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

merck serono ltd - metformin hydrochloride - modified-release tablet - 500mg

European Union - English - EMA (European Medicines Agency)

merck europe b.v. - avelumab - neuroendocrine tumors - other antineoplastic agents, monoclonal antibodies - bavencio is indicated as monotherapy for the treatment of adult patients with metastatic merkel cell carcinoma (mcc).bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (rcc).bavencio is indicated as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc) who are progression-free following platinum‑based chemotherapy.

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

merck serono australia pty ltd - metacresol,somatropin,water for injections -

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

emd serono, inc. - cladribine (unii: 47m74x9yt5) (cladribine - unii:47m74x9yt5) - mavenclad is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include relapsing-remitting disease and active secondary progressive disease, in adults. because of its safety profile, use of mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of ms [see warnings and precautions (5)]. limitations of use mavenclad is not recommended for use in patients with clinically isolated syndrome (cis) because of its safety profile [see warnings and precautions (5)]. mavenclad is contraindicated: - in patients with current malignancy [see warnings and precautions (5.1)]. - in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception during mavenclad dosing and for 6 months after the last dose in each treatment course. may cause fetal harm [see warnings and precautions (5.2) and use in specific populations (8.1, 8.3)] . - in patients infected with the human immunodeficiency virus (hiv) [see warnings and precautions (5.4)]. - in patients with active chronic infections (e.g., hepatitis or tuberculosis) [see warnings and precautions (5.4)]. - in patients with a history of hypersensitivity to cladribine [see warnings and precautions (5.8)]. - in women intending to breastfeed on a mavenclad treatment day and for 10 days after the last dose [see use in specific populations (8.2)]. risk summary mavenclad is contraindicated in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception. there are no adequate data on the developmental risk associated with use of mavenclad in pregnant women. cladribine was embryolethal when administered to pregnant mice and produced malformations in mice and rabbits [see data] . the observed developmental effects are consistent with the effects of cladribine on dna [see contraindications (4) and warnings and precautions (5.2)]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. there is a pregnancy safety study that monitors the pregnancy and infant outcomes following exposure to cladribine. physicians and patients are encouraged to report pregnancies of women with multiple sclerosis exposed to oral cladribine during pregnancy or within 6 months before conception as well as pregnancies fathered by men with multiple sclerosis who had taken oral cladribine within 6 months before conception by calling emd serono's adverse event reporting line at 1-800-283-8088 ext. 5563 or by faxing 1-781-681-2961. data animal data when cladribine was administered intravenously (0, 0.5, 1.5, or 3 mg/kg/day) to pregnant mice during the period of organogenesis, fetal growth retardation and malformations (including exencephaly and cleft palate) and embryofetal death were observed at the highest dose tested. an increase in skeletal variations was observed at all but the lowest dose tested. there was no evidence of maternal toxicity. when cladribine was administered intravenously (0, 0.3, 1, and 3 mg/kg/day) to pregnant rabbits during the period of organogenesis, fetal growth retardation and a high incidence of craniofacial and limb malformations were observed at the highest dose tested, in the absence of maternal toxicity. when cladribine was administered intravenously (0, 0.5, 1.5, or 3.0 mg/kg/day) to mice throughout pregnancy and lactation, skeletal anomalies and embryolethality were observed at all but the lowest dose tested. risk summary mavenclad is contraindicated in breastfeeding women because of the potential for serious adverse reactions in breastfed infants [see contraindications (4) and warnings and precautions (5)] . advise women not to breastfeed during dosing with mavenclad and for 10 days after the last dose. there are no data on the presence of cladribine in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. pregnancy testing in females of reproductive potential, pregnancy should be excluded before the initiation of each treatment course of mavenclad [see use in specific populations (8.1)]. contraception females females of reproductive potential should prevent pregnancy by use of effective contraception during mavenclad dosing and for at least 6 months after the last dose in each treatment course. women who become pregnant during mavenclad therapy should discontinue treatment [see warnings and precautions (5.2)]. males as cladribine interferes with dna synthesis, adverse effects on human gametogenesis could be expected. therefore, male patients of reproductive potential should take precautions to prevent pregnancy of their partner during mavenclad dosing and for at least 6 months after the last dose in each treatment course [see warnings and precautions (5.2) and nonclinical toxicology (13.1)]. the safety and effectiveness in pediatric patients (below 18 years of age) have not been established. use of mavenclad is not recommended in pediatric patients because of the risk of malignancies [see warnings and precautions (5.1)]. clinical studies with mavenclad did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. caution is recommended when mavenclad is used in elderly patients, taking into account the potential greater frequency of decreased hepatic, renal, or cardiac function, concomitant diseases, and other drug therapy. the concentration of cladribine is predicted to increase in patients with renal impairment [see clinical pharmacology (12.3)]. no dosage adjustment is recommended in patients with mild renal impairment (creatinine clearance 60 to 89 ml per minute). mavenclad is not recommended in patients with moderate to severe renal impairment (creatinine clearance below 60 ml per minute) [see clinical pharmacology (12.3)]. the effect of hepatic impairment on the pharmacokinetics of cladribine is unknown [see clinical pharmacology (12.3)]. no dosage adjustment is recommended in patients with mild hepatic impairment. mavenclad is not recommended in patients with moderate to severe hepatic impairment (child-pugh score greater than 6) [see clinical pharmacology (12.3)].

Malta - English - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - hydrochlorothiazide, bisoprolol fumarate - film-coated tablet - bisoprolol fumarate 5 mg hydrochlorothiazide 12.5 mg - beta blocking agents

Malta - English - Malta Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - hydrochlorothiazide, bisoprolol fumarate - film-coated tablet - hydrochlorothiazide 25 mg bisoprolol fumarate 10 mg - beta blocking agents

Israel - English - Ministry of Health

merck serono ltd - cladribine - tablets - cladribine 10 mg - cladribine - mavenclad 10mg tablets is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (ms) as defined by clinical or imaging features

Israel - English - Ministry of Health

merck serono ltd - cladribine - tablets - cladribine 10 mg - cladribine - mavenclad 10mg tablets is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (ms) as defined by clinical or imaging features

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

merck serono europe ltd, united kingdom - progesterone - vaginal gel - 8 %

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

tabuk pharmaceutical manufacturing co., saudi arabia - palonosetron hydrochloride - solution - 0.05 mg/ml