news

May 3, 2012 - Temporary solution for shortage of Semap (penfluridol)

In March 2012, the French authorities informed the Medicines Evaluation Board (MEB) that problems might occur with the availability of Semap (penfluridol). Considering the clinical importance of this product, the MEB contacted the French supplier Alkopharm based on this information.

April 27, 2012 - Risk of accidental overdose with Perfalgan

In agreement 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 B.V. would like to inform you on the risk of accidental overdose with intravenous paracetamol (Perfalgan).

April 19, 2012 - Marketing authorisation VSM for Rinileen tablets rightly withdrawn

On Wednesday, 18 April 2012, the Council of State gave judgment in the case between VSM and the Medicines Evaluation Board (MEB). The Council of State ruled that the MEB acted rightly in withdrawing the marketing authorisation for Rinileen tablets. VSM has not scientifically proven the claimed effect, as stated on the packaging and the package leaflet.

April 13, 2012 - Recall Alimta due to a quality defect

In agreement 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), Eli Lilly would like to inform you that Eli Lilly is conducting a voluntary recall of pemetrexed disodium (Alimta) 500 mg vials (3 lots), due to potential microbial contamination.

April 5, 2012 - New contraindications for Protelos

In agreement 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), Servier Nederland Farma B.V. would like to inform you on the importance of new contraindications for strontium ranelate (Protelos).

March 22, 2012 - First Authorisation of Traditional Herbal Medicine from outside the European Union

On 14 March 2012, the Dutch Medicines Evaluation Board (MEB) for the first time in the European Union granted a marketing authorisation to a herbal medicinal product based on traditional use, manufactured in Chengdu, China.

March 20, 2012 - European (Marketing) Authorisation of Medicines in March 2012

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 March 2012.

Read the meeting highlights (March 2012)

March 2, 2012 - Register now: 2nd Informative Meeting on the Implications of the New Pharmacovigilance Legislation

On Tuesday 24 April 2012, the Dutch Medicines Evaluation Board (MEB) will organise a second informative meeting for marketing authorisation holders on the implications of the new pharmacovigilance legislation which enters into force in July 2012.

February 21, 2012 - European (Marketing) Authorisation of Medicines in February 2012

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 February 2012.

Read the meeting highlights (February 2012)

February 17, 2012 - Benefit-risk balance Alli and Xenical remains positive

The efficacy of orlistat (Alli and Xenical) still outweighs the possible health risks associated with the products containing this active ingredient.

January 25, 2012 - Subscribe to important medicinal product risk information newsletter

The Medicines Evaluation Board (MEB) wishes to draw your attention to the existence of our newsletter for important risk information about medicinal products. This newsletter (in Dutch) gives you new, important information about risks of a medicinal product.

January 24, 2012 - European (Marketing) Authorisation of Medicines in January 2012

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 January 2012.

Read the meeting highlights January 2012.

January 20, 2012 - The correct administration of Velcade is via the intravenous route

The company Janssen-Cilag B.V. has sent a letter to doctors and pharmacists. The purpose of this communication is to remind you that the correct procedure for administering Velcade (bortezomib) 1 mg and 3.5 mg powder for solution for injection is via the intravenous route and to recommend some measures to reduce the risk of incorrect administration.