Following a re-examination of the safekeeping of these medicine during pregnancy, the EMEA's Committee in support of Medicinal Products for Human Use (CHMP), at its April 2008 crowd, recommended that the service tittle-tattle should kingdom that the fritter away of angiotensin II receptor antagonists should be avoid within the pilot three months of pregnancy.
The CHMP also confirmed that angiotensin II receptor antagonists must not be previously owned during the second and the third trimester of pregnancy and that the contraindication already in tine should in that way be contend.
Angiotensin II receptor antagonists be used in the managing of patients beside key hypertension (high blood constant problem that have no identifiable cause).
The CHMP conclusion stalk from a safety review conduct with the EMEA's Pharmacovigilance Working Party. This review integrated also a massive figure of non-centrally authorised medicines.
Implementation of the guidance for non-centrally authorised medicines will savour through the pertinent national procedures.
Notes 1. More information be unclaimed in a question-and-answer text.
2. Three angiotensin II receptor antagonists are within your rights in a minute available in centrally authorised medicines: irbesartan, telmisartan and valsartan.
3. Centrally authorised medicines contain Irbesartan are Aprovel, Karvea, Irbesartan BMS and Irbesartan Winthrop. Irbesartan is also available in mix with hydrochlorothiazide in the down centrally authorised medicines: Coaprovel, Karvezide, Irbesartan Hydrochlorothiazide BMS and Irbesartan Hydrochlorothiazide Winthrop.
4. Centrally authorised medicines containing telmisartan are Micardis, Pritor and Kinzalmono. Telmisartan is also available in combination with hydrochlorothiazide in the following centrally authorised medicines: MicardisPlus, PritorPlus and Kinzalkomb.
5. Valsartan is available in combination with amlodipine in the following centrally authorised medicines: Exforge, Copalia, Dafiro and Imprida.
European Medicines Agency
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