine GH

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help.

How much to take

The dosage of Ranitidine GH depends on the condition it is being used to treat. The

usual adult dosage range is 150mg to 300mg per day, taken as one 150mg tablet once or

twice

day or one

300mg tablet at bed time. The

treatment

Zollinger-Ellison

syndrome may require higher doses.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take.

Follow the instructions they give you.

If you take the wrong dose, Ranitidine GH may not work as well and your problem may

not improve.

1311 Ranitidine GH CMI v1

Page 4

How to take it

If you need to break Ranitidine GH, hold the tablet with both hands and snap along the

break line.

When to take Ranitidine GH

It does not matter whether you take the tablets before or after food.

How long to take Ranitidine GH

The duration of treatment with Ranitidine GH depends on the condition it is being used

to treat.

Your pain or other symptoms may take a few days to go away. Take all the tablets your

doctor has prescribed for you, even if you feel better.

Your doctor may decide to continue your treatment with Ranitidine GH, possibly at a

different dosage range, in order to prevent the problem from coming back again.

Use in children

Ranitidine

has not

been studied fully

in children. However, it

has been

used

successfully in children aged 8 to 18 years in doses up to 150mg twice daily. Your child’s

doctor will discuss the risks and benefits of your child taking Ranitidine GH.

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would

normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose

when you are meant to.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some

hints.

1311 Ranitidine GH CMI v1

Page 5

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone

Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766) for advice, or go to

Accident and Emergency at the nearest hospital, if you think that you or anyone else

may have taken too much Ranitidine GH. Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical attention.

While you are taking Ranitidine GH

Things you must do

Always follow your doctor’s instructions carefully.

If you are about to be started on any new medicine, remind your doctor and

pharmacist that you are taking Ranitidine GH.

If you become pregnant while taking this medicine, tell your doctor immediately.

Things you must not do

Do not stop taking your medicine or lower the dosage without checking with your

doctor.

Do not take Ranitidine GH to treat any other complaints unless your doctor tells you

to.

Do not give your medicine to anyone else, even if they have the same condition as

you.

Things to be careful of

Be careful driving or operating machinery until you know how Ranitidine GH affects

you.

This medicine may cause dizziness or light-headedness in some people. If you have any

of these symptoms, do not drive, operate machinery or do anything else that could be

dangerous.

Be careful when drinking alcohol while you are taking this medicine.

If you drink, alcohol dizziness or light-headedness may be worse.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are

taking Ranitidine GH.

1311 Ranitidine GH CMI v1

Page 6

All medicines can have side effects. Sometimes they are serious, most of the time they

are not. You may need medical attention if you get some of the side effects.

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 any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

constipation, diarrhoea, nausea (feeling sick) and vomiting

abdominal pain or discomfort.

These are the more common side effects of Ranitidine GH. Mostly, these are mild and

short-lived.

breast tenderness and/or breast enlargement

breast discharge

headache, sometimes severe

hair loss

sexual problems

tiredness or difficulty sleeping

dizziness or drowsiness

muscle and joint pain

abnormal uncontrolled movements, muscle twitching or spasms.

These are rare side effects of Ranitidine GH.

Tell your doctor as soon as possible if you notice any of the following:

yellowing of the skin or eyes (jaundice)

confusion, depression and hallucination

general illness associated with weight loss

blurred vision

skin rash

signs of frequent infections such as fever, chills, sore throat or mouth ulcers

bleeding or bruising more easily than normal.

The above list includes serious side effects that may require medical attention. Serious

side effects are rare.

If any of the following happen, tell your doctor immediately or go to Accident and

Emergency at your nearest hospital:

swelling of the limbs, face, lips, mouth or throat which may cause difficulty in

swallowing or

breathing, itchy rash or hives. These are the symptoms of an allergic

reaction.

1311 Ranitidine GH CMI v1

Page 7

severe upper stomach pain together with nausea and vomiting or a change in the

type of pain wheezing, chest pain or tightness, unusual heart beat (fast, slow or

irregular).

The above list includes very serious side effects. You may need urgent medical attention

or hospitalisation. These side effects are rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel

unwell.

Other side effects not listed above may also occur in some people.

After taking Ranitidine GH

Storage

Keep your medicine in the original container.

If you take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25

Do not store Ranitidine GH or any other medicine in the bathroom or near a sink. Do

not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to

store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask

your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Ranitidine GH 150mg – yellow, round, film-coated tablets, scored on one side. Available

in blisters of 60 tablets.

Ranitidine GH 300mg – yellow, oblong, film-coated tablets, scored on one side. Available

in blisters of 30 tablets.

1311 Ranitidine GH CMI v1

Page 8

Ingredients

Active ingredient:

Ranitidine GH 150mg – 150mg ranitidine as ranitidine hydrochloride

Ranitidine GH 300mg – 300mg ranitidine as ranitidine hydrochloride

Inactive ingredients:

microcrystalline cellulose

calcium hydrogen phosphate

maize starch

sodium starch glycollate type A

magnesium stearate

colloidal anhydrous silica

lactose

hypromellose

titanium dioxide

macrogol 4000

iron oxide yellow.

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Distributor

Generic Health Pty Ltd

Level 1, 1102 Toorak Road

Camberwell VIC 3124

Australia

This leaflet was prepared in November 2013.

Australian Register Numbers

150mg film-coated tablets: AUST R 219141

300mg film-coated tablets: AUST R 219142

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4-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Doxolipad,doxorubicin hydrochloride,  31/01/2019,  Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Europe - EMA - European Medicines Agency

29-1-2019


Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Europe - EMA - European Medicines Agency

28-1-2019

Clomicalm (Elanco GmbH)

Clomicalm (Elanco GmbH)

Clomicalm (Active substance: Clomipramine hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)720 of Mon, 28 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/000039/T/0030

Europe -DG Health and Food Safety

25-1-2019


Ranitidine: List of nationally authorised medicinal products - PSUSA/00002610/201805

Ranitidine: List of nationally authorised medicinal products - PSUSA/00002610/201805

Ranitidine: List of nationally authorised medicinal products - PSUSA/00002610/201805

Europe - EMA - European Medicines Agency

23-1-2019


Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Europe - EMA - European Medicines Agency

22-1-2019


Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

16-1-2019

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Active substance: Benserazide hydrochloride) - Orphan designation - Commission Decision (2019)221 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001719

Europe -DG Health and Food Safety

16-1-2019

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (Active substance: Doxorubicin hydrochloride (in heat-sensitive liposomes)) - Transfer of orphan designation - Commission Decision (2019)237 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003113

Europe -DG Health and Food Safety

16-1-2019

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Active substance: 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride) - Transfer of orphan designation - Commission Decision (2019)236 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003283

Europe -DG Health and Food Safety

11-1-2019


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

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

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

Europe - EMA - European Medicines Agency

13-12-2018


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

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

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

Europe - EMA - European Medicines Agency

13-12-2018


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

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

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

Europe - EMA - European Medicines Agency

11-12-2018


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

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

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

Europe - EMA - European Medicines Agency

28-11-2018


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

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

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

Europe - EMA - European Medicines Agency

28-11-2018


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

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

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

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

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

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 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

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

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

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

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

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

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

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

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

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

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

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

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

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

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

Europe -DG Health and Food Safety