Malta - English - Medicines Authority

kwizda pharma gmbh effingergasse 21, vienna 1160, austria - thymi herba, althaeae radix - syrup - thymi herba 7.8 mg althaeae radix 55.3 mg - cough and cold preparations

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

sumitomo pharma america, inc. - allogeneic thymocyte-depleted thymus tissue-agdc (unii: xd66yk3yy3) (allogeneic thymocyte-depleted thymus tissue-agdc - unii:xd66yk3yy3) - rethymic® is indicated for immune reconstitution in pediatric patients with congenital athymia. limitations of use - rethymic is not indicated for the treatment of patients with severe combined immunodeficiency (scid). none. risk summary there are no clinical data with rethymic in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with rethymic. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of cellular components of rethymic in human milk, the effect breastfeeding may have on rethymic, the effect of being breastfed from a mother who received rethymic as a child, or the effects of rethymic on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for rethymic and potential adverse effects on the breastfed infant from rethymic. no nonclinical or clinical studies were performed to evaluate the effects of rethymic on fertility. the efficacy and safety of rethymic have been established in pediatric patients with congenital athymia. the efficacy of rethymic has been established in 95 pediatric patients (median age 9 months [range: 33 days to 3 years], including 65 patients age <1 year, 24 patients age 1 to <2 years, and 6 patients age 2 to <3 years at time of treatment) who were treated with rethymic and included in the analysis of efficacy [see clinical studies (14) ]. the safety of rethymic has been established in 105 pediatric patients (median age 9 months [range: 33 days to 16.9 years] at time of treatment) with congenital athymia who were evaluated for safety following rethymic administration. the safety population included 65 patients age <1 year, 27 patients age 1 to <2 years, 9 patients age 2 to <3 years, 1 patient age 3 to <6 years, and 3 patients age 13 to 17 years at time of treatment. within the safety population, survival was similar across age groups. adverse reactions were reported at similar frequencies across the age groups and were generally of similar types and severities. in the clinical studies with rethymic, 10 of 105 patients had impaired renal function at baseline based on elevated screening creatinine [see warnings and precautions (5.4)] . baseline renal function should be considered when selecting immunosuppressants. ensure appropriate involvement of a nephrologist in care of patients with renal impairment.

European Union - English - EMA (European Medicines Agency)

molmed spa - allogeneic t cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (Δlngfr) and the herpes simplex i virus thymidine kinase (hsv-tk mut2) - hematopoietic stem cell transplantation; graft vs host disease - antineoplastic agents - zalmoxis is indicated as adjunctive treatment in haploidentical haematopoietic stem cell transplantation (hsct) of adult patients with high-risk haematological malignancies.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

kwizda pharma gmbh - althaea officinalis l., root, liquid extract, water, 1-12_14 4,5 mg; thymus vulgaris l. - thymus zygis l (ph.eur. mixture), herb, dry extract, water, 7-13_1 51,1 mg - lozenge - thymi, herb, dry extract water 7-13_1 51.1 mg; althaeae, root, dry extract water 7-9_1 4.5 mg - combinations

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

dupharm store abu dhabi-sanaya m2 mussaffah - glycyrrhiza glabra, thymi liq.ext., evening primrose oil, anise oil, rosemary - syrup - combination - herbal remedy-n/a, respiratory system-bronchodilators

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

evening primrose water glycerin extract, anise seed water glycerin extract, thymi water glycerin extract, licorice water glycerin extract, rosemary leaf water glycerin extract -

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - tezepelumab - asthma - drugs for obstructive airway diseases, - tezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

eisai co., ltd. - lenvatinib mesilate - yellowish red/yellow capsule, full length: 14.3 mm, no.4 capsule

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

eisai co., ltd. - lenvatinib mesilate - yellowish red/yellow capsule, full length: 14.3 mm, no.4 capsule

Israel - English - Ministry of Health

abic marketing ltd, israel - fluorouracil - solution for injection - fluorouracil 50 mg/ml - fluorouracil - fluorouracil - palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas, in selected patients considered incurable by surgery or other means.as leucovorin-fluorouracil chemotherapy combination for cancer treatment.