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31-5-2018

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Abbott is communicating to physicians about a field corrective action related to the HeartMate 3™ Left Ventricular Assist Device (LVAD). Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting.

FDA - U.S. Food and Drug Administration

8-5-2018

New Tariff for fees collected by the Icelandic
Medicines Agency

New Tariff for fees collected by the Icelandic Medicines Agency

Tariff No 404/2018 for marketing authorisations, annual fees and other licence fees for medicinal products and other related products, collected by the Icelandic Medicines Agency, was published in the Official Journal on 25th of april 2018 and came into force on the 7th of May 2018.TARIFF No 545/2017 for inspections and registration regarding medical devices remains the same. 

IMA - Icelandic Medicines Agency

4-5-2018

Badger Botanicals Recalls Red Suma, Green Suma, Green Hulu 2, And Red Hulu 2 Kratom Supplements Because Of Possible Salmonella Health Risk

Badger Botanicals Recalls Red Suma, Green Suma, Green Hulu 2, And Red Hulu 2 Kratom Supplements Because Of Possible Salmonella Health Risk

Badger Botanicals, LLC of Springville, Utah is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 kratom dietary supplements sold directly to consumers via the company website from January 1st, 2018 to April l 12th, 2018 in pouches of 250g, because it has the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

2-5-2018

April 17, 2018: Tampa Resident Sentenced to More Than 20 Years in Federal Prison for Tricare Health Care Fraud Scheme

April 17, 2018: Tampa Resident Sentenced to More Than 20 Years in Federal Prison for Tricare Health Care Fraud Scheme

April 17, 2018: Tampa Resident Sentenced to More Than 20 Years in Federal Prison for Tricare Health Care Fraud Scheme

FDA - U.S. Food and Drug Administration

30-4-2018

April 27, 2018: Seller of Counterfeit and Unapproved Pharmaceuticals Sentenced to Prison

April 27, 2018: Seller of Counterfeit and Unapproved Pharmaceuticals Sentenced to Prison

April 27, 2018: Seller of Counterfeit and Unapproved Pharmaceuticals Sentenced to Prison

FDA - U.S. Food and Drug Administration

25-4-2018

Enforcement Report for the Week of April 25, 2018

Enforcement Report for the Week of April 25, 2018

FDA - U.S. Food and Drug Administration

19-4-2018

April 13, 2018: Canadian Drug Firm Admits Selling Counterfeit and Misbranded Prescription Drugs Throughout the United States

April 13, 2018: Canadian Drug Firm Admits Selling Counterfeit and Misbranded Prescription Drugs Throughout the United States

April 13, 2018: Canadian Drug Firm Admits Selling Counterfeit and Misbranded Prescription Drugs Throughout the United States

FDA - U.S. Food and Drug Administration

19-4-2018

April 12, 2018: Chinese Citizen Pleads Guilty to Mail Fraud Related to Dietary Supplement Scheme

April 12, 2018: Chinese Citizen Pleads Guilty to Mail Fraud Related to Dietary Supplement Scheme

April 12, 2018: Chinese Citizen Pleads Guilty to Mail Fraud Related to Dietary Supplement Scheme

FDA - U.S. Food and Drug Administration

19-4-2018

April 6, 2018: New Hampshire Residents Sentenced for Participating in Scheme to Distribute Misbranded Drugs

April 6, 2018: New Hampshire Residents Sentenced for Participating in Scheme to Distribute Misbranded Drugs

April 6, 2018: New Hampshire Residents Sentenced for Participating in Scheme to Distribute Misbranded Drugs

FDA - U.S. Food and Drug Administration

19-4-2018

April 4, 2018: Fences Indicted in Multi-Million Dollar, Multi-State Criminal Theft Operations

April 4, 2018: Fences Indicted in Multi-Million Dollar, Multi-State Criminal Theft Operations

April 4, 2018: Fences Indicted in Multi-Million Dollar, Multi-State Criminal Theft Operations

FDA - U.S. Food and Drug Administration

18-4-2018

Enforcement Report for the Week of April 18, 2018

Enforcement Report for the Week of April 18, 2018

FDA - U.S. Food and Drug Administration

12-4-2018

Z-classification revoked for S-classified medicinal products, which are foreseen to maintain their S-classified status

Z-classification revoked for S-classified medicinal products, which are foreseen to maintain their S-classified status

The Agency intends to revoke Z-classification of those S-classified medicinal products, which are foreseen to maintain their S-classified status. In case a marketing authorisation holder has any comments on the Agency´s planned action, such comments must be submitted before 16 April 2018.

IMA - Icelandic Medicines Agency

11-4-2018

Enforcement Report for the Week of April 11, 2018

Enforcement Report for the Week of April 11, 2018

FDA - U.S. Food and Drug Administration

4-4-2018

Enforcement Report for the Week of April 04, 2018

Enforcement Report for the Week of April 04, 2018

FDA - U.S. Food and Drug Administration

22-5-2017

Danish Pharmacovigilance Update, April 2017

Danish Pharmacovigilance Update, April 2017

The April issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

26-4-2017

Enforcement Report for the Week of April 26, 2017

Enforcement Report for the Week of April 26, 2017

FDA - U.S. Food and Drug Administration

19-4-2017

Enforcement Report for the Week of April 19, 2017

Enforcement Report for the Week of April 19, 2017

FDA - U.S. Food and Drug Administration

12-4-2017

Enforcement Report for the Week of April 12, 2017

Enforcement Report for the Week of April 12, 2017

FDA - U.S. Food and Drug Administration

5-4-2017

Enforcement Report for the Week of April 05, 2017

Enforcement Report for the Week of April 05, 2017

FDA - U.S. Food and Drug Administration

10-5-2016

Danish Pharmacovigilance Update, April 2016

Danish Pharmacovigilance Update, April 2016

The April issue of Danish Pharmacovigilance Update with news from the EU, the DKMA and short news.

Danish Medicines Agency

27-4-2016

Enforcement Report for the Week of April 27, 2016

Enforcement Report for the Week of April 27, 2016

FDA - U.S. Food and Drug Administration

20-4-2016

Enforcement Report for the Week of April 20, 2016

Enforcement Report for the Week of April 20, 2016

FDA - U.S. Food and Drug Administration

13-4-2016

Enforcement Report for the Week of April 13, 2016

Enforcement Report for the Week of April 13, 2016

FDA - U.S. Food and Drug Administration

6-4-2016

Enforcement Report for the Week of April 06, 2016

Enforcement Report for the Week of April 06, 2016

FDA - U.S. Food and Drug Administration

8-5-2015

Danish Pharmacovigilance Update, April 2015

Danish Pharmacovigilance Update, April 2015

The April issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news:

Danish Medicines Agency

29-4-2015

Enforcement Report for the Week of April 29, 2015

Enforcement Report for the Week of April 29, 2015

FDA - U.S. Food and Drug Administration

22-4-2015

Enforcement Report for the Week of April 22, 2015

Enforcement Report for the Week of April 22, 2015

FDA - U.S. Food and Drug Administration

15-4-2015

Enforcement Report for the Week of April 15, 2015

Enforcement Report for the Week of April 15, 2015

FDA - U.S. Food and Drug Administration

8-4-2015

Enforcement Report for the Week of April 08, 2015

Enforcement Report for the Week of April 08, 2015

FDA - U.S. Food and Drug Administration

1-4-2015

Enforcement Report for the Week of April 01, 2015

Enforcement Report for the Week of April 01, 2015

FDA - U.S. Food and Drug Administration

7-5-2014

Danish Pharmacovigilance Update  30 April 2014

Danish Pharmacovigilance Update 30 April 2014

In the April issue of Danish Pharmacovigilance Update:

Danish Medicines Agency

30-4-2014

Enforcement Report for the Week of April 30, 2014

Enforcement Report for the Week of April 30, 2014

FDA - U.S. Food and Drug Administration

23-4-2014

Enforcement Report for the Week of April 23, 2014

Enforcement Report for the Week of April 23, 2014

FDA - U.S. Food and Drug Administration

16-4-2014

Enforcement Report for the Week of April 16, 2014

Enforcement Report for the Week of April 16, 2014

FDA - U.S. Food and Drug Administration

9-4-2014

Enforcement Report for the Week of April 09, 2014

Enforcement Report for the Week of April 09, 2014

FDA - U.S. Food and Drug Administration

2-4-2014

Enforcement Report for the Week of April 02, 2014

Enforcement Report for the Week of April 02, 2014

FDA - U.S. Food and Drug Administration

29-5-2013

Danish Pharmacovigilance Update, 25 April 2013

Danish Pharmacovigilance Update, 25 April 2013

In this issue of Danish Pharmacovigilance Update: Cerebral haemorrhage in association with the use of methylphenidate (Ritalin® etc.).

Danish Medicines Agency

24-4-2013

Enforcement Report for the Week of April 24, 2013

Enforcement Report for the Week of April 24, 2013

FDA - U.S. Food and Drug Administration

17-4-2013

Enforcement Report for the Week of April 17, 2013

Enforcement Report for the Week of April 17, 2013

FDA - U.S. Food and Drug Administration

10-4-2013

Enforcement Report for the Week of April 10, 2013

Enforcement Report for the Week of April 10, 2013

FDA - U.S. Food and Drug Administration

3-4-2013

Enforcement Report for the Week of April 03, 2013

Enforcement Report for the Week of April 03, 2013

FDA - U.S. Food and Drug Administration

4-7-2012

Danish Pharmacovigilance Update, 19 April 2012

Danish Pharmacovigilance Update, 19 April 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Split and crushed tablets containing finasteride may pose a risk for pregnant and fertile women.

Danish Medicines Agency

26-4-2012

Enforcement Report for the Week of April 25, 2012

Enforcement Report for the Week of April 25, 2012

FDA - U.S. Food and Drug Administration

18-4-2012

Enforcement Report for the Week of April 18, 2012

Enforcement Report for the Week of April 18, 2012

FDA - U.S. Food and Drug Administration

13-4-2012

Enforcement Report for the Week of April 11, 2012

Enforcement Report for the Week of April 11, 2012

FDA - U.S. Food and Drug Administration

5-4-2012

Enforcement Report for the Week of April 4, 2012

Enforcement Report for the Week of April 4, 2012

FDA - U.S. Food and Drug Administration

13-5-2011

Danish Pharmacovigilance Update, April 2011

Danish Pharmacovigilance Update, April 2011

In this issue of Danish Pharmacovigilance Update, read about a new contraindication for Telzir® (fosamprenavir) for HIV treatment, reports of blood clots from the use of Vivaglobin®, and new, improved e-forms for reporting suspected adverse reactions and much more.

Danish Medicines Agency

21-4-2010

Decision on future reimbursement status of losartan-containing medicines (C09CA01 and C09DA01) - angiotensin II antagonists

Decision on future reimbursement status of losartan-containing medicines (C09CA01 and C09DA01) - angiotensin II antagonists

On 16 April 2010, the Danish Medicines Agency decided on the future reimbursement status of some of the losartan-containing medicines in ATC groups C09C and C09D, making these products eligible for general reimbursement as of 19 April 2010.

Danish Medicines Agency

29-3-2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

As of 23 April 2007, the reimbursement status of lipid lowering medicinal products will be changed. The decision includes all lipid lowering medicinal products with marketing authorisations in Denmark on 15 March 2007.

Danish Medicines Agency

15-6-2018

 Minutes of the CHMP meeting 23-26 April 2018

Minutes of the CHMP meeting 23-26 April 2018

Committee for medicinal products for human use (CHMP) minutes of the meeting on 23-26 April 2018

Europe - EMA - European Medicines Agency

11-6-2018

 Minutes of the PRAC meeting 9-12 April 2018

Minutes of the PRAC meeting 9-12 April 2018

Europe - EMA - European Medicines Agency

8-6-2018

 CHMP ORGAM minutes for the meeting on 16 April 2018

CHMP ORGAM minutes for the meeting on 16 April 2018

Europe - EMA - European Medicines Agency

6-6-2018

ACM meeting statement, Meeting 8, 5-6 April 2018

ACM meeting statement, Meeting 8, 5-6 April 2018

ACM meeting statement, meeting 8, April 2018

Therapeutic Goods Administration - Australia

30-5-2018

 Minutes of the CVMP meeting of 17–19 April 2018

Minutes of the CVMP meeting of 17–19 April 2018

Europe - EMA - European Medicines Agency

30-5-2018

 Minutes of the CVMP meeting of 17-19 April 2018

Minutes of the CVMP meeting of 17-19 April 2018

Europe - EMA - European Medicines Agency

3-5-2018

Agenda:  CHMP ORGAM agenda for the meeting on 16 April 2018

Agenda: CHMP ORGAM agenda for the meeting on 16 April 2018

Europe - EMA - European Medicines Agency

2-5-2018

TGA presentation: Medicines Australia Regulatory Affairs Working Group, 18 April 2018

TGA presentation: Medicines Australia Regulatory Affairs Working Group, 18 April 2018

Update on TGA activities from the Scientific Evaluation Branch

Therapeutic Goods Administration - Australia

9-4-2018

Human medicines highlights - April 2018

Human medicines highlights - April 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency