European Union - English - EMA (European Medicines Agency)

betapharm arzneimittel gmbh - azacitidine - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastic agents - azacitidine betapharm is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate-2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 % to 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 % to 30 % blasts and multi-lineage dysplasia, according to world health organization (who) classification,aml with > 30 % marrow blasts according to the who classification.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

medispec (m) sdn.bhd - donepezil hydrochloride -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

medispec (m) sdn.bhd - donepezil hydrochloride -

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

genepharm s.a., greece - desloratadine - film-coated tablet - 5 mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

genepharm s.a., greece - desloratadine - film-coated tablet - 5 mg

Malta - English - Medicines Authority

genepharm s.a. 18th klm marathonos ave. 15351, pallini, greece - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

Ireland - English - HPRA (Health Products Regulatory Authority)

betapharm arzneimittel gmbh - ambrisentan - film-coated tablet - 10 milligram(s) - other antihypertensives; ambrisentan

Ireland - English - HPRA (Health Products Regulatory Authority)

betapharm arzneimittel gmbh - ambrisentan - film-coated tablet - 5 milligram(s) - other antihypertensives; ambrisentan

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - amlodipine besilate, quantity: 3.5 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; magnesium stearate; maize starch; microcrystalline cellulose - hypertension - genepharm amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of genepharm amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin-converting enzyme inhibitor. angina - genepharm amlodipine is indicated for the first line treatment of chronic stable angina. genepharm amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - amlodipine besilate, quantity: 14 mg - tablet, uncoated - excipient ingredients: maize starch; lactose monohydrate; microcrystalline cellulose; magnesium stearate - hypertension - genepharm amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of genepharm amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin-converting enzyme inhibitor. angina - genepharm amlodipine is indicated for the first line treatment of chronic stable angina. genepharm amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs.