European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - thalidomide - multiple myeloma - immunosuppressants - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy.thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.4).

European Union - English - EMA (European Medicines Agency)

lipomed gmbh - thalidomide - multiple myeloma - immunosuppressants - thalidomide lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.thalidomide lipomed is prescribed and dispensed in accordance with the thalidomide lipomed pregnancy prevention programme (see section 4.4).

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - thalidomide - hard capsule - thalidomide 50 mg - immunosuppressants

Israel - English - Ministry of Health

neopharm ltd - thalidomide - hard capsule - thalidomide 50 mg - thalidomide - multiple myeloma : * for the treatment of multiple myeloma after failure of standard therapies. * thalidomide bms 50 mg hard capsules in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma. * thalidomide bms in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma > or = 65 years or ineligible for high dose chemotherapy. erythema nodosum leprosum: for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (enl). thalidomide is not indicated as monotherapy for such enl treatment in the presence of moderate to severe neuritis. it is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of enl recurrence.

Israel - English - Ministry of Health

neopharm ltd - thalidomide - hard capsule - thalidomide 50 mg - thalidomide - multiple myeloma : 1. for the treatment of multiple myeloma after failure of standars therapies. 2. thalidomide celgene 50 mg hard capsules in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma. 3. thalidomide celgene in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma > or = 65 years or ineligible for high dose chemotherapy. erythema nodosum leprosum: 4. for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (enl). thalidomide is not indicated as monotherapy for such enl treatment in the presence of moderate to severe neuritis. it is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of enl recurrence.בקשה לעדכון משטר מינון 4/2/2020

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

celgene pty ltd - thalidomide, quantity: 100 mg - capsule, hard - excipient ingredients: magnesium stearate; pregelatinised maize starch; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; gelatin; sodium lauryl sulfate - multiple myeloma - thalomid in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma aged 65 years and over or ineligible for high dose chemotherapy. thalomid in combination with dexamethasone is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for the treatment of patients with untreated multiple myeloma. thalomid, as monotherapy, is indicated for the treatment of multiple myeloma after failure of standard therapies. erythema nodosum leprosum (enl). thalomid is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (enl). thalomid is not indicated as monotherapy for such enl treatment in the presence of moderate to severe neuritis. thalomid is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of enl recurrence. thalomid is prescribed and dispensed through the thalidomide risk management pro

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

celgene ltd - thalidomide - capsule - 50mg

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

celgene australia pty ltd - thalidomide -

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

celgene pty ltd - thalidomide, quantity: 50 mg - capsule, hard - excipient ingredients: magnesium stearate; pregelatinised maize starch; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; gelatin - multiple myeloma - thalomid in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma aged 65 years and over or ineligible for high dose chemotherapy. thalomid in combination with dexamethasone is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for the treatment of patients with untreated multiple myeloma. thalomid, as monotherapy, is indicated for the treatment of multiple myeloma after failure of standard therapies. erythema nodosum leprosum (enl). thalomid is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (enl). thalomid is not indicated as monotherapy for such enl treatment in the presence of moderate to severe neuritis. thalomid is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of enl recurrence. multiple myeloma - thalomid in combination with melphalan and prednisone is indi

United States - English - NLM (National Library of Medicine)

celgene corporation - thalidomide (unii: 4z8r6ors6l) (thalidomide - unii:4z8r6ors6l) - thalidomide 50 mg - thalomid in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (mm) [see clinical studies (14.1)] . thalomid is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (enl). thalomid is not indicated as monotherapy for such enl treatment in the presence of moderate to severe neuritis. thalomid is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of enl recurrence [see clinical studies (14.2)]. thalomid is contraindicated in females who are pregnant. thalomid can cause fetal harm when administered to a pregnant female [see boxed warning, warnings and precautions (5.1) and use in specific populations (8.1)] . thalomid is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects, even after a single dose [see boxed warning] . mortality at or shortly after birth has been reported in about 40% of infants.