Actonel

Glavne informacije

  • Zaščiteno ime:
  • Actonel Combi 35 mg + 1000 mg/880 i.e. filmsko obložene tablete + šumeča zrnca
  • Farmacevtska oblika:
  • filmsko obložena tableta in šumeča zrnca
  • Sestava:
  • risedronska kislina 32,5 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s 4 x (1 filmsko obložena tableta + 6 vrečk s šumečimi zrnci)
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Actonel Combi 35 mg + 1000 mg/880 i.e. filmsko obložene tablete + šumeča zrnca
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • risedronska kislina, kalcij in holekalciferol, zaporedni

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:
  • 103-142/2014-2
  • Datum dovoljenje:
  • 26-11-2014
  • EAN koda:
  • 3837000108255
  • Zadnja posodobitev:
  • 18-01-2018

Podatki za bolnike

JAZMP-IA/051/G-01. 12. 2015

Navodilo za uporabo

Actonel Combi 35 mg + 1.000 mg / 880 i.e. filmsko obložene tablete + šumeča zrnca

natrijev risedronat + kalcij / holekalciferol

Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne

podatke!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom ali 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 opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.

Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu.

Glejte poglavje 4.

Kaj vsebuje navodilo

Kaj je zdravilo Actonel Combi in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Actonel Combi

Kako jemati zdravilo Actonel Combi

Možni neželeni učinki

Shranjevanje zdravila Actonel Combi

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Actonel Combi in za kaj ga uporabljamo

Kaj je zdravilo Actonel Combi

Vsako tedensko pakiranje zdravila vsebuje kombinacijo 1 Actonel tablete in 6 vrečic s

kalcijem/vitaminom D

Actonel tablete

Actonel tablete vsebujejo natrijev risedronat, ki spada v skupino bisfosfonatov, nehormonskih zdravil,

ki jih uporabljamo za zdravljenje bolezni kosti. Deluje neposredno na kosti, jih krepi in tako zmanjšuje

verjetnost zlomov.

Kost je živo tkivo. Stara kostnina se iz okostja nenehno odstranjuje in nadomešča jo nova.

Pomenopavzna osteoporoza je stanje, ki se pojavi pri ženskah po menopavzi in povzroči, da kosti

postanejo šibkejše, bolj krhke in se ob padcu ali obremenitvi hitreje zlomijo.

Najpogostejši so zlomi hrbtenice, kolka in zapestja, vendar se lahko zlomi tudi katerakoli druga kost v

telesu. Posledica osteoporoze so lahko tudi bolečine v hrbtu, zmanjšanje telesne višine in ukrivljenost

hrbtenice. Številne bolnice z osteoporozo nimajo nobenih simptomov in možno je, da sploh niste

vedeli, da jo imate.

Vrečice s kalcijem/vitaminom D

3

Vrečice vsebujejo kalcij/vitamin D

v obliki šumečih zrnc, ki zagotavljajo kalcij in vitamin D

, ki ju

telo lahko potrebuje za utrditev nove kostnine.

Za kaj uporabljamo zdravilo Actonel Combi

Zdravljenje osteoporoze, tudi hude, pri

ženskah po menopavzi

, ki po presoji zdravnika potrebujejo

tudi dnevno

dodajanje kalcija in vitamina D

3

. Zdravilo zmanjša tveganje zlomov hrbtenice in kolka.

JAZMP-IA/051/G-01. 12. 2015

2.

Kaj morate vedeti, preden boste vzeli zdravilo Actonel Combi

Ne jemljite zdravila Actonel Combi

Če ste

alergični

na natrijev risedronat, kalcijev karbonat, vitamin D

, arašide ali sojo, ali

katero koli sestavino tega zdravila (navedeno v poglavju 6).

Če vam je zdravnik povedal, da imate:

hipokalcemijo

(znižano koncentracijo kalcija v krvi),

hiperkalcemijo

(zvišano koncentracijo kalcija v krvi),

hiperkalciurijo

(povečano izločanje kalcija z urinom)

,

hipervitaminozo D

(zvišano koncentracijo vitamina D v krvi).

Če bi lahko bili

noseči

, ste noseči ali nameravate zanositi.

dojite

Če imate

hude težave z ledvicami

, vključno z ledvičnimi kamni.

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila Actonel Combi se posvetujte s svojim zdravnikom ali s

farmacevtom.

Če ne morete biti pokonci (sedeti ali stati) vsaj 30 minut.

Če imate moteno presnovo kosti in mineralov (npr. pomanjkanje vitamina D, nepravilnosti

obščitničnih hormonov; oboje povzroči nizko koncentracijo kalcija v krvi).

Če imate ali ste kdaj imeli težave s požiralnikom (prehodom, ki usta povezuje z želodcem).

Morda se vam ali so se vam pojavljale, npr. bolečine ali težave pri požiranju hrane ali vam je

bilo predhodno rečeno, da imate Barrettov požiralnik (stanje, ki je povezano s spremembami

celic v spodnjem delu požiralnika).

Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje.

Če imate sarkoidozo (bolezen imunskega sistema, ki v glavnem prizadene pljuča in povzroči

težko dihanje ter kašelj).

Če že jemljete dodatke vitamina D.

Če imate ali ste kdaj imeli bolečo, oteklo ali omrtvelo čeljust, občutek “težke čeljusti” ali

razmajanost zoba.

Če se trenutno zdravite pri zobozdravniku ali imate predviden kirurški poseg v ustni votlini,

morate zobozdravniku povedati, da jemljete zdravilo Actonel Combi.

Če imate kaj od naštetega, vam bo zdravnik svetoval, kaj storiti pri jemanju zdravila Actonel Combi.

Otroci in mladostniki

Natrijevega risedronata ni priporočljivo uporabljati pri otrocih, mlajših od 18 let, ker o njegovi

varnosti in učinkovitosti ni dovolj podatkov.

Druga zdravila in zdravilo Actonel Combi

Actonel tablete

Učinek Actonel tablete se zmanjša pri sočasnem jemanju zdravil, ki vsebujejo katero od naslednjih

snovi:

kalcij,

magnezij,

aluminij (npr. v nekaterih pripravkih proti prebavnim težavam),

železo.

Takšna zdravila vzemite najmanj 30 minut po zaužitju tablete Actonel.

Vrečice s kalcijem/vitaminom D

3

Za zdravila, ki vsebujejo kalcij/vitamin D

je znano, da medsebojno delujejo z naslednjimi zdravili:

digitalisom (uporabljamo ga pri zdravljenju bolezni srca),

tetraciklinskimi antibiotiki,

kortikosteroidi (npr. kortizon),

natrijevim fluoridom (uporabljamo ga za krepitev zobne sklenine),

tiazidnimi diuretiki (uporabljamo jih za povečanje izločanja urina in s tem vode iz telesa),

JAZMP-IA/051/G-01. 12. 2015

holestiraminom (uporabljamo ga za zdravljenje visokih vrednosti holesterola v krvi),

odvajali (npr. parafinsko olje).

Če jemljete katerokoli od navedenih zdravil, vam bo zdravnik dal dodatna navodila.

Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda

začeli jemati katero koli drugo zdravilo.

Zdravilo Actonel Combi skupaj s hrano in pijačo

Actonel tablete

Za pravilno delovanje zdravila je zelo pomembno, da tablet Actonel NE JEMLJETE skupaj s hrano ali

pijačo (razen navadno vodo). Tablete še posebej ne smete vzeti skupaj z mlečnimi izdelki (npr. z

mlekom), ker ti izdelki vsebujejo kalcij (glejte poglavje 2, “Druga zdravila in zdravilo Actonel

Combi”).

Hrano in pijače (razen navadne vode) zaužijte vsaj 30 minut po zaužitju tablete Actonel.

Vrečice s kalcijem/vitaminom D

3

Raztopljenih zrnc kalcija/vitamina D

NE JEMLJITE skupaj s hrano, ki je bogata z oksalno kislino

(špinača in rabarbara) ali fitično kislino (polnozrnate žitarice). Raztopljena zrnca vzemite vsaj 2 uri po

uživanju tovrstne hrane.

Nosečnost in dojenje

NE JEMLJITE zdravila Actonel Combi, če ste noseči, menite, da bi lahko bili noseči ali načrtujete

zanositev (glejte poglavje 2, “Ne jemljite zdravila Actonel Combi”). Možno tveganje, povezano z

uporabo natrijevega risedronata (zdravilne učinkovine v tabletah Actonel) pri nosečnicah, ni znano.

NE JEMLJITE zdravila Actonel Combi, če dojite (glejte poglavje 2, “Ne jemljite zdravila

Actonel Combi”).

Vpliv na sposobnost upravljanja vozil in strojev

Ni znano, da bi zdravilo Actonel Combi vplivalo na sposobnost upravljanja vozil in strojev.

Pomembne informacije o nekaterih sestavinah zdravila Actonel Combi

Tablete vsebujejo laktozo. Šumeča zrnca vsebujejo sorbitol, saharozo in sojino olje (glejte poglavje 2,

»Opozorila in previdnostni ukrepi« in »Ne jemljite zdravila Actonel Combi«).

Vrečica zrnc kalcija/vitamina D

vsebuje kalij (163 mg na vrečico). To morajo upoštevati bolnice, ki

imajo zmanjšano delovanje ledvic ali bolnice, ki so na dieti z nadzorovanim vnosom kalija.

3.

Kako jemati zdravilo Actonel Combi

Pakiranje zdravila Actonel Combi za enotedensko zdravljenje vsebuje 1 tableto (v pretisnem omotu) in

6 vrečic šumečih zrnc, ki jih je treba uporabljati posebej. Vsaka škatla z zdravilom za enotedensko

zdravljenje ima na hrbtni strani navodila.

Pri jemanju tega zdravila natančno upoštevajte navodila svojega zdravnika ali farmacevta. Če ste

negotovi, se posvetujte s svojim zdravnikom ali farmacevtom.

Priporočeni odmerek:

Tedenski cikel:

dan 1: Actonel tableta (svetlooranžna tableta)

Vzemite ENO Actonel tableto enkrat na teden.

Izberite dan v tednu, ki najbolj ustreza vašemu urniku. To bo dan 1 tedenskega cikla. Vsak

teden vzemite Actonel tableto na izbrani dan 1.

dan 2 - 7: Vrečice s kalcijem/vitaminom D

3

(šumeča zrnca)

Z jemanjem začnite naslednji dan, ko ste vzeli Actonel tableto.

JAZMP-IA/051/G-01. 12. 2015

Naslednjih 6 dni vsak dan vzemite vsebino ENE vrečice zrnc s kalcijem/vitaminom D

Vsakih 7 dni začnite jemati zdravilo iz nove škatle za enotedensko zdravljenje. Pri tem na izbrani dan

1 vedno najprej vzemite Actonel tableto.

Actonel tableto in vsebino vrečice NE SMETE VZETI na isti dan.

KDAJ vzeti tableto Actonel

Tableto Actonel vzemite vsaj 30 minut prej, preden tisti dan zaužijete prvo hrano, pijačo (razen

navadne vode) ali kakšno drugo zdravilo.

KAKO jemati zdravilo Actonel Combi

Actonel tablete

Tableto vzemite v

pokončnem položaju

(lahko sedite ali stojite), da boste preprečili težave z

zgago.

Pogoltnite jo

z vsaj enim

kozarcem

(120 ml)

navadne vode

Tableto pogoltnite celo.

Ne smete jo sesati ali žvečiti.

Ne ulezite se prej kot 30 minut po

zaužitju tablete.

Vrečice s kalcijem/vitaminom D

3

Vsebino vrečice stresite v kozarec navadne vode in premešajte. Počakajte, da šumenje preneha in

raztopino nato popijte.

Če ste vzeli večji odmerek zdravila Actonel Combi, kot bi smeli

Actonel tablete

Če ste vzeli večji

odmerek

kot bi smeli, ali če je zdravilo slučajno vzel otrok ali kaka druga oseba,

popijte/naj popije

poln kozarec mleka

poišč(it)e zdravniško pomoč

Vrečice s kalcijem/vitaminom D

3

Če ste vzeli večji odmerek zdravila, kot bi smeli, ali če je zdravilo slučajno vzel otrok, se o tveganju in

potrebnih ukrepih posvetujte s svojim zdravnikom.

Če ste pozabili vzeti zdravilo Actonel Combi

Actonel tablete

Če ste pozabili vzeti tableto na izbrani dan (dan 1):

Tableto vzemite tisti dan, ko se spomnite. NE VZEMITE dveh tablet v enem dnevu, da bi tako

nadomestili pozabljeno tableto.

Naslednji dan vzemite vsebino vrečice s kalcijem/vitaminom D

. Actonel tableto in vsebine

vrečice NE SMETE VZETI isti dan.

Nadaljujte z jemanjem vsebine ene vrečice na dan do konca tedenskega cikla.

Ob koncu tedenskega cikla zavrzite vse neporabljene vrečice v škatli.

Nato začnite nov tedenski cikel: na izbrani dan 1 vzemite eno Actonel tableto enkrat na teden.

Vrečice s kalcijem/vitaminom D

3

Če ste pozabili vzeti vsebino vrečice s kalcijem/vitaminom D

Vsebino ene vrečice vzemite tisti dan, ko se spomnite. Vsebine vrečice NE SMETE VZETI isti

dan kot Actonel tableto. Na isti dan NE SMETE VZETI vsebine dveh vrečic.

Nadaljujte z jemanjem vsebine ene vrečice do konca tedenskega cikla.

Ob koncu tedenskega cikla zavrzite vse neporabljene vrečice v škatli.

Če ste prenehali jemati zdravilo Actonel Combi

Če zdravljenje prekinete, lahko začnete izgubljati kostno maso. Preden se odločite za prekinitev

zdravljenja, se posvetujte z zdravnikom.

Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom ali farmacevtom.

JAZMP-IA/051/G-01. 12. 2015

4.

Možni neželeni učinki

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

Actonel tablete

Če opazite karkoli od naslednjega,

takoj nehajte jemati Actonel tablete in se nemudoma posvetujte

s svojim zdravnikom

Simptomi, značilni za resno alergično reakcijo kot:

otekanje obraza, jezika ali žrela,

težave pri požiranju,

koprivnica in težave pri dihanju.

Hude kožne reakcije pri katerih se lahko pojavi mehurjenje kože.

Če opazite kateri koli naslednji neželeni učinek,

o njem takoj obvestite svojega zdravnika

Vnetje očesa, običajno z bolečino, pordelostjo in občutljivostjo na svetlobo.

Kostna nekroza čeljustnice (osteonekroza), povezana s počasnim celjenjem in okužbo, ki se

pogosto pojavijo po izruvanju zoba (glejte poglavje 2, “Opozorila in previdnostni ukrepi”).

Simptomi iz požiralnika kot so bolečina pri požiranju, težave pri požiranju, bolečina v prsih ali

nov pojav oz. poslabšanje zgage.

Redko

lahko

pojavi

nenavaden

zlom

stegnenice,

predvsem

bolnikih

dolgotrajnem

zdravljenju za osteoporozo. Če se vam pojavijo bolečine, šibkost ali nelagodje v stegnu, kolku ali

dimljah, se morate posvetovati s svojim zdravnikom, kajti to so lahko zgodnji znaki možnega zloma

stegnenice.

Drugi neželeni učinki, ki so jih ugotovili v kliničnih študijah, so bili običajno blagi in zaradi njih

zdravljenja ni bilo treba prekiniti.

Pogosti neželeni učinki

(pojavijo se lahko pri največ 1 od 10 bolnikov)

Prebavne težave, siljenje na bruhanje, bolečine v trebuhu, trebušni krči ali nelagodje, zaprtje,

občutek polnosti, napenjanje, driska.

Bolečine v kosteh, mišicah ali sklepih.

Glavobol.

Občasni neželeni učinki

(pojavijo se lahko pri največ 1 od 100 bolnikov)

Vnetje ali razjeda požiralnika (prehoda, ki usta povezuje z želodcem) s posledičnim

težkim in bolečim požiranjem (glejte tudi poglavje 2, “Opozorila in previdnostni ukrepi”),

vnetje želodca in dvanajstnika (del črevesa, v katerega se prazni želodec).

Vnetje obarvanega dela očesa (šarenice) (rdeče, boleče oči z možno spremembo vida).

Redki neželeni učinki

(pojavijo se lahko pri največ 1 od 1.000 bolnikov)

Vnetje jezika (pordel, otekel in lahko boleč), zožitev požiralnika (prehoda, ki usta povezuje z

želodcem).

Poročali so o nenormalnih izvidih jetrnih testov. Te je mogoče ugotoviti samo s preiskavo krvi.

Med pomarketinško uporabo so bile opisane naslednje dodatne neželene reakcije:

Zelo redki: V primeru bolečine v ušesu, izcedka iz ušesa in/ali okužbe ušesa se posvetujte s

svojim zdravnikom. To so lahko znaki poškodbe kosti v ušesu.

Neznana pogostnost:

Izguba las.

Motnje v delovanju jeter, v nekaterih primerih resne.

JAZMP-IA/051/G-01. 12. 2015

Redko se na začetku zdravljenja znižata koncentracija kalcija in fosfatov v krvi. Te spremembe so

običajno majhne in ne povzročajo simptomov.

Vrečice s kalcijem/vitaminom D

3

Občasni neželeni učinki

(pojavijo se lahko pri največ 1 od 100 bolnikov)

Hiperkalciemija (zvišana koncentracija kalcija v krvi, z možnimi simptomi prekomerne

žeje, izgube apetita, utrujenosti in v nekaterih primerih nerednega bitja srca), hiperkalciurija

(povečano izločanje kalcija z urinom).

Redki neželeni učinki

(pojavijo se lahko pri največ 1 od 1.000 bolnikov)

Zaprtje, vetrovi, siljenje na bruhanje, bolečine v trebuhu, driska.

Kožne reakcije, kot so srbenje, izpuščaj in koprivnica.

Poročanje o neželenih učinkih

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom. Posvetujte se tudi,

če opazite neželene učinke, ki niso navedeni v tem navodilu. O neželenih učinkih lahko poročate tudi

neposredno na Univerzitetni klinični center Ljubljana, Interna klinika, Center za zastrupitve, Zaloška

cesta 2, SI-1000 Ljubljana, Faks: + 386 (0)1 434 76 46, e-pošta: farmakovigilanca@kclj.si.

S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega

zdravila.

5.

Shranjevanje zdravila Actonel Combi

Zdravilo shranjujte nedosegljivo otrokom!

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg

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

Za shranjevanje zdravila niso potrebna posebna navodila.

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

zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom. Taki ukrepi pomagajo varovati okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Actonel Combi

Filmsko obložene tablete

Zdravilna učinkovina je natrijev risedronat. Vsaka tableta vsebuje 35 mg natrijevega risedronata, kar

ustreza 32,5 mg rizedronske kisline.

Pomožne snovi so:

Jedro tablete

: laktoza monohidrat (glejte poglavje 2), krospovidon A, magnezijev stearat in

mikrokristalna celuloza.

Filmska obloga:

hipromeloza, makrogol, hidroksipropilceluloza, brezvodni koloidni silicijev dioksid,

titanov dioksid [E171], rumeni železov oksid [E172] in rdeči železov oksid [E172].

Vrečice šumečih zrnc

Zdravilni učinkovini sta kalcijev karbonat in holekalciferol (vitamin D

). Vsaka vrečica šumečih zrnc

vsebuje 1000 mg kalcija kar ustreza 2.500 mg kalcijevega karbonata in 22 mikrogramov

(880 internacionalnih enot (i.e.) holekalciferola (vitamin D

JAZMP-IA/051/G-01. 12. 2015

Pomožne snovi so: citronska kislina, brezvodna, jabolčna kislina (malna kislina), glukonolakton,

maltodekstrin, natrijev ciklamat, natrijev saharinat, sorbitol [E420], manitol [E421], dekstrin, arabski

gumi, naravna olja limone, naravna aroma citronke, rižev škrob, kalijev karbonat, vseracemni-α-

tokoferol, sojino olje (hidrogenirano), želatina, saharoza in koruzni škrob.

Izgled zdravila Actonel Combi in vsebina pakiranja

Kombinirano pakiranje je sestavljeno iz zunanje ovojnine, ki vsebuje tedenska pakiranja (škatle).

Vsaka enota pakiranja zdravila Actonel Combi za enotedensko zdravljenje vsebuje:

eno filmsko obloženo tableto, ki je ovalne oblike in svetlooranžne barve ter ima na eni strani

oznako “RSN”, na drugi pa “35 mg”. Tableta je na voljo v pretisnem omotu.

6 vrečic šumečih zrnc s kalcijem in vitaminom D

Velikosti pakiranja: 1, 2, 4, 12 (3x4) in 16 (4x4) enot za enotedensko zdravljenje.

Na trgu ni vseh navedenih pakiranj.

Način izdaje zdravila Actonel Combi

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom in izdelovalec

Imetnik dovoljenja za promet z zdravilom:

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Islandija

Izdelovalec:

Warner Chilcott Deutschland GmbH,

Dr.-Otto-Röhm-Str. 2-4,

64331 Weiterstadt, Nemčija

Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na imetnika dovoljenja za

promet z zdravilom.

Zdravilo je dovoljenje za promet v deželah članicah EU pridobilo pod naslednjimi imeni:

Belgija:

Actonel Combi D 35 mg + 1000 mg / 880 IE filmomhulde tabletten +

bruisgranulaat, 35 mg + 1000 mg / 880 UI comprimé pelliculé et granulés

effervescents en sachet-dose, 35 mg + 1000 mg / 880 I.E. Filmtabletten +

Brausegranulat

Francija:

Actonel combi 35 mg + 1000 mg / 880 UI comprimé pelliculé et granulés

effervescents en sachet-dose

Nemčija:

Actonel plus Calcium D 35 mg + 1000 mg/880 I.E. Filmtabletten + Brausegranulat

Irska:

Actonel Plus Ca & D 35 mg film-coated tablets + 1000 mg / 880 i.u. effervescent

granules

Litva:

Actonel Combi 35 mg plėvele dengtos tabletės + 1000 mg / 880 TV šnypščiosios

granulės

Luksemburg:

Actonel Combi D 35 mg + 1000 mg / 880 UI comprimé pelliculé et granulés

effervescents en sachet-dose

Malta:

Actonel Plus Ca & D 35 mg film-coated tablets + 1000 mg / 880 i.u. effervescent

granules

Nizozemska:

Actokit D 35 mg + 1000 mg/880 IE filmomhulde tabletten + bruisgranulaat

Slovenija:

Actonel Combi 35 mg + 1000 mg/880 IE filmsko obložena tableta + šumeča zrnca

JAZMP-IA/051/G-01. 12. 2015

Švedska:

Optinate Combi D 35 mg + 1000 mg / 880 IE filmdragerade tabletter +

brusgranulat

Velika Britanija:

Actonel Combi 35 mg film-coated tablets + 1000 mg / 880 IU effervescent

granules

Navodilo je bilo nazadnje revidirano dne 01. 12. 2015.

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

15-10-2018

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Health Canada has determined that the slime and putty products do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

15-10-2018

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Health Canada's sampling and evaluation program has determined the Barrel-O-Slime toy does not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

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

29-10-2018

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7255 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1143/WS/1433/0050

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