News from the CHMP and CMDh – October 2013
30.10.2013
CMDh adopted the PRAC’s decision about the restriction of use of hydroxyethyl-starch containing solution for infusion (HES)
The Co-ordination Group for mutual recognition procedure and decentralised procedure for human medicine (CMDh) has adopted by the majority of votes recommendations of the Pharmacovigilance Risk Committee (PRAC) of the European Medicines Agency (EMA) related to the restriction of use of hydroxyethyl-starch containing solutions for infusion (HES). HALMED reported earlier about these recommendations on its web pages and the information is accessible here. The CMDh decision is forwarded to the European Commission for the adoption of a legally binding decision at the EU level.
CMDh adopted the PRAC recommendations about the restrictions of use of short-acting beta-agonists in obstetric indications
CMDh has unanimously adopted the PRAC recommendation about the restriction of use of beta agonists in obstetric indications, which makes this recommendation legally binding at the EU level. The PRAC has recommended that oral forms and suppositories of short-acting beta gonists be no longer used in obstetric indications (for the care of pregnant women), such for suppressing premature labour or excessive labour contractions. However, injectable forms of these medicines can still be given for short-term obstetric use under specific conditions.
CHMP confirmed the previous recommendations about the restriction of use of dihydroergotoxins
The Committee for Human Medicinal Products of the European Medicines Agency (EMA) has confirmed its earlier recommendation about the restriction of use of dihydroergotoxins. The CHMP adopted earlier the recommendations with regard to restriction of dihydroergocrystine, dihydroergotamine, dihydroergotoxin, nicergoline and a combination of dihydroergocryptine and caffeine, and a re-assessment of dihydroergotoxin has been carried out at the request of the marketing authorisation holder and will be forwarded to the European Commission for adoption of legally binding decisions at the EU level. HALMED reported earlier about these recommendations, on its web pages and the information is accessible here.
CHMP confirmed earlier recommendation about the restriction of the use of metoclopramide.
The CHMP has confirmed the earlier recommendation about the restriction of use of metoclopramide. The CHMP received earlier recommendations about the restriction of use of this medicine in order to minimise the risk from potentially serious neurologic side effects and the re-assessment of this safety issue has been carried out at the request of marketing authorisation holder and will be forwarded to the European Commission for adoption of legally binding decisions at the EU level. HALMED reported earlier about these recommendations, via its web pages and the information is accessible here.
CHMP recommended restriction of use of intravenous nicardipine
The CHMP has concluded that intravenous nicardipine forms should be used only in the treatment of an acute life-threatening hypertension and for the control of hypertension after surgery, whereas the use of intravenous nicardipine in other indications is no longer recommended. The CHMP has also recommended that these medicines may be given only as a continuation infusion (drip) by spacialists in hospital setting or intensive care unit. The CHMP recommendation is forwarded to the European Commission for adoption of a legally binding decision at the EU level. Detailed information about this recommendation is available here.
