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29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

26-6-2018

ANSES Newsletter in English - N°45 - April 2018

ANSES Newsletter in English - N°45 - April 2018

France - Agence Nationale du Médicament Vétérinaire

19-6-2018

Mine Safety Appliances Company LLC recalls MSA Nuevo Wrap Safety Glasses

Mine Safety Appliances Company LLC recalls MSA Nuevo Wrap Safety Glasses

Testing by the CSA Group has shown that glasses distributed between October 2017 and April 2018 do not comply with the side impact requirements of the safety standard for eye and face protectors. The affected safety glasses may not provide adequate protection against side impact, posing a risk of eye injury.

Health Canada

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

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

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

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

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

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

23-8-2018

 Minutes of the CAT meeting 18-20 April 2018

Minutes of the CAT meeting 18-20 April 2018

Europe - EMA - European Medicines Agency

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia

22-7-2018

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device and earlier agency actions

FDA - U.S. Food and Drug Administration

10-7-2018

 Minutes - PDCO minutes of the 24-27 April 2018 meeting

Minutes - PDCO minutes of the 24-27 April 2018 meeting

Europe - EMA - European Medicines Agency

28-6-2018

 Minutes of the COMP meeting of 17-19 April 2018

Minutes of the COMP meeting of 17-19 April 2018

Europe - EMA - European 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