CLINDAMYCIN
Main information
- Trade name:
- CLINDAMYCIN BNM clindamycin (as hydrochloride) 150mg capsule blister pack
- Active ingredient:
- clindamycin hydrochloride
- Available from:
- Boucher & Muir Pty Ltd
- INN (International Name):
- clindamycin hydrochloride
- Medicine domain:
- Humans
- Medicine type:
- Allopathic drug
Documents
- for the general public:
- Patient Information leaflet
-
- for healthcare professionals:
- Summary of Product characteristics
-
- for the general public:
- Public Assessment Report
-
Localization
- Available in:
-
Australia
- Language:
- English
Other information
Status
- Source:
- Dept. of Health,Therapeutic Goods Administration - Australia
- Authorization number:
- 219946
- Last update:
- 08-10-2017
Public Assessment Report
Public Summary
Summary for ARTG Entry:
219946
CLINDAMYCIN BNM clindamycin (as hydrochloride) 150mg capsule blister pack
ARTG entry for
Medicine Registered
Sponsor
Boucher & Muir Pty Ltd
Postal Address
PO Box 333,NORTH SYDNEY, NSW, 2059
Australia
ARTG Start Date
20/03/2015
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. CLINDAMYCIN BNM clindamycin (as hydrochloride) 150mg capsule blister pack
Product Type
Single Medicine Product
Effective date
14/08/2017
Warnings
See Product Information and Consumer Medicine Information for this product
Standard Indications
Specific Indications
Clindamycin BNM (clindamycin hydrochloride) capsules are indicated in the treatment of serious infections caused by susceptible anaerobic
bacteria.,Clindamycin BNM 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/PE/PCTFE
(Aclar)/Al
36 Months
Store below 25
degrees Celsius
Not recorded
Not recorded
Blister Pack
PVC/PE/PVDC/Al
36 Months
Store below 25
degrees Celsius
Not recorded
Not recorded
Pack Size/Poison information
Pack Size
Poison Schedule
100 Capsules
(S4) Prescription Only Medicine
24 Capsules
(S4) Prescription Only Medicine
Components
1. CLINDAMYCIN BNM clindamycin (as hydrochloride) 150mg capsule blister pack
Dosage Form
Capsule, hard
Route of Administration
Oral
Visual Identification
Hard gelatin capsule with purple transparent body and powder blue opaque
cap containing a white/off white powder
Active Ingredients
clindamycin hydrochloride
162.87 mg
Public Summary
Page 1 of
Produced at 26.11.2017 at 03:09:33 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
© 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 03:09:33 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
Clindamycin BNM
19072017
Consumer Medicine Information
Clindamycin BNM
clindamycin (as hydrochloride)
Capsules 150 mg
What is in this leaflet
Please read this leaflet carefully before you start taking Clindamycin BNM.
This leaflet answers some common questions about Clindamycin BNM. It does not contain
all the available information. The most up-to-date Consumer Medicine Information can be
downloaded from www.ebs.tga.gov.au.
Reading this leaflet does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Clindamycin BNM against the benefits this medicine is expected to 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 want to read it again.
What Clindamycin BNM is used for
Clindamycin BNM contains clindamycin, an antibiotic. Clindamycin is used to treat
bacterial infections in different parts of the body.
It works by killing or stopping the growth of the bacteria causing your infection.
Clindamycin BNM will not work against viral infections such as colds or flu.
Clindamycin BNM is recommended for patients who are allergic to penicillin or patients for
whom penicillin is not suitable.
Your doctor may have prescribed this medicine for another reason.
Ask your doctor if you have any questions about why it has been prescribed for
you.
Clindamycin BNM is available only with a doctor's prescription.
Clindamycin BNM is not addictive.
Clindamycin BNM
19072017
Before you take Clindamycin BNM
Clindamycin BNM is not suitable for everyone.
When you must not take it
Do not take Clindamycin BNM if you are allergic to any medicine containing
clindamycin, lincomycin (a very similar antibiotic), or any of the ingredients listed
at the end of this leaflet.
Do not take it after the expiry date (‘EXP’) printed on the pack.
If you take it after the expiry date has passed, it may not work as well.
Do not take it if the packaging is torn or shows signs of tampering.
If you are not sure whether you should start taking this medicine, talk to your doctor
or pharmacist.
Before you start to take it
Tell your doctor or pharmacist if you have allergies to any other medicines, foods,
preservatives or dyes.
Tell your doctor or pharmacist if you have or have had any medical conditions,
especially the following:
diarrhoea, especially severe diarrhoea associated with fever, stomach pain or
cramps, or passage of blood and mucous
a history of gastrointestinal (stomach or gut) problems, particularly colitis
(inflammation of the large bowel)
severe liver or kidney problems
a history of allergies (e.g. asthma, hay fever or eczema)
lactose intolerance.
Tell your doctor if you are over 60 years old.
Diarrhoea and inflammation of the large bowel occur more frequently and may be more
severe if you are over 60 years old.
Tell your doctor if you are pregnant or intend to become pregnant.
Since the active ingredient in Clindamycin BNM crosses the placenta, it should be used in
pregnancy only if clearly needed. Your doctor will discuss the risks and benefits of using it
if you are pregnant.
Do not breast-feed if you are taking this medicine.
The active ingredient in Clindamycin BNM passes into breast milk and there is a possibility
that your baby may be affected.
Do not give Clindamycin BNM to children.
Clindamycin BNM is not recommended in children for formulation reasons.
If you have not told your doctor or pharmacist about any of the above, tell them
before you start taking Clindamycin BNM.
Clindamycin BNM
19072017
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.
Tell any healthcare professional who is prescribing a new medicine for you that you
are taking Clindamycin BNM.
Some medicines and Clindamycin BNM may interfere with each other. These include:
medicines used to relax muscles
erythromycin, an antibiotic (medicine used to treat infections).
If you have bowel problems, do not take opioid pain medicines or medicines for
diarrhoea without first checking with your doctor.
These medicines may make your bowel problems worse.
The above medicines may be affected by Clindamycin BNM, or may affect how well it
works. You may need different amounts of Clindamycin BNM, 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 Clindamycin BNM.
How to take Clindamycin BNM
Read the label carefully and follow all directions given to you by your doctor and
pharmacist.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist
for help.
How much to take
The standard adult dose is one capsule every six hours (i.e. 4 times a day). Your doctor
may increase this dosage for more serious infections.
Clindamycin BNM is not recommended in children for formulation reasons.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take. This depends on your condition and the type
of infection.
If you take the wrong dose, Clindamycin BNM may not work as well and your problem may
not improve.
Clindamycin BNM
19072017
Swallow the capsules whole with a full glass of water and in an upright position.
The content of Clindamycin BNM capsules may irritate your food pipe, therefore it is
important they are swallowed without getting stuck.
When to take it
Take Clindamycin BNM with or without food (it does not matter), every six hours or
as advised by your doctor.
How long to take it
Continue taking the capsules until you finish the pack or until your doctor tells you
to stop. Check with your doctor if you are not sure how long you should be taking
it.
Do not stop taking Clindamycin BNM because you are feeling better.
If you do not complete the full course prescribed by your doctor, some of the bacteria
causing your infection may not be killed. These bacteria may continue to grow and multiply,
so your infection may not clear up completely or it may return.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take the next
dose when you are meant to.
Do not try to make up for missed doses by taking more than one dose at a time.
This may increase the chance of getting an unwanted side effect.
If there is still a long time to go before your next dose, take it as soon as you
remember, and then go back to taking it as you would normally.
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
hints.
While you are taking Clindamycin BNM
Things you must do
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking Clindamycin BNM. Likewise, tell any other doctors, dentists and
pharmacists who are treating you that you are taking this medicine.
Tell your doctor if the symptoms of your infection do not improve within a few days,
or if they become worse.
If you become pregnant while taking this medicine, tell your doctor immediately.
Clindamycin BNM
19072017
If you develop severe diarrhoea, tell your doctor or pharmacist immediately. Do this
even if it occurs several weeks after you have stopped taking Clindamycin BNM. Do
not take any medicines for diarrhoea without first checking with your doctor.
Diarrhoea may mean that you have a serious condition affecting your bowel. You may
need urgent medical care.
Tell your doctor if you get a sore, white mouth or tongue while taking or soon after
stopping Clindamycin BNM. 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
antibiotics allows fungi/yeast to grow and the above symptoms to occur. Clindamycin BNM
does not work against fungi/yeast.
Your doctor may want to carry out liver and kidney function tests or blood counts during
long-term treatment.
Things you must not do
Do not give your medicine to anyone else, even if they have the same condition as
you.
This medicine is only intended for the use of the person it has been prescribed for.
Do not take Clindamycin BNM to treat any other complaints unless your doctor tells
you to.
Things to be careful of
Be careful driving or operating machinery until you know how Clindamycin BNM
affects you.
Make sure you know how you react to it before you drive a car, operate machinery, or do
anything else that could be dangerous.
In case of overdose
If you take too much
Immediately telephone your doctor, or the Poisons Information Centre (telephone
13 11 26), or go to Accident and Emergency at your nearest hospital, if you think
that you or anyone else may have taken too much Clindamycin BNM.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too many capsules, you may notice some of the following signs and symptoms
of overdose:
severe diarrhoea, usually with blood and mucous, stomach pain, fever (symptoms of
pseudomembranous colitis, an inflammation of the large bowel)
skin rash.
Clindamycin BNM
19072017
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Clindamycin BNM.
Like all medicines, Clindamycin BNM may occasionally cause side effects in some people.
Sometimes they are serious, most of the time they are not. You may need medical
attention if you get some of the side effects.
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:
nausea and/or vomiting
itching of the skin
taste disturbance or loss of taste.
These side effects are usually mild.
Tell your doctor or pharmacist if you notice any of the following:
stomach pain or cramping
diarrhoea
inflammation of the food pipe, or ulcers and/or pain in the food pipe
heartburn
skin rash, hives, irritation of the skin
jaundice (yellowing of the skin)
oral thrush (white, furry, sore tongue and/or mouth)
vaginal thrush (discharge and itching in the vagina)
painful or swollen joints.
These may be serious side effects. You may need urgent medical attention.
Tell your doctor immediately if you develop the following symptoms while you are
taking Clindamycin BNM, or several weeks after you have finished taking it:
severe stomach cramps
severe diarrhoea (sometimes with blood and mucous)
fever, in combination with one or both of the above.
These are symptoms of pseudomembranous colitis, an inflammation of the large bowel,
which may require urgent medical care.
Tell your doctor immediately, or go to Accident and Emergency at your nearest
hospital if you notice any of the following:
serious allergic reaction (swelling of the face, lips, mouth or throat which may cause
difficulty in swallowing or breathing)
severe skin reactions accompanied by fever and chills, aching muscles and generally
feeling unwell.
These
very
serious
side
effects;
need
urgent
medical
attention
hospitalisation.
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 patients.
Clindamycin BNM
19072017
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
After taking Clindamycin BNM
Storage
Keep your capsules in the pack until it is time to take them.
If you take the capsules out of the pack they may not keep well.
Keep Clindamycin BNM in a cool dry place where the temperature stays below 25°C.
Do not store it or any other medicine in the bathroom, near a sink, or on a window
sill. Do not leave it in the car.
Heat and damp can destroy some medicines.
Keep it and any other medicine 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.
Do not keep Clindamycin BNM past its expiry date.
Disposal
Return any unused medicine and any medicine past its expiry date (as shown on
the labelling) to your pharmacy.
Product description
What it looks like
Clindamycin BNM is available in blister packs of 24 or 100 capsules. The capsules have a
powder blue opaque cap and a purple transparent body.
Ingredients
Active ingredient:
Clindamycin hydrochloride, equivalent to 150 mg of clindamycin per capsule
Inactive ingredients:
Lactose monohydrate
magnesium stearate
maize starch
purified talc
gelatin
titanium dioxide
carmoisine
indigo carmine
patent blue V.
Clindamycin BNM
19072017
Clindamycin BNM contains lactose.
Clindamycin BNM does not contain sucrose, tartrazine or any other azo dyes.
Sponsor details
Boucher & Muir Pty Ltd
Level 9, 76 Berry Street
North Sydney NSW 2060
AUST R 219946
Date of preparation
This leaflet was prepared on 19 July 2017.
- Access to this document is only available to registered users.
Register now for full access
13-2-2019

Jurnista (hydromorphone hydrochloride) prolonged-release
Product defect correction - potentially damaged tablets
Therapeutic Goods Administration - Australia
1-2-2019

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl
Published on: Thu, 31 Jan 2019 The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic mo...
Europe - EFSA - European Food Safety Authority EFSA Journal
1-2-2019

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM
Published on: Thu, 31 Jan 2019 The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by a genetically modified strain of Corynebacterium glutamicum(NRRL B‐50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. gluta...
Europe - EFSA - European Food Safety Authority EFSA Journal
28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)
Update - medicine shortage
Therapeutic Goods Administration - Australia
24-8-2018

Human medicines European public assessment report (EPAR): Gliolan, 5-aminolevulinic acid hydrochloride, Revision: 4, Authorised
Europe - EMA - European Medicines Agency
21-8-2018

Orphan designation: R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride, for the: Treatment of hereditary angioedema
Europe - EMA - European Medicines Agency
3-8-2018

Human medicines European public assessment report (EPAR): Jentadueto, linagliptin / metformin hydrochloride, Revision: 14, Authorised
Europe - EMA - European Medicines Agency
3-8-2018

Human medicines European public assessment report (EPAR): Ameluz, 5-aminolevulinic acid hydrochloride, Revision: 12, Authorised
Europe - EMA - European Medicines Agency
3-8-2018

Human medicines European public assessment report (EPAR): Ristfor, sitagliptin / metformin hydrochloride, Revision: 18, Authorised
Europe - EMA - European Medicines Agency
1-8-2018

Human medicines European public assessment report (EPAR): Ceplene, histamine dihydrochloride, Revision: 12, Authorised
Europe - EMA - European Medicines Agency
24-7-2018

Opinion/decision on a Paediatric investigation plan (PIP): Palexia and associated names; Yantil and associated names; Tapentadol and associated names, Tapentadol (hydrochloride), Therapeutic area: Pain
Europe - EFSA - European Food Safety Authority EFSA Journal
24-7-2018

Orphan designation: Ambroxol hydrochloride, for the: Treatment of amyotrophic lateral sclerosis
Europe - EMA - European Medicines Agency
5-7-2018

Opinion/decision on a Paediatric investigation plan (PIP): Striverdi, Respimat, Olodaterol (hydrochloride), Therapeutic area: Pneumology-allergology
Europe - EFSA - European Food Safety Authority EFSA Journal
2-7-2018

Human medicines European public assessment report (EPAR): Ristfor, sitagliptin / metformin hydrochloride, Revision: 17, Authorised
Europe - EMA - European Medicines Agency
26-6-2018

Scientific guideline: Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, adopted
Europe - EFSA - European Food Safety Authority EFSA Journal
26-6-2018

Scientific guideline: Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance, adopted
Europe - EFSA - European Food Safety Authority EFSA Journal
19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP): -, Dapagliflozin / saxagliptin / metformin (hydrochloride), Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
Europe - EFSA - European Food Safety Authority EFSA Journal
19-6-2018

Opinion/decision on a Paediatric investigation plan (PIP): -, Trazodone (hydrochloride) / gabapentin, Therapeutic area: Pain
Europe - EFSA - European Food Safety Authority EFSA Journal
5-2-2019

Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018
Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018
Europe - EMA - European Medicines Agency
5-2-2019

Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018
Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018
Europe - EMA - European Medicines Agency
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
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
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
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
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
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
Europe - EMA - European Medicines Agency
28-1-2019

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
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
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
Europe - EMA - European Medicines Agency
16-1-2019

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 (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 (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
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)
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
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
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
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
Europe - EMA - European Medicines Agency
28-11-2018

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](/web/assets/global/img/flags/eu.png)
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
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
Europe - EMA - European Medicines Agency
26-11-2018

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 (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 (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 (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 (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 (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 (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018
Europe -DG Health and Food Safety
18-9-2018

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/201801
Europe - EMA - European Medicines Agency
10-9-2018

Phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010430/201711
Europe - EMA - European Medicines Agency
10-9-2018

Ciprofloxacin hydrochloride / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00000774/201711
Europe - EMA - European Medicines Agency
10-8-2018

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 (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 (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 (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 (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 (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018
Europe -DG Health and Food Safety
5-7-2018

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open
This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.
Europe - EMA - European Medicines Agency
3-7-2018

Efficib (Merck Sharp and Dohme B.V.)
Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90
Europe -DG Health and Food Safety
3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)
Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77
Europe -DG Health and Food Safety
3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)
Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93
Europe -DG Health and Food Safety
3-7-2018

Janumet (Merck Sharp and Dohme B.V.)
Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90
Europe -DG Health and Food Safety
29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)
EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18
Europe -DG Health and Food Safety