CLINDAMYK

Main information

  • Trade name:
  • CLINDAMYK Clindamycin (as hydrochloride) 150 mg capsules blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLINDAMYK Clindamycin (as hydrochloride) 150 mg capsules blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214371
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214371

CLINDAMYK Clindamycin (as hydrochloride) 150 mg capsules blister pack

ARTG entry for

Medicine Registered

Sponsor

Generic Partners Pty Ltd

Postal Address

Level 1 / 313 Burwood Road,Hawthorn, VIC, 3122

Australia

ARTG Start Date

22/08/2014

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. CLINDAMYK Clindamycin (as hydrochloride) 150 mg capsules blister pack

Product Type

Single Medicine Product

Effective date

12/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.

Clindamycin capsules are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci.

Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate.

Anaerobes

Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and skin structure infections; septicaemia;

intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal

gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, non-gonococcal tubo-ovarian abscess, pelvic cellulitis and

post-surgical vaginal cuff infection.

Streptococci

Serious respiratory tract infections; serious skin and skin structure infections, septicaemia.

Staphylococci

Serious respiratory tract infections; serious skin and skin structure infections; septicaemia;

acute haematogenous osteomyelitis.

Pneumococci

Serious respiratory tract infections.

Adjunctive Therapy

In the surgical treatment of chronic bone and joint infections due to susceptible organisms. Indicated surgical procedures should be performed in

conjunction with antibiotic therapy.

Bacteriological studies should be performed to determine the causative organisms and their susceptibility to clindamycin.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

48 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

100 capsules

(S4) Prescription Only Medicine

24 capsules

(S4) Prescription Only Medicine

Components

1. CLINDAMYK Clindamycin (as hydrochloride) 150 mg capsules blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

A hard gelatin capsule, size 1 white/white containing white crystalline

powder, with marking "CLIN 150"

Active Ingredients

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:10:15 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

clindamycin hydrochloride

162.87 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 2 of

Produced at 26.11.2017 at 10:10:15 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

CLINDAMYK

contains the active ingredient (clindamycin hydrochloride)

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about CLINDAMYK

capsules.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking CLINDAMYK

against the benefits expected for you.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What CLINDAMYK

capsules is used for

CLINDAMYK is an antibiotic. It is

used to treat infections in different

parts of the body caused by bacteria.

CLINDAMYK works by killing or

stopping the growth of the bacteria

causing your infection.

CLINDAMYK will not work against

viral infections such as colds or flu.

CLINDAMYK is recommended for

patients who are allergic to penicillin

or patients for whom penicillin is not

suitable.

Your doctor may have prescribed

CLINDAMYK for another reason.

Ask your doctor if you have any

questions about why CLINDAMYK

has been prescribed for you.

This medicine is available only with

a doctor's prescription.

CLINDAMYK is not addictive.

Before you take

CLINDAMYK capsules

When you must not take it

Do not take CLINDAMYK

capsules:

If you have an allergy to:

clindamycin or lincomycin

lactose or any of the other

ingredients listed at the end of

this leaflet (see 'Product

Description').

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 you take it after the expiry date, it

may have no effect at all, or worse,

an entirely unexpected effect.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

You must tell your doctor about all

of the following before you start to

take CLINDAMYK.

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you pregnant or

intend to become pregnant.

Clindamycin crosses the placenta

therefore CLINDAMYK capsules

should only be used in pregnancy if

clearly needed. Your doctor will

discuss the risks and benefits of

taking CLINDAMYK during

pregnancy.

Tell your doctor if you breast-

feeding or intend to breast-feed.

CLINDAMYK capsules are not

recommended during breastfeeding.

Tell your doctor if you have or

have had any of the following

medical conditions:

severe diarrhoea associated with

the use of antibiotics

severe liver disease

severe kidney disease

any gastrointestinal (stomach or

gut) problems

Tell your doctor if you have had

any other health problems or

medical conditions.

If you have not told your doctor or

pharmacist about any of the above,

do so before you start taking

CLINDAMYK capsules.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from a

pharmacy, supermarket or health

food shop.

CLINDAMYK

Some medicines and CLINDAMYK

may interfere with each other. These

include:

erythromycin, an antiobitoic

medicines used for muscle

relaxation in anaesthesia

These medicines may be affected by

CLINDAMYK 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

CLINDAMYK capsules

Follow all directions given to you

by your doctor and pharmacist

carefully.

They may differ from the

information contained in this leaflet.

You may be given a different dosage

depending on your condition and

how you react to the medicine.

If you do not understand the

instructions in this leaflet, ask your

doctor or pharmacist for help.

How much to take

Adults

One (1) capsule (150 mg) every six

hours is the usual dose. The number

of capsules may increase with more

serious infections. Your doctor will

tell you how long to take your

capsules.

Children

CLINDAMYK capsules are not

recommended in children for

formulation reasons.

How to take it

CLINDAMYK capsules should be

taken by mouth, with a full glass of

water.

When to take it

CLINDAMYK can be taken with or

without food, it does not matter.

How long to take it

Your doctor will tell you how long

to take your capsules.

Continue taking CLINDAMYK

until you finish the box or until

your doctor recommends.

Check with your doctor if you are

not sure how long you should be

taking it.

Do not stop taking CLINDAMYK

capsules because you are feeling

better.

If you do not complete the full course

prescribed by your doctor, all of the

bacteria causing your infection may

not be killed. These bacteria may

continue to grow and multiply so that

your infection may not clear

completely or may return.

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 your capsules as you would

normally.

If you are not sure whether to skip

the dose, talk to your doctor or

pharmacist.

Do not take a double dose to make

up for the dose you missed.

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.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) 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 CLINDAMYK. Do

this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

While you are taking

CLINDAMYK capsules

Things you must do

If the symptoms of your infection do

not improve within a few days, or if

they become worse, tell your doctor.

If you get severe diarrhoea, tell

your doctor, pharmacist or nurse

immediately. Do this even if it

occurs several weeks after you

have stopped taking

CLINDAMYK.

Diarrhoea may mean that you have a

serious condition affecting your

bowel. You may need urgent medical

care. Do not take any medicines for

diarrhoea without first checking with

your doctor.

If you get a sore, white mouth or

tongue while taking or soon after

stopping CLINDAMYK, tell your

doctor. Also tell your doctor if you

get vaginal itching or discharge.

This may mean you have a fungal/

yeast infection called thrush.

Sometimes the use of CLINDAMYK

allows fungi/yeast to grow and the

above symptoms to occur.

CLINDAMYK does not work against

fungi/yeast.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

If you are about to start taking any

new medicines, tell your doctor

and pharmacist that you are taking

CLINDAMYK

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking this medicine.

If you feel that CLINDAMYK is not

helping your condition, tell your

doctor.

CLINDAMYK

Tell your doctor if, for any reason,

you have not used CLINDAMYK

exactly as prescribed.

Things you must not do

Do not take CLINDAMYK 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.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

CLINDAMYK.

This medicine helps most people

with treating their infections but it

may have unwanted side effects in

some people.

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

list 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:

oral thrush – white, furry, sore

tongue and mouth

vaginal thrush – sore and itchy

vagina and/or discharge

stomach cramping

stomach discomfort

inflammation of the food pipe;

discomfort or/and pain of the

food pipe

loss or distorted sense of taste

nausea and/or vomiting

heartburn

diarrhoea

loss of appetite

skin rash; severe irritation of the

skin

jaundice (yellowing of the skin)

joint pain and swelling

If any of the following happen

while you are taking

CLINDAMYK capsules or several

weeks after stopping treatment, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

severe stomach cramps;

watery and severe diarrhoea

which may also be bloody;

fever, in combination with one or

both of the above.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

These side effects are very rare.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people.

Do not take any medicine for

diarrhoea without first checking with

your doctor.

Other side effects not listed above

may also occur in some patients. Tell

your doctor if you notice anything

else that is making you feel unwell.

After taking

CLINDAMYK capsules

Storage

Keep your CLINDAMYK capsules

in a cool, dry place where the

temperature stays below 25°C.

If you take the capsules out of their

original container, they may not keep

as well.

Do not store CLINDAMYK

capsules 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

CLINDAMYK capsules consist of a

white cap and white body imprinted

with 'Clin 150' in black printing ink.

Ingredients

CLINDAMYK capsules contain 150

mg of clindamycin (as

hydrochloride).

Also contains the following inactive

ingredients:

lactose

magnesium stearate

maize starch

purified talc

titanium dioxide

gelatin

black printing ink (shellac, iron

oxide black)

Sponsor

Alphapharm Pty Limited

(ABN 93 002 359 739)

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

Phone: (02) 9298 3999

Australian registration numbers:

CLINDAMYK

CLINDAMYK 150 mg: AUST R

214371

This leaflet was prepared on

December 2016.

Clindamyk_cmi\Dec16/00

CLINDAMYK

7-3-2019

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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

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

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

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

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

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

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

Europe -DG Health and Food Safety