May 2, 2013 - CMDh endorses PRAC advice to take Tetrazepam-containing medicinal products off the market

The Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMD(h)), in which the Medicines Evaluation Board (MEB) is represented, has decided to endorse the advice of the Pharmacovigilance Risk Assessment (PRAC), and has thus advised the European Commission to take Tetrazepam-containing medicinal products off the market at the European level.

May 1, 2013 - New procedure for medicines under additional monitoring

The European Union (EU) has introduced a new process to label medicines that are being monitored particularly closely by regulatory authorities. These medicines are described as being under 'additional monitoring'.

April 16, 2013 - Monthly PRAC Report - April 2013

The Pharmacovigilance Risk Assessment Committee (PRAC) took place from 8-11 April. The Dutch Medicines Evaluation Board (MEB) is also represented in this committee.

April 15, 2013 - In very rare circumstances MabThera can lead to severe skin reactions

In consultation with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the Dutch Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ), Roche would like to inform you of the risk of severe skin reactions in very rare circumstances when using MabThera.

April 8, 2013 - Children are an at-risk group when using serum calcium lowering medicine Mimpara

In consultation with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the Dutch Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ), Amgen would like to inform you of the occurrence of a fatal case with severe hypocalcemia in a pediatric investigational study involving a patient receiving cinacalcet (Mimpara). Cinacalcet is approved only in adults. Prescribers are reminded that since cinacalcet lowers serum calcium, patients should be monitored carefully for the occurrence of hypocalcaemia.

April 8, 2013 - Risk of acute graft rejection associated with rapid corticosteroid taper when using Nulojix

In consultation with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the Dutch Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ), Bristol-Myers Squibb would like to inform you of the risk of acute graft rejection associated with rapid corticosteroid taper when using Nulojix.

March 26, 2013 - European (Marketing) Authorisation of Medicines in March 2013

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2013.

Read the meeting highlights (March 2013).

March 20, 2013 - Improvements in the search functions of the Medicines data bank on the MEB website

Based on the wishes and comments from the clinical practice of (hospital) pharmacists and doctors, the Medicines Evaluation Board (MEB) has implemented improvements in the search functions on the website. This is the first in a series of improvements and we are working on subsequent improvements to expand and improve on information disclosure.

March 12, 2013 - Monthly PRAC report – March 2013

The meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) took place on 4 – 7 March. The Dutch Medicines Evaluation Board (MEB) is also represented on this committee.

March 11, 2013 - Start of review of medicinal products containing domperidone

The meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) took place on 4 – 7 March. The Dutch Medicines Evaluation Board (MEB) is also represented on this committee.

March 8, 2013 - Recall Vistide leads to shortage in supply

In consultation with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the Dutch Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ), Gilead would like to inform you of the recall of Vistide, leading to a shortage in commercial supply in the EU.

March 7, 2013 - Decision on objection Cortiment

The Medicines Evaluation Board (MEB) has decided on the appeal by the company Cosmo Technologies Ltd. during the meeting on 31 January 2013.
Cosmo submitted an appeal on 2 October 2012 against the MEB decision of 13 September 2012 to refuse the following marketing authorisation:
Cortiment 9 mg, acid resistant tablets (RVG 110023, active ingredient budesonide).

March 4, 2013 - MEB recommendation: Diane-35 remains available, but is not recommended for new patients

The Medicines Evaluation Board (MEB) advises doctors not to prescribe Diane-35 to new patients at this time. The product will remain available for patients currently being treated (e.g. patient with acne). The MEB is concerned about the recent reports related to Diane-35 which recently have become available and is closely monitoring the latest developments on this issue.

March 1, 2013 - Information following authorisation of high dose insulin (Tresiba)

Tresiba (insulin degludec) was recently authorised in all EU member states – including the Netherlands – for the treatment of diabetes mellitus. A strength that is higher than usual (200 units per mL instead of 100 units per mL) has also been authorised. The packaging and labels of the injection pens have been modified so that the difference is clearly visible.

February 25, 2013 - European (Marketing) Authorisation of Medicines in February 2013

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 February 2013.

Read the meeting highlights (February 2013).

February 22, 2013 - Risk of atypical femoral fracture with Prolia

In consultation with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the Dutch Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ), Amgen would like to inform you of the risk of atypical femoral fracture associated with the use of Prolia.

February 18, 2013 - Update on falsified medicinal products legislation

The Directive on falsified medicinal products came into effect on 2 January 2013. In The Netherlands, this Directive still needs to be transposed into the Medicines Act, and applies to the import of raw materials used in medicinal products for human use into EU and EFTA countries.

February 14, 2013 - Monthly PRAC Report - February 2013

The Pharmacovigilance Risk Assessment Committee (PRAC) meeting took place from 4 - 7 February. The Dutch Medicines Evaluation Board (MEB) is also represented in this committee.

February 11, 2013 - Questions and reports about Diane-35

Diane-35 and its generic variations (cyproterone acetate and ethinyl estradiol) are currently receiving much attention. The Medicines Evaluation Board (MEB) receives reports about adverse events that have occurred during the use of these medicines.

February 8, 2013 - Safety review of Diane-35 and its generics

The meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) took place on 4 to 7 February. The Medicines Evaluation Board (MEB) is also represented in this committee.

February 4, 2013 - Update about Diane-35

France has announced that it is taking the Diane-35 pill from the market soon. The Medicines Evaluation Board (MEB) approved the medicine for the Netherlands in 1987 for the treatment of acne, oily skin or mild hirsutism (excessive hair growth) in women of childbearing age, if a doctor deems treatment with hormones necessary.

January 31, 2013 - New explanation about the contents of an SmPC

The European Medicines Agency (EMA) has published new web pages providing information about drafting an SmPC, the production information for doctors and pharmacists. The pages contain presentations about drafting the SmPC, divided per section. An explanation is also provided in a video.

January 25, 2013 - Increased risk of cardiovascular adverse events when using Xagrid

In consultation with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the Dutch Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ), Shire would like to inform you of the increased risk of cardiovascular adverse events when using Xagrid.

January 22, 2013 - Altered recommendations Gilenya

In consultation with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the Dutch Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ), Novartis would like to inform you of the refined guidance on when first dose monitoring procedures should be repeated for Gilenya.

January 21, 2013 - European (Marketing) Authorisation of Medicines in January 2013

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 January 2013.

January 18, 2013 - CHMP follows PRAC recommendation: efficacy/risk balance for Tredaptive (nicotinic acid and laropiprant) no longer positive

The Committee for Medicinal Products for Human Use (CHMP) has concluded that the risks for the use of Tredaptive (nicotinic acid and laropiprant) are no longer outweighed by the benefits of the medicinal product.

January 15, 2013 - Dosing regimens for Angiox need to be followed carefully

In consultation with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the Dutch Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ), The Medicines Company would like to inform you of the approved dosing regimens for Angiox (bivalirudin) for PCI, following reports of inappropriate use.

January 11, 2013 - Monthly PRAC report - January 2013

The meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) took place on 7 – 10 January. The Dutch Medicines Evaluation Board (MEB) is also represented on this committee.

January 10, 2013 - Re-evaluation of efficacy and risks of Tredaptive

The efficacy and risks of Tredaptive - a combination of nicotinic acid and laropiprant – are being re-evaluated. This is necessary because the medicinal product in combination with a statin did not produce the expected reduction in cardiovascular complications or mortality, but did produce serious adverse effects.

January 4, 2013 - New contraindication for Pradaxa

In consultation with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the Dutch Medicines Evaluation Board (MEB) and the Health Care Inspectorate (IGZ), Boehringer Ingelheim would like to inform you that the use of the medicinal product dabigatran (Pradaxa) is now contraindicated in patients with prosthetic heart valves requiring anticoagulant treatment.

January 4, 2013 - Maximum limit on the package size for paracetamol

There are sufficient indications that the use of paracetamol is increasing, accompanied by a growing number of reports of overdosing. Therefore, the Medicines Evaluation Board (MEB) is restricting the size of the packaging of paracetamol 500 mg that is freely available from the drugstore to 50 pills per package.