Forosa

Glavne informacije

  • Zaščiteno ime:
  • Forosa 70 mg filmsko obložene tablete
  • Farmacevtska oblika:
  • filmsko obložena tableta
  • Sestava:
  • alendronska kislina 70 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla z 12 tabletami (3 x 4 tablet v pretisnem omotu)
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Forosa 70 mg filmsko obložene tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • alendronska kislina

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 5363-U-I-462/07
  • Datum dovoljenje:
  • 12-11-2012
  • EAN koda:
  • 3837000108002
  • Zadnja posodobitev:
  • 25-05-2018

Podatki za bolnike

NAVODILO ZA UPORABO

Forosa™ 70 mg filmsko obložene tablete

ALENDRONSKA KISLINA

Navodilo vsebuje:

1. Kaj je zdravilo Forosa in za kaj ga uporabljamo

2. Kaj morate vedeti, preden boste uporabili zdravilo Forosa

3. Kako uporabljati zdravilo Forosa

4. Možni neželeni učinki

5. Shranjevanje zdravila Forosa

6. Dodatne informacije

1. KAJ JE ZDRAVILO FOROSA IN ZA KAJ GA UPORABLJAMO

Alendronat spada v skupino nehormonskih zdravil, imenovanih difosfonati. Alendronat

preprečuje izgubljanje kostne mase, do katerega prihaja pri ženskah v obdobju po

menopavzi, in pomaga pri gradnji kosti. Alendronat zmanjšuje tveganje zlomov kosti.

Za kaj se uporablja zdravilo Forosa

Vaš zdravnik vam je predpisal zdravilo Forosa zato, ker imate obolenje, imenovano

osteoporoza.

Pri osteoporozi gre za tanjšanje in šibkost kosti. V glavnem se pojavlja pri ženskah po

menopavzi. V menopavzi jajčniki prenehajo tvoriti ženski hormon estrogen, ki pomaga

ohranjati zdravo okostje. Posledica tega je, da prihaja do izgubljanja kostne mase in kosti

postanejo šibkejše. Prej ko pri ženski nastopi menopavza, večje je tveganje, da pride do

osteoporoze.

V začetni fazi je osteoporoza v glavnem brez simptomov. Če je ne zdravimo, lahko privede

do zlomov kosti. Čeprav zlomi običajno povzročajo bolečine, se lahko zgodi, da zlomov

hrbteničnih kosti ne zaznamo, vse dokler ne privedejo do zmanjšanja telesne višine. Do

zlomov lahko pride med običajnimi vsakodnevnimi dejavnostmi, kot je dvigovanje, ali pa

zaradi poškodb, ki običajno ne povzročijo zloma normalne kosti. Praviloma prihaja do zlomov

kolka, hrbtenice ali zapestja. Poleg bolečin lahko ti zlomi povzročijo tudi znatno

deformiranost in nezmožnost (kot je na primer sključena drža ali grba in zmanjšana

gibljivost).

Kako je osteoporozo mogoče zdraviti?

Pomembno je, da se zavedamo, da je osteoporozo mogoče zdraviti in da za začetek

zdravljenja nikoli ni prepozno. Zdravnik vam je predpisal 70 mg tablete Forosa (enkrat

tedensko) za zdravljenje osteoporoze. Alendronat ne prepreči le izgubljanja kostne mase,

Pred uporabo natančno preberite navodilo!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.

Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi lahko celo

škodovalo, čeprav imajo znake bolezni, podobne vašim.

Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni

omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.

temveč tudi pomaga pri izgradnji kostne mase, ki ste jo izgubili, in tako zmanjša tveganje

zlomov kosti.

Poleg zdravljenja s 70 mg tabletami Forosa (enkrat tedensko) vam zdravnik lahko priporoči,

da spremenite svoj način življenja, kar lahko izboljša vaše zdravstveno stanje. Te

spremembe so:

Prenehanje kajenja

Zdi se, da kajenje povzroča hitrejše izgubljanje kostne mase in zato poveča tveganje zlomov.

Telesna dejavnost

Tako kot mišicam, je tudi kostem potrebna telesna dejavnost, da ostanejo močne in zdrave.

Preden začnete s kakršnimkoli programom telesne dejavnosti, se posvetujte z zdravnikom.

Uživanje uravnotežene hrane

Vaš zdravnik vam lahko svetuje, kako se prehranjujte in če so potrebni dodatki k hrani.

2. KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO FOROSA

Ne uporabljajte zdravila Forosa, če:

ste alergični (preobčutljivi) na alendronat ali katerokoli sestavino zdravila Forosa

imate določene okvare požiralnika

ne morete stati ali vzravnano sedeti najmanj 30 minut

vam je vaš zdravnik povedal, da imate v krvi premalo kalcija

mislite, da ste noseči ali ste zanesljivo noseči

dojite

Alendronata se ne sme dajati otrokom.

Če mislite, da karkoli od zgoraj naštetega velja tudi za vas, ne jemljite teh tablet. Najprej se

posvetujte z zdravnikom in se ravnajte po njegovem nasvetu.

Bodite posebno pozorni pri uporabi zdravila Forosa, če:

imate težave z ledvicami

imate kakršnokoli alergijo

imate težave s požiranjem ali prebavne težave

O teh stanjih obvestite tudi svojega zdravnika.

Povejte svojemu zdravniku, preden boste vzeli zdravilo Forosa :

če veste da imate Barret-ov požiralnik (stanje, povezano s spremembo celic v sluznici

spodnjega dela požiralnika).

Uporaba pri starejših

Zdravilo Forosa enako dobro prenašajo mlajši in starejši od 65 let.

Uporaba drugih zdravil

Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli

zdravilo, tudi če ste ga dobili brez recepta.

Zdravilo lahko reagira s hrano, pijačo ali drugimi zdravili, ki jih zaužijete. Pomembno je, da

upoštevate navodila navedena v poglavju 3. Kako uporabljati zdravilo Forosa.

Jemanje zdravila Forosa skupaj s hrano in pijačo

Pri jemanju alendronata lahko pride do medsebojnega delovanja s hrano, pijačo ali drugimi

zdravili, ki jih jemljete, zato je pomembno, da upoštevate navodila, ki so navedena v poglavju

3. Kako uporabljati zdravilo Forosa.

Nosečnost in dojenje

Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.

Alendronata med nosečnostjo in dojenjem ne smete jemati.

Vpliv na sposobnost upravljanja vozil in strojev

Ni dokazano, da bi alendronat zmanjševal vaše sposobnosti za vožnjo in upravljanje s stroji.

3. KAKO UPORABLJATI ZDRAVILO FOROSA

Pri uporabi zdravila Forosa natančno upoštevajte zdravnikova navodila. Če ste negotovi, se

posvetujte z zdravnikom ali s farmacevtom.

Morebiti so vam v preteklosti predpisali 10 mg tablete alendronata, ki jih je treba jemati

enkrat na dan. Zdravilo Forosa 70 mg tablete pa je treba jemati enkrat na teden.

Da bo jemanje zdravila Forosa za vas nedvomno koristno, morate upoštevati naslednja

priporočila.

Zelo pomembno je, da upoštevate navodila, navedena pod točkami 2, 3, 4 in 5. Tako bodo

Forosa tablete hitro prišle v želodec in zmanjšala se bo možnost, da bi prišlo do draženja

požiralnika.

V tednu izberite dan, ki vam najbolj ustreza. Vsak teden na izbrani dan vzemite eno 70

mg tableto Forosa.

Takoj ko zjutraj vstanete in preden zaužijete prvi obrok hrane ali pijače ali kakšno drugo

zdravilo, pogoltnite tableto Forosa s polnim kozarcem navadne vode (ne manj kot 2 dl).

Ne uporabljajte:

mineralne vode,

kave ali čaja,

soka.

Forosa tablete ne žvečite niti ne dopustite, da bi se v ustih raztopila.

Potem ko ste pogoltnili Forosa tableto ne smete ponovno leči - ostanite popolnoma

vzravnani (bodisi da sedite, stojite ali hodite) najmanj 30 minut; uležete se lahko šele po

zaužitju prvega obroka hrane v tistem dnevu.

Zdravila Forosa ne smete jemati zvečer pred spanjem ali preden zjutraj vstanete.

Če pride do težav ali bolečin pri požiranju, bolečin v prsih, če se na novo pojavi ali

poslabša zgaga, prenehajte jemati zdravilo Forosa in se posvetujte z zdravnikom.

Takoj ko ste pogoltnili Forosa tableto, počakajte najmanj 30 minut, preden zaužijete svoj

prvi obrok hrane, pijače ali vzamete kakšno drugo zdravilo tisti dan, vključno z antacidi,

kalcijevimi dodatki in vitamini. Alendronat je učinkovit le, če ga vzamete na prazen

želodec.

Če pozabite vzeti odmerek zdravila, vzemite 70 mg tableto Forosa naslednje jutro, takoj

ko se spomnite. Ne smete vzeti dveh tablet v enem dnevu. Nato pa spet jemljite po

eno tableto enkrat na teden, na dan, ki ste ga prvotno izbrali.

Pomembno je, da z jemanjem zdravila Forosa nadaljujete tako dolgo, kot vam je

predpisal zdravnik. Zdravilo Forosa lahko zdravi vašo osteoporozo samo, če ga uživate

redno.

Če menite, da je učinek zdravila Forosa premočan ali prešibak, se posvetujte z zdravnikom

ali s farmacevtom.

Če ste vzeli večji odmerek zdravila Forosa, kot bi smeli

Če ste pomotoma zaužili več tablet zdravila, popijte poln kozarec mleka in se takoj

posvetujte z zdravnikom. Ne poskušajte izzvati bruhanja. Prav tako ne smete leči.

Če ste pozabili vzeti zdravilo Forosa

Če ste pozabili vzeti odmerek zdravila, vzemite eno 70 mg tableto Forosa naslednje jutro,

takoj ko se spomnite. Ne smete vzeti dveh tablet v enem dnevu. Nato pa spet jemljite po

eno tableto enkrat na teden, na dan, ki ste ga prvotno izbrali.

Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali s

farmacevtom.

4. MOŽNI NEŽELENI UČINKI

Kot vsa zdravila ima lahko tudi zdravilo Forosa neželene učinke, ki pa se ne pojavijo pri vseh

bolnicah.

Neželeni učinki so običajno blagi, kljub temu pa lahko pri nekaterih bolnicah pride do

prebavnih motenj, ki so lahko hude. Te vključujejo draženje ali razjedo požiralnika, ki lahko

povzroči bolečine v prsih, zgago, težave ali bolečine pri požiranju in/ali praskanje, možno je

posledično zoženje požiralnika. Te reakcije se lahko pojavijo še posebej tedaj, kadar bolnice

z zdravilom Forosa ne popijejo polnega kozarca vode, če ležejo prej kot 30 minut po zaužitju

alendronata ali preden zaužijejo svoj prvi obrok hrane tisti dan. Spremembe požiralnika se

lahko še poslabšajo, če bolnice po razvoju simptomov, ki kažejo na draženje požiralnika, še

naprej jemljejo zdravilo Forosa.

Pogosti neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov):

razjeda požiralnika, težave pri požiranju, bolečine v trebuhu, prebavne motnje, zaprtje, driska,

vetrovi in občutek napihnjenosti, napet trebuh, vračanje (refluks) vsebine želodca v požiralnik,

bolečine v kosteh, mišicah in sklepih, glavobol.

Občasni neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov):

vnetje želodca, vnetje požiralnika, razjede (erozije) požiralnika, slabost, bruhanje, črno obarvano

blato, izpuščaji, srbenje, rdečica.

Redki neželeni učinki (pojavijo se pri 1 do 10 bolnikih od 10.000 bolnikov):

zožitev požiralnika, razjede v požiralniku in v ustih, predrtja (perforacije), razjede in krvavitve

v zgornjem delu prebavil (čeprav ni znano ali te razjede povzroča alendronska kislina),

preobčutljivostne (alergijske) reakcije vključno s srbečimi izpuščaji in otekanjem (kar lahko

povzroči težave pri dihanju in požiranju), kožni izpuščaji s preobčutljivostjo za svetlobo,

zmanjšana raven kalcija v krvi, bolečine v očeh, zmanjšan ali zamegljen vid in/ali pojavljanje

črnih lebdečih pik pred očmi.

Na začetku zdravljenja se lahko pojavijo prehodni znaki, kot so bolečine v mišicah, splošna

oslabelost in povišana telesna temperatura.

Redko se lahko pojavijo neobičajni zlomi stegnenice, še posebno pri bolnikih, ki so na

dolgotrajnem zdravljenju osteoporoze . Posvetujte se z zdravnikom, če občutite bolečine,

šibkost ali nelagodje v stegnu, kolku ali dimljah, saj so to lahko zgodnji znaki možnega zloma

stegnenice.

Zelo redki neželeni učinki (pojavijo se pri manj kot 1 bolniku od 10.000 bolnikov):

Opazili so posamezne primere hudih kožnih reakcij.

Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni

omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.

5. SHRANJEVANJE ZDRAVILA FOROSA

Zdravilo shranjujte nedosegljivo otrokom!

Za shranjevanje zdravila niso potrebna posebna navodila.

Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.

Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.

Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke. O načinu

odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom. Takšni ukrepi

pomagajo varovati okolje.

6. DODATNE INFORMACIJE

Kaj vsebuje zdravilo Forosa

Zdravilna učinkovina je alendronska kislina. Ena filmsko obložena tableta vsebuje

91,350 mg natrijevega alendronata, kar ustreza 70 mg alendronske kisline.

Pomožne snovi so:

jedro: mikrokristalna celuloza, brezvodni koloidni silicijev dioksid, premreženi natrijev

karmelozat, magnezijev stearat

obloga: mikrokristalna celuloza, karagenan in makrogol 8000

Izgled zdravila Forosa in vsebina pakiranja

Bele, okrogle, bikonveksne filmsko obložene tablete, z oznako »ALN 70« na eni strani.

Zdravilo je na voljo v škatlah s 4 (1 x 4 tablete v pretisnem omotu), 8 (2 x 4 tablete v

pretisnem omotu) ali 12 (3 x 4 tablete v pretisnem omotu) filmsko obloženimi tabletami.

Način in režim izdaje zdravila Forosa

Izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom

Kemofarmacija d.d., Ljubljana, Cesta na Brdo 100, Ljubljana, Slovenija

Izdelovalec

Lek farmacevtska družba d.d., Verovškova 57, Ljubljana, Slovenija

Navodilo je bilo odobreno

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Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Health Canada's sampling and evaluation program has determined the Super Cool Slime products donot meet the Canadian toy safety requirements related to boric acid content.

Health Canada

14-8-2018

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Health Canada’s sampling and evaluation program has determined the Do-It-Yourself Slime Kits do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30

Europe -DG Health and Food Safety

3-7-2018

Granupas (Eurocept International B.V.)

Granupas (Eurocept International B.V.)

Granupas (Active substance: Para-aminosalicylic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4256 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2709/T/25

Europe -DG Health and Food Safety

27-6-2018

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Active substance: (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3,4-dihydro-4-quinazolinyl} acetic acid) - Transfer of orphan designation - Commission Decision (2018)4102 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/10/T/02

Europe -DG Health and Food Safety

19-6-2018

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Active substance: oxalic acid dihydrate) - Centralised - Authorisation - Commission Decision (2018)3892 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4667

Europe -DG Health and Food Safety

4-6-2018

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Active substance: chenodeoxycholic acid) - Centralised - Yearly update - Commission Decision (2018)3627 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (Active substance: Poly[2-[(4-{[1-carboxy-2-(hexadecylcarbamoyl)ethyl]sulfanyl}-2,3-bis({2-[((2S)-2-(2-{[(2R)-2-carbamoyl-(2-{[(2S)-1-ethoxy-3-(3-hydroxy-4oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}ethyl]sulfanyl}-3-{[(2S)-1-ethoxy-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}propanamido)-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)propanoyl Ethyl ester) )-methoxy]acetyl}oxy)butyl)sulfanyl]-3-(hexadecylcarbamoyl)propanoic acid]-poly(ethylene glycol)-este...

Europe -DG Health and Food Safety

15-5-2018

Orphacol (Laboratoires CTRS)

Orphacol (Laboratoires CTRS)

Orphacol (Active substance: Cholic acid) - Centralised - Yearly update - Commission Decision (2018)3061 of Tue, 15 May 2018

Europe -DG Health and Food Safety