Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2013
PRAC recommendation on Diane 35 and generics
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2 mg / ethinylestradiol 35 micrograms) and its generics outweigh the risks in a specific patient group, provided that several measures are taken to minimise the risk of thromboembolism, including new contraindications and warnings.
The Committee adopted the recommendation following a thorough review in which it sought expert advice and considered feedback from healthcare professionals and users of these medicines.
The PRAC's recommendation will now be considered by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) which will take a final position. The CMDh is a regulatory body that represents national medicines regulatory authorities of the European Union (EU) Member States.
Links to the summary of the PRAC recommendation and to a press release are available in the table below.
PRAC recommends withdrawal of oral almitrine-containing medicines
The PRAC concluded that the benefits of almitrine-containing medicines no longer outweigh their risks, and recommended that all marketing authorisations for these medicines should be withdrawn across the EU.
Two new referral procedures started in May 2013
The PRAC started a review of Protelos / Osseor, a medicine containing strontium ranelate used for treating osteoporosis. The review has been started following a recent routine evaluation of safety data showing an increased risk of serious heart problems, including heart attack, with the medicine.
A review of the combined use of renin-angiotensin-system (RAS)-acting agents was also started by the PRAC.
The review of third- and fourth-generation combined hormonal contraceptives continues. An update from the PRAC is expected in July 2013.
For an overview of all information available following the meeting of the PRAC, please see the table below.
|Agenda - PRAC draft agenda of meeting 13-16 May 2013|
Start of referral procedures
|Protelos / Osseor|
Protelos / Osseor: Article-20 procedure
RAS-acting agents: Article-31 referral
Recommendations by PRAC
|Cyproterone / ethinylestradiol-containing medicines|
Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure
Almitrine-containing medicines: Article-31 referral
- Actelsar HCT: EPAR
- Aprovel: EPAR
- CoAprovel: EPAR
- Copalia: EPAR
- Copalia HCT: EPAR
- Dafiro: EPAR
- Dafiro HCT: EPAR
- Edarbi: EPAR
- Exforge: EPAR
- Exforge HCT: EPAR
- Ifirmacombi: EPAR
- Ifirmasta (previously Irbesartan Krka): EPAR
- Imprida: EPAR
- Ipreziv: EPAR
- Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop): EPAR
- Irbesartan Teva: EPAR
- Irbesartan Zentiva (previously Irbesartan Winthrop): EPAR
- Irbesartan/Hydrochlorothiazide Teva: EPAR
- Karvea: EPAR
- Karvezide: EPAR
- Kinzalkomb: EPAR
- Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG): EPAR
- Micardis: EPAR
- MicardisPlus: EPAR
- Onduarp: EPAR
- Osseor: EPAR
- Pritor: EPAR
- PritorPlus: EPAR
- Protelos: EPAR
- Rasilamlo: EPAR
- Rasilez: EPAR
- Rasilez HCT: EPAR
- Rasitrio: EPAR
- Sabervel: EPAR
- Telmisartan Actavis: EPAR
- Telmisartan Teva: EPAR
- Telmisartan Teva Pharma: EPAR
- Tolura: EPAR
- Twynsta: EPAR