Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

imported (south africa) - puff adder snake venom antiserum; gaboon adder snake venom antiserum; rinkhals cobra snake venom antiserum; green mamba snake venom antiserum; jameson's mamba snake venom antiserum; black mamba snake venom antiserum; cape cobra snake venom antiserum; forest cobra snake venom antiserum; egyptian cobra snake venom antiserum; black necked spitting cobra snake venom antiserum - solution for injection

Singapur - angielski - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - hematology - it is intended for use in the direct antiglobulin test (dat) to identify the immunoglobulin and/or complement that coat the red cells in vivo. the id-card “dc-screening i” consists of monospecific antihuman globulin (ahg) reagents: anti-igg, anti-iga,anti-igm, anti-c3c and anti-c3d suspended in gel; and an isotonic salt solution as the negative control.

Unia Europejska - angielski - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - carcinoma, non-small-cell lung - antineoplastic agents - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Unia Europejska - angielski - EMA (European Medicines Agency)

roche registration gmbh  - glofitamab - lymphoma, large b-cell, diffuse - antineoplastic agents - columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b cell lymphoma (dlbcl), after two or more lines of systemic therapy.

Unia Europejska - angielski - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - epcoritamab - lymphoma, large b-cell, diffuse - antineoplastic agents - tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) after two or more lines of systemic therapy.

Irlandia - angielski - HPRA (Health Products Regulatory Authority)

optrex limited - naphazoline hydrochloride; hamamelis water - eye drops, solution - 12.5/0.01 percent weight/volume - sympathomimetics used as decongestants; naphazoline, combinations

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

akorn - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug in 0.1 g - fluticasone propionate nasal spray, usp is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. fluticasone propionate nasal spray, usp is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.3), description (11) ]. risk summary there are insufficient data on the use of fluticasone propionate in pregnant women to inform a drug-associated risk. in animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, were observed in rats, mice, and rabbits with subcutaneously administered maternal toxic doses of fluticasone propionate 5 times, equivalent to, and less than the maximum recommended human daily intranasal dose (mrhdid) on a mcg/m2 basis, respectively. (see animal data .) however, fluticasone propionate administered via nose-only inhalation to rats decreased fetal body weight, but did not induce teratogenicit

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

asclemed usa, inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate nasal spray, usp is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. fluticasone propionate nasal spray, usp is contraindicated in patients with hypersensitivity to any of its ingredients [ see warnings and precautions (5.3) , description (11) ]. risk summary there are insufficient data on the use of fluticasone propionate in pregnant women to inform a drug-associated risk. in animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, were observed in rats, mice, and rabbits with subcutaneously administered maternal toxic doses of fluticasone propionate 5 times, equivalent to, and less than the maximum recommended human daily intranasal dose (mrhdid) on a mcg/m 2 basis, respectively. ( see animal data .) however, fluticasone propionate administered via

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

advanced rx pharmacy of tennessee, llc - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate nasal spray, usp is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. fluticasone propionate nasal spray, usp is contraindicated in patients with hypersensitivity to any of its ingredients [seewarnings and precautions (5.3), description (11)]. 8.1 pregnancy risk summary there are insufficient data on the use of fluticasone propionate in pregnant women to inform a drug-associated risk. in animals, teratogenicity characteristic of corticosteroids, decreased fetal body weight and/or skeletal variations, were observed in rats, mice, and rabbits with subcutaneously administered maternal toxic doses of fluticasone propionate 5 times, equivalent to, and less than the maximum recommended human daily intranasal dose (mrhdid) on a mcg/m2 basis, respectively. (see animal data.) however, fluticasone propionate administered via nose-only inhalation to rats decreased fetal body weight, but did not induce terato

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

h. j. harkins company inc. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings and precautions (5.1)], reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. tramadol hydrochloride extended-release tablets are contraindicated for: all children younger than 12 years of age [see warnings and precautions (5.3)] post-ope