CLINDAMYCIN-LINK

Main information

  • Trade name:
  • CLINDAMYCIN-LINK clindamycin hydrochloride 150 mg hard capsules blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLINDAMYCIN-LINK clindamycin hydrochloride 150 mg hard capsules blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214526
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214526

CLINDAMYCIN-LINK clindamycin hydrochloride 150 mg hard capsules blister pack

ARTG entry for

Medicine Registered

Sponsor

Luminarie Pty Ltd

Postal Address

40 Roxburgh Crescent,STANHOPE GARDENS, NSW, 2768

Australia

ARTG Start Date

18/08/2014

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. CLINDAMYCIN-LINK clindamycin hydrochloride 150 mg hard capsules blister pack

Product Type

Single Medicine Product

Effective date

15/06/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

CLINDAMYCIN-LINK (clindamycin hydrochloride) capsules are indicated in the treatment of serious infections caused by susceptible anaerobic

bacteria.,CLINDAMYCIN-LINK 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

36 Months

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Moisture

Protect from Heat

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. CLINDAMYCIN-LINK clindamycin hydrochloride 150 mg hard capsules blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

No. 2 apple green capsule and imprinted with CLD 150

Active Ingredients

clindamycin hydrochloride

162.868 mg

Public Summary

Page 1 of

Produced at 26.11.2017 at 09:30:07 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 09:30:07 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

CLINDAMYCIN-LINK

®

capsules

Clindamycin hydrochloride

clin-da-mycin

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some

common questions about

CLINDAMYCIN-LINK®

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 risks and

benefits. Your doctor has

weighed the risks of you

taking CLINDAMYCIN-

LINK capsules against the

benefits this medicine is

expected to have for you.

If you have any concerns

about using this medicine,

ask your doctor or

pharmacist.

Keep this leaflet with your

medicine.

You may need to read it

again.

WHAT

CLINDAMYCIN-LINK

CAPSULES ARE

USED FOR

CLINDAMYCIN-LINK

capsule is an antibiotic. It is

used to treat infections in

different parts of the body

caused by bacteria.

CLINDAMYCIN-LINK

capsules works by killing or

stopping the growth of the

bacteria causing your

infection.

CLINDAMYCIN-LINK

capsules will not work against

viral infections such as colds

or flu.

CLINDAMYCIN-LINK

capsules are recommended

for patients who are allergic

to penicillin or patients for

whom penicillin is not

suitable.

Your doctor may have

prescribed CLINDAMYCIN-

LINK capsules for another

reason. Ask your doctor if

you have any questions about

why CLINDAMYCIN-LINK

capsules has been prescribed

for you.

This medicine is available

only with a doctor's

prescription.

CLINDAMYCIN-LINK

capsule is not addictive.

BEFORE TAKING

CLINDAMYCIN-LINK

CAPSULES

When you must not take

CLINDAMYCIN-LINK

capsules

Do not take

CLINDAMYCIN-LINK

capsules:

1.

if you have an allergy to:

clindamycin or

lincomycin

lactose or any of the other

ingredients listed at the

end of this leaflet

Symptoms of an allergic

reaction may include skin

rash, itching or difficulty

in breathing.

2.

if the packaging is torn

or shows signs of

tampering

3.

after the expiry date

(EXP) printed on the

label.

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

CLINDAMYCIN-LINK

capsules, talk to your doctor.

Before you start to take

CLINDAMYCIN-LINK

capsules

You must tell your doctor

about all of the following

before you start to take

CLINDAMYCIN-LINK

capsules:

1.

if you have any allergies

to any other medicines or

any other substances

such as foods,

preservatives or dyes.

2.

if you are pregnant or

intend to become

pregnant

Clindamycin crosses the

placenta

therefore

CLINDAMYCIN-LINK

capsules should only be

Link Medical Products Pty Ltd

Version 02

Page 1 of 4

used in pregnancy if

clearly needed. Your

doctor will discuss the

risks and benefits of taking

CLINDAMYCIN-LINK

capsules during pregnancy.

3.

if you are breastfeeding

or plan to breastfeed.

CLINDAMYCIN-LINK

capsules are not

recommended during

breastfeeding

.

4.

if you have or have ever

had:

severe diarrhoea

associated with the use of

antibiotics

severe liver disease

severe kidney disease

any gastrointestinal

(stomach or gut) problems

5.

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

CLINDAMYCIN-LINK

capsules.

Taking other medicines

Tell your doctor if you are

taking any other medicines,

including medicines you buy

without a prescription from

a pharmacy, supermarket

or health food shop.

There may be interference

between CLINDAMYCIN-

LINK capsules

and some

other medicines including:

the antibiotic,

erythromycin

medicines used for muscle

relaxation in anaesthesia

These medicines may be

affected by CLINDAMYCIN-

LINK capsules or may affect

how well CLINDAMYCIN-

LINK capsules work. You

may need different amounts

of your medicine or you may

need to take different

medicines. Your doctor or

pharmacist may have more

information on medicines to

be careful with or avoid while

taking CLINDAMYCIN-

LINK capsules.

HOW TO TAKE

CLINDAMYCIN-LINK

CAPSULES

Your doctor or pharmacist

will tell you how to take your

CLINDAMYCIN-LINK

capsules.

Follow all directions given

to you by your doctor and

pharmacist carefully.

Their directions 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.

The directions your doctor or

pharmacist gives you should

be strictly followed.

If you do not understand the

instructions in this leaflet, ask

your doctor or pharmacist for

help.

How much to take and

how long to take it

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

CLINDAMYCIN-LINK

capsules are not

recommended in children for

formulation reasons.

Continue taking

CLINDAMYCIN-LINK

capsules 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

CLINDAMYCIN-LINK

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.

How to take it and when

to take it

CLINDAMYCIN-LINK

capsules should be taken by

mouth, with a full glass of

water. CLINDAMYCIN-

LINK capsules can be taken

with or without food, it does

not matter.

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.

Link Medical Products Pty Ltd

Version 02

Page 2 of 4

Do not double a dose to

make up for the dose you

have missed.

If you take too much

(overdose)

Immediately telephone your

doctor or Poisons Information

Centre (telephone 13 11 26)

for advice, or go to Accident

and Emergency (Casualty) at

your nearest hospital if you

think that you or anyone else

may have taken too much

CLINDAMYCIN-LINK. Do

this even if there are no signs

of discomfort or poisoning.

You may need urgent medical

attention.

Keep telephone numbers for

these places/services handy.

Have the CLINDAMYCIN-

LINK box or this leaflet

available to give details if

needed.

WHILE YOU ARE

TAKING

CLINDAMYCIN-LINK

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

CLINDAMYCIN-LINK

capsules.

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 CLINDAMYCIN-

LINK capsules, 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

CLINDAMYCIN-LINK

allows fungi/yeast to grow,

and the above symptoms to

occur. CLINDAMYCIN-

LINK does not work against

fungi/yeast.

If you become pregnant while

taking CLINDAMYCIN-

LINK, tell your doctor

immediately.

If you are about to start taking

any new medicines, tell your

doctor and pharmacist that

you are taking

CLINDAMYCIN-LINK.

Tell all doctors, dentists and

pharmacists who are

treating you that you are

taking CLINDAMYCIN-

LINK.

If you feel that

CLINDAMYCIN-LINK is

not helping your condition,

tell your doctor.

Tell your doctor if, for any

reason, you have not used

CLINDAMYCIN-LINK

exactly as prescribed.

Things you must not do

Do not give

CLINDAMYCIN-LINK to

anyone else, even if they have

the same condition as you.

Do not use CLINDAMYCIN-

LINK to treat any other

medical complaints unless

your doctor tells you to.

SIDE EFFECTS

Check with your doctor or

pharmacist as soon as

possible if you have any

problems while taking

CLINDAMYCIN-LINK,

even if you do not think the

problems are connected

with the medicine or are not

listed in this leaflet.

Like other medicines,

CLINDAMYCIN-LINK can

cause some side effects. If

they occur, most are likely to

be minor and temporary.

However, some may be

serious and need medical

attention.

Ask your doctor or

pharmacist to answer any

questions you may have.

Tell your doctor 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

Link Medical Products Pty Ltd

Version 02

Page 3 of 4

skin rash; severe irritation

of the skin

jaundice (yellowing of the

skin)

joint pain and swelling

Tell your doctor

immediately if you notice

any of the following side

effects while you are taking

CLINDAMYCIN-LINK

capsules or several weeks

after stopping treatment:

severe stomach cramps;

watery and severe

diarrhoea which may also

be bloody;

fever in combination with

one or both of the above.

These are rare, but serious

side effects. You may need

urgent medical attention.

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.

Do not be alarmed by this list

of possible side effects. You

may not experience any of

them.

AFTER USING

CLINDAMYCIN-LINK

CAPSULES

Storage

Keep your

CLINDAMYCIN-LINK

capsules in their original

container where the

temperature stays below 30

degrees C and protected

from light, heat and

moisture.

If you take the capsules out of

their original container, they

may not keep as well.

Do not store your

CLINDAMYCIN-LINK

capsules, or any other

medicine, in a bathroom or

near a sink. Do not leave

them in the car or on

window sills.

Heat and dampness can

destroy some medicines.

Keep your

CLINDAMYCIN-LINK

capsules where children

cannot reach them.

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

using CLINDAMYCIN-

LINK capsules or the

capsules have passed their

expiry date, ask your

pharmacist what to do with

any capsules left over.

PRODUCT

DESCRIPTION

What it looks like

CLINDAMYCIN-LINK

capsules with a strength of

150 mg are available in packs

of 24 capsules, 50 capsules

and 100 capsules. The No. 2

Apple Green capsules are

marked with "CLD 150".

Ingredients

The active ingredient in

CLINDAMYCIN-LINK is

clindamycin hydrochloride.

CLINDAMYCIN-LINK also

contains Microcrystalline

Cellulose, Lactose

Anhydrous, Povidone,

Sodium Starch Glycolate,

Talc and Magnesium Stearate.

The capsule is a Hard Gelatin

Capsules size 2 P Lt Green

Op / Plt Green Op

(proprietary ingredient

number: 109543) imprinted

with the text CLD 150 using

the ink TekPrint SB-007P

White Ink (proprietary

ingredient number: 2216).

Supplier

CLINDAMYCIN-LINK

capsules are supplied in

Australia by:

Link Medical Products Pty

5 Apollo Street

Warriewood NSW 2102

Australian Register

Number(s)

150 mg Capsules

AUST R 214526

This leaflet was prepared in

September 2014

Link Medical Products Pty Ltd

Version 02

Page 4 of 4

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30-9-2018

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied.  Selected applications will be announced in November. For more information about the challenge, click the link:   https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk  pic.twitter.com/pFJZ39oGJC

FDA - U.S. Food and Drug Administration

29-9-2018

Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application:  https://go.usa.gov/xP4Nk pic.twitter.com/lLYiMa0cLe

Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application: https://go.usa.gov/xP4Nk pic.twitter.com/lLYiMa0cLe

Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application: https://go.usa.gov/xP4Nk  pic.twitter.com/lLYiMa0cLe

FDA - U.S. Food and Drug Administration

26-9-2018

#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA’s role in regulating contraceptive devices to protect your sexual health:  https://go.usa.gov/xPDQw 

#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA’s role in regulating contraceptive devices to protect your sexual health: https://go.usa.gov/xPDQw 

#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA’s role in regulating contraceptive devices to protect your sexual health: https://go.usa.gov/xPDQw 

FDA - U.S. Food and Drug Administration

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

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

25-9-2018

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices:  http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: https://go.usa.gov/xPjCj  pic.twitter.com/yVSNlc5Qb0

FDA - U.S. Food and Drug Administration

24-9-2018

aimed at determining how best to assess safety and effectiveness of digital health technologies without inhibiting patient access. Click on the link to register:  https://bit.ly/2pxdczF 

aimed at determining how best to assess safety and effectiveness of digital health technologies without inhibiting patient access. Click on the link to register: https://bit.ly/2pxdczF 

aimed at determining how best to assess safety and effectiveness of digital health technologies without inhibiting patient access. Click on the link to register: https://bit.ly/2pxdczF 

FDA - U.S. Food and Drug Administration

24-9-2018

For more information about the #FDA’s effort to address the epidemic of  #opioid addiction, click the link to find out more about the  #FDAInnovationChallenge:  https://go.usa.gov/xPja7  The last day to submit  applications is September 30th, 2018.https:/

For more information about the #FDA’s effort to address the epidemic of #opioid addiction, click the link to find out more about the #FDAInnovationChallenge: https://go.usa.gov/xPja7  The last day to submit applications is September 30th, 2018.https:/

For more information about the #FDA’s effort to address the epidemic of #opioid addiction, click the link to find out more about the #FDAInnovationChallenge: https://go.usa.gov/xPja7  The last day to submit applications is September 30th, 2018. https://twitter.com/NIDAnews/status/1032719474934382593 …

FDA - U.S. Food and Drug Administration

21-9-2018

Click the link for a handy list of #FDA’s recommendations for using and  caring for your medical devices during a #hurricane.   https://go.usa.gov/xPbgc  #MedicalDevice

Click the link for a handy list of #FDA’s recommendations for using and caring for your medical devices during a #hurricane. https://go.usa.gov/xPbgc  #MedicalDevice

Click the link for a handy list of #FDA’s recommendations for using and caring for your medical devices during a #hurricane. https://go.usa.gov/xPbgc  #MedicalDevice

FDA - U.S. Food and Drug Administration

21-9-2018

#DYK #hurricane season is active through November. Be prepared & stay informed of #MedicalDevice safety. Click the link to find a useful planning booklet from the #FDA that can help u prepare & handle power outages for medical devices that use electricity

#DYK #hurricane season is active through November. Be prepared & stay informed of #MedicalDevice safety. Click the link to find a useful planning booklet from the #FDA that can help u prepare & handle power outages for medical devices that use electricity

#DYK #hurricane season is active through November. Be prepared & stay informed of #MedicalDevice safety. Click the link to find a useful planning booklet from the #FDA that can help u prepare & handle power outages for medical devices that use electricity: https://go.usa.gov/xPbYt 

FDA - U.S. Food and Drug Administration

21-9-2018

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like  activity trackers, social media, and patient registries to better  understand their needs.  Click the link for more information about the upcoming meeting:  https:/

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like activity trackers, social media, and patient registries to better understand their needs. Click the link for more information about the upcoming meeting: https:/

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like activity trackers, social media, and patient registries to better understand their needs. Click the link for more information about the upcoming meeting: https://bit.ly/2MUNqhU 

FDA - U.S. Food and Drug Administration

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

17-9-2018

We had lots of great questions from potential applicants during our recent webinar. Check out the recording for Q&A about the #FDAInnovationChallenge. Click the link for the webinar recording:  https://go.usa.gov/xP4N5  #FDA #MedicalDevices

We had lots of great questions from potential applicants during our recent webinar. Check out the recording for Q&A about the #FDAInnovationChallenge. Click the link for the webinar recording: https://go.usa.gov/xP4N5  #FDA #MedicalDevices

We had lots of great questions from potential applicants during our recent webinar. Check out the recording for Q&A about the #FDAInnovationChallenge. Click the link for the webinar recording: https://go.usa.gov/xP4N5  #FDA #MedicalDevices

FDA - U.S. Food and Drug Administration

14-9-2018

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices:  http://go.usa.gov/xPg2A 

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices: http://go.usa.gov/xPg2A 

#FDA awards five grants to advance the development of pediatric medical devices. Click the link to read more about the grants and the FDA's work to advance the development of pediatric #MedicalDevices: http://go.usa.gov/xPg2A 

FDA - U.S. Food and Drug Administration

14-9-2018

#FDA's Dr. Binita Ashar provides a statement on continuing the agency’s commitment to studying breast implant safety. To read the statement, click the link:  https://go.usa.gov/xPg4C  #MedicalDevices

#FDA's Dr. Binita Ashar provides a statement on continuing the agency’s commitment to studying breast implant safety. To read the statement, click the link: https://go.usa.gov/xPg4C  #MedicalDevices

#FDA's Dr. Binita Ashar provides a statement on continuing the agency’s commitment to studying breast implant safety. To read the statement, click the link: https://go.usa.gov/xPg4C  #MedicalDevices

FDA - U.S. Food and Drug Administration

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

6-9-2018

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program:  https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa  #MedicalDevice pic.twitter.com/dOcFpbed9K

FDA - U.S. Food and Drug Administration

5-9-2018

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application:  https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.usa.gov/xPcpn  #MedicalDevice

FDA - U.S. Food and Drug Administration

5-9-2018

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments:  h

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments: h

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments: https://go.usa.gov/xPcpT  pic.twitter.com/hAuLWaIYiK

FDA - U.S. Food and Drug Administration

5-9-2018

Click the link for more information about the workshop and how to register:  https://go.usa.gov/xPcVM  #MedicalDevice

Click the link for more information about the workshop and how to register: https://go.usa.gov/xPcVM  #MedicalDevice

Click the link for more information about the workshop and how to register: https://go.usa.gov/xPcVM  #MedicalDevice

FDA - U.S. Food and Drug Administration

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

6-8-2018

Today is the last day to register to attend the Pediatric Medical Device Development public meeting in person. Click the link to learn more and register. #Pediatrics #medicaldevice  https://go.usa.gov/xUvBD pic.twitter.com/mWuQWK9MLk

Today is the last day to register to attend the Pediatric Medical Device Development public meeting in person. Click the link to learn more and register. #Pediatrics #medicaldevice https://go.usa.gov/xUvBD pic.twitter.com/mWuQWK9MLk

Today is the last day to register to attend the Pediatric Medical Device Development public meeting in person. Click the link to learn more and register. #Pediatrics #medicaldevice https://go.usa.gov/xUvBD  pic.twitter.com/mWuQWK9MLk

FDA - U.S. Food and Drug Administration

31-7-2018

During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more.  https://go.usa.gov/xUvBD  #Pedi

During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more. https://go.usa.gov/xUvBD  #Pedi

During the Pediatric Medical Device Development, public meeting, the #FDA will highlight pathways to encourage the development of medical devices for children. There is still time to register! Click the link to learn more. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevice pic.twitter.com/UzKDyAyER5

FDA - U.S. Food and Drug Administration

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

22-7-2018

We'll establish a robust medical device patient safety net by continuing our work on NEST, or the National Evaluation System for health Technology. NEST links data from registries, EHRs and billing claimspic.twitter.com/m2UaZ6gEaV

We'll establish a robust medical device patient safety net by continuing our work on NEST, or the National Evaluation System for health Technology. NEST links data from registries, EHRs and billing claimspic.twitter.com/m2UaZ6gEaV

We'll establish a robust medical device patient safety net by continuing our work on NEST, or the National Evaluation System for health Technology. NEST links data from registries, EHRs and billing claims pic.twitter.com/m2UaZ6gEaV

FDA - U.S. Food and Drug Administration

17-7-2018

The #FDA invites you to join us and discuss how we can increase medical device options for children at the Pediatric Medical Device Development public meeting. Click the link to register.  #Pediatrics  https://go.usa.gov/xUXHq  #MedicalDevicepic.twitter.c

The #FDA invites you to join us and discuss how we can increase medical device options for children at the Pediatric Medical Device Development public meeting. Click the link to register. #Pediatrics https://go.usa.gov/xUXHq  #MedicalDevicepic.twitter.c

The #FDA invites you to join us and discuss how we can increase medical device options for children at the Pediatric Medical Device Development public meeting. Click the link to register. #Pediatrics https://go.usa.gov/xUXHq  #MedicalDevice pic.twitter.com/hL7vawmOgR

FDA - U.S. Food and Drug Administration

16-7-2018

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information  http://go.usa.gov/xQvE9 pic.twitter.

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information http://go.usa.gov/xQvE9 pic.twitter.

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information http://go.usa.gov/xQvE9  pic.twitter.com/kT7EqyTPxr

FDA - U.S. Food and Drug Administration