FrancophonIA/ELRC3.0 huggingface dataset:
English: The most commonly reported adverse reactions, occurring in more than 5 % of patients treated with Remeron in randomized placebo-controlled trials (see below) are somnolence, sedation, dry mouth, weight increased, increase in appetite, dizziness and fatigue.
Slovenian: Najpogosteje so poročali o neželenih učinkih, ki so se pojavili pri več kot 5 % bolnikov, zdravljenih z zdravilom Remeron v randomiziranih s placebom nadzorovanih preskušanjih (glejte spodaj): somnolenca, sedacija, suha usta, povečana telesna masa, povečanje teka, omotica in utrujenost.
English: The carton contains one brown (type III) glass bottle containing 66 ml of Remeron oral solution and one metering pump.
Slovenian: Škatla vsebuje eno stekleničko iz rjavega stekla (tipa III) s 66 ml zdravila Remeron peroralna raztopina in eno odmerno črpalko.
English: → Stop taking Remeron and tell your doctor straight away.
Slovenian: → Prenehajte jemati zdravilo Remeron in nemudoma obvestite svojega zdravnika.
English: The CHMP considered that the arguments provided by the applicant/MAH were insufficient to justify that mirtazapine would act different from SSRIs and SNRIs (e.g. venlafaxine).
Slovenian: CHMP je menil, da argumenti predloženi s strani predlagatelja/imetnika dovoljenja za promet z zdravilom niso ustrezno upravičili trditve, da bi mirtazapin deloval drugače kot selektivni zaviralci ponovnega privzema serotonina (SSRIs) in zaviralci privzema serotonina/noradrenalina (SNRIs) (to je venlafaksin).
English: If you are supposed to take your dose once a day
Slovenian: Če jemljete odmerek zdravila enkrat na dan:
English: After taking the pump out of the plastic bag it should be fitted onto the bottle by carefully inserting the plastic tube into the bottle opening.
Slovenian: Črpalko vzemite iz plastične vrečke in jo postavite na stekleničko tako, da previdno vstavite plastično cevko v odprtino stekleničke.
English: - Interaction studies did not indicate any relevant pharmacokinetic effects on concurrent treatment of mirtazapine with paroxetine, amitriptyline, or risperidone or lithium.
Slovenian: - Študije medsebojnega delovanja niso pokazale nobenih relevantnih farmakokinetičnih učinkov pri sočasnem zdravljenju z mirtazapinom in paroksetinom, amitriptilinom, ali risperidonom ali litijem.
English: Since the mechanism of interaction is different for MAO-Is with mirtazapine compared to MAO-Is and SSRIs, it is unlikely that the risk of serotonin syndrome is as high as with other serotonergic antidepressants, such as SSRIs.
Slovenian: Ker je mehanizem medsebojnega delovanja pri zaviralcih monoaminskih oksidaz (MAOIs) z mirtazapinom drugačen kot pri medsebojnem delovanju zaviralcev monoaminskih oksidaz (MAOIs) in selektivnih zaviralcev ponovnega privzema serotonina (SSRIs), je verjetnost serotoninskega sindrom enako visoka kot pri drugih serotonergičnih antidepresivih, kot so na primer selektivni zaviralci ponovnega privzema serotonina.
English: ‘Prime' the metering pump before you take Remeron The very first time you press the pump, it will not measure out the right amount of Remeron solution.
Slovenian: Pred jemanjem zdravila Remeron ‘napolnite' odmerno črpalko Ko na črpalko prvič pritisnete, ne bo izmerila pravilne količine zdravila Remeron peroralna raztopina, zato jo morate pred prvim odmerjanjem napolniti.
English: However, if you are an elderly person or if you have renal or liver disease, your doctor may adapt the dose.
Slovenian: Odmerek je običajno enak za vse starosti, če pa sodite med starostnike ali če imate ledvično ali jetrno bolezen, vam bo zdravnik morda prilagodil odmerek zdravila.
English: Remeron 15, 30 and 45 mg film-coated tablets are packed in blisters or bottles.
Slovenian: Zdravilo Remeron 15, 30 in 45 mg filmsko obložene tablete je pakirano v pretisne omote ali stekleničke.
English: • medicines for anxiety or insomnia such as benzodiazepines; medicines for schizophrenia such as olanzapine; medicines for allergies such as cetirizine; medicines for severe pain such as morphine.
Slovenian: • zdravila proti tesnobi ali nespečnosti, na primer benzodiazepini; zdravila za shizofrenijo, na primer olanzapin; zdravila za alergije, na primer cetirizin; zdravila za hude bolečine, na primer morfin.
English: Press the pump onto the top of the bottle, and turn it clockwise until it clicks tightly into place.
Slovenian: Črpalko pritisnite na vrh stekleničke in jo trdno privijte, dokler ne zaslišite klika.
English: In Sections 4.3 (Contra-indications) and 4.5 (Interaction with other medicinal products and forms of interaction) of the SPC, the interaction with MAOIs concerns an absolute contra-indication in accordance with the SPCs for SSRIs and SNRIs.
Slovenian: V razdelkih 4.3 (Kontraindikacije) in 4.5 (Medsebojno delovanje z drugimi zdravili in druge oblike interakcij) povzetka glavnih značilnosti zdravila, medsebojno delovanje z zaviralci monoaminskih oksidaz (MAO) je zadeva absolutne kontraindikacije v skladu z povzetki glavnih značilnosti zdravil s selektivnimi zaviralci ponovnega privzema serotonina (SSRIs) in zaviralci privzema serotonina/noradrenalina (SNRIs).
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suiciderelated events).
Slovenian: Samomor, samomorilne misli in poslabšanje kliničnega stanja Depresija je povezana s večjim tveganjem za pojav samomorilnih misli, samopoškodovanja in samomorilnosti (s samomorom povezanimi dogodki).
English: If you use Remeron until, or shortly before birth, your baby should be supervised for possible adverse effects.
Slovenian: Če jemljete zdravilo Remeron do poroda ali skoraj do poroda, bo potreben nadzor vašega otroka zaradi možnih neželenih učinkov.
English: • signs of infection such as sudden inexplicable high fever, sore throat and mouth ulcers (agranulocytosis) → Stop taking Remeron and contact your doctor straight away for a blood test.
Slovenian: • znaki okužbe, na primer nenaden pojav nepojasnjene visoke telesne temperature, vnetja žrela in razjed v ustih (agranulocitoza) → Prenehajte jemati zdravilo Remeron in nemudoma obvestite svojega zdravnika, da bo opravil ustrezno krvno preiskavo.
English: Thyroid gland tumours found in a rat carcinogenicity study and hepatocellular neoplasms found in a mouse carcinogenicity study are considered to be species-specific, non-genotoxic responses associated with long-term treatment with high doses of hepatic enzyme inducers.
Slovenian: Menijo, da so tumorji žleze ščitnice, ki so jih ugotovili v študiji kancerogenosti zdravila pri podganah, in hepatocelularne neoplazme, ki so jih ugotovili v študiji kancerogenosti zdravila pri miših, značilni izključno za ti dve živalski vrsti in da gre v teh primerih za odziv, ki ni genotoksičen, ampak je povezan z dolgotrajnim prejemanjem velikih odmerkov snovi, ki inducirajo jetrne encime.
English: Limited experience with Remeron administration to pregnant women does not indicate an increased risk.
Slovenian: Dosedanje omejene izkušnje z uporabo zdravila Remeron pri nosečnicah ne kažejo na povečano tveganje.
English: Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Slovenian: Da bodo simptomi depresije zagotovo minili, morajo biti bolniki zdravljeni zadosti dolgo, najmanj pa 6 mesecev.
English: • Place the bottle on a flat surface.
Slovenian: • Stekleničko postavite na ravno površino.
English: What Remeron looks like and contents of the pack
Slovenian: Izgled zdravila Remeron in vsebina pakiranja
English: • if you develop signs of infection such as inexplicable high fever, sore throat and mouth ulcers.
Slovenian: • če se pri vas pojavijo znaki okužbe, na primer nepojasnjena visoka telesna temperatura, vnetje žrela ali razjede v ustih.
English: Therefore, the following wording on pharmacodynamic interactions for Section 4.5 of the SPC was recommended:
Slovenian: Za povzetek glavnih značilnosti zdravila v razdelku 4.5 je tako za farmakodinamične interakcije priporočeno naslednje besedilo:
English: Mirtazapine
Slovenian: Mirtazapin
English: SPC Section 4.5 Special Warnings and precautions for use
Slovenian: Povzetek glavnih značilnosti zdravila, razdelek 4.5: Posebna opozorila in previdnostni ukrepi pri uporabi
English: N.V. Organon, Kloosterstraat 6, P.O.
Slovenian: Organon, Kloosterstraat 6, P.O. Box
English: - Care should be taken in patients with micturition disturbances like prostate hypertrophy and in patients with acute narrow-angle glaucoma and increased intra-ocular pressure (although there is little chance of problems with Remeron because of its very weak anticholinergic activity).
Slovenian: - Pri bolnikih z motnjami uriniranja kot so hipertrofija prostate, pa tudi pri tistih, ki imajo glavkom ozkega zakotja in povišan očesni tlak, je potrebna previdnost (čeprav je malo možnosti, da se bodo pojavile težave pri jemanju zdravila Remeron, ker je njegovo antiholinergično delovanje zelo šibko).
English: Remeron 15, 30 and 45 mg film-coated tablets are packed in blisters made of opaque polyvinyl chloride film and aluminium foil containing a heat-seal coating on the side in contact with the filmcoated tablets.
Slovenian: Zdravilo Remeron 15, 30 in 45 mg filmsko obložene tablete je pakirano v za otroke varne pretisne omote, izdelane iz neprozorne bele polivinilkloridne folije in iz aluminijaste folije, ki ima termoskrčljivo oblogo na strani, ki je v stiku s filmsko obloženimi tabletami.
English: The frequency of adverse reactions from spontaneous reporting for which no cases in the randomized placebo-controlled patient trials were observed with mirtazapine has been classified as ‘not known'.
Slovenian: Za neželene učinke iz spontanega poročanja, pri katerih ni bilo nobenih primerov v randomiziranih in s placebom nadzorovanih preskušanjih pri bolnikih, ki so jemali mirtazapin, je pogostnost opisana kot ‘pogostnost neznana'.
English: The clearance of mirtazapine may be decreased in patients with moderate to severe renal impairment (creatinine clearance <40 ml/min).
Slovenian: Očistek mirtazapina je lahko zmanjšan pri bolnikih z zmerno do hudo ledvično okvaro (očistek kreatinina < 40 ml/min).
English: BEFORE YOU TAKE REMERON Take care when taking Remeron in combination with:
Slovenian: PRED UPORABO ZDRAVILA REMERON Bodite pozorni, če jemljete zdravilo Remeron v kombinaciji z naslednjimi zdravili:
English: The amount of phenylalanine is low in Remeron orodispersible tablets.
Slovenian: Količina fenilalanina v zdravilu Remeron, orodisperzibilnih tabletah, je zelo majhna.
English: Pharmacokinetic interactions - Carbamazepine and phenytoin, CYP3A4 inducers, increased mirtazapine clearance about twofold, resulting in a decrease in average plasma mirtazapine concentration of 60 % and 45 %, respectively.
Slovenian: Farmakokinetične interakcije - Karbamazepin in fenitoin, ki sta oba induktorja encima CYP3A4, sta povečala očistek mirtazapina za približno dvakrat in tako povzročila zmanjšanje plazemske koncentracije mirtazapina, pri karbamazepinu za 60 % in pri fenitoinu za 45 %.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Remeron.
Slovenian: Zdravnika tudi obvestite, če se pri bolniku, ki je mlajši od 18 let in jemlje zdravilo Remeron, pojavi ali poslabša kateri od zgoraj naštetih simptomov.
English: At that time, in 1989, the cut-off values for the level of renal impairment were in line with FDA draft Guidance for Industry on “Pharmacokinetics and Pharmacodynamics in patients with Impaired renal function: study design, data analysis, and impact on dosing and labelling”.
Slovenian: Presečne vrednosti so bile v letu 1989 za različne stopnje ledvičnih obolenj v skladu z osnutkom Urada za živila in zdravila ZDA Smernice za industrijo za „Farmakokinetiko in farmakodinamiko pri bolnikih z omejenim delovanjem ledvic: načrtovanje študije, analiza podatkov, vpliv na odmerjanje in označevanje.“ Zaradi tega je presečna vrednost določena pri 40 ml/min/1,73 m2.
English: Preparing the metering pump for dosing
Slovenian: Priprava odmerne črpalke za odmerjanje
English: 6 Cases of suicidal ideation and suicidal behaviours have been reported during mirtazapine therapy or early after treatment discontinuation (see section 4.4).
Slovenian: 6 Med zdravljenjem ali kmalu po prenehanju zdravljenja z mirtazapinom so bili opaženi primeri razmišljanja o samomoru in samomorilno obnašanje (glejte poglavje 4.4).
English: After a click, there should be one final tightening to ensure that the pump is securely screwed in place.
Slovenian: Po kliku napravite še en, zadnji obrat, da bo črpalka trdno stala na steklenički.
English: • monoamine oxidase inhibitors (MAO inhibitors).
Slovenian: • zaviralci monoaminooksidaze (zaviralci MAO).
English: Remeron oral solution is a clear, colourless - to pale yellow solution with a citrus-orange odour.
Slovenian: Remeron peroralna raztopina je bistra in brezbarvna do bledo rumena raztopina z vonjem po limonah in pomarančah.
English: The following pack sizes are available for each strength: 6 (1x6), 18 (3x6), 30 (5x6), 48 (8x6) and 96 (16x6) and 180 (10x18 (3x6)) orodispersible tablets.
Slovenian: Na voljo so naslednje velikosti pakiranj za vsako jakost: 6 (1x6), 18 (3x6), 30 (5x6), 48 (8x6) in 96 (16x6) in 180 (10x18 (3x6)) orodisperzibilnih tablet.
English: Treatment with an adequate dose should result in a positive response within 2-4 weeks.
Slovenian: Pri uporabi ustreznega odmerka naj bi dosegli pozitiven odziv v 2 do 4 tednih, pri nezadostnem odzivu pa lahko odmerek povečate do največjega odmerka.
English: Taking Remeron with food and drink You may get drowsy if you drink alcohol while you are taking Remeron.
Slovenian: Unknown document property name. skupaj s hrano in pijačo Če boste med jemanjem zdravila Remeron uživali alkohol, boste lahko postali zaspani.
English: It is therefore sometimes difficult to ascertain which symptoms are a result of the illness itself and which are a result of treatment with Remeron.
Slovenian: Bolniki z depresijo imajo več simptomov, ki so povezani s samo boleznijo, zato je včasih težko oceniti, kateri simptomi so posledica osnovne bolezni in kateri se pojavljajo zaradi zdravljenja z zdravilom Remeron.
English: The applicant/MAH stated that there are no data indicating that mirtazapine aggravates conditions where blood count is altered.
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom navaja, da ne obstajajo nobeni podatki o vplivu mirtazapina na spremembe krvne slike.
English: • feeling elated or emotionally ‘high' (mania)
Slovenian: • občutek vznesenosti ali čustvenega opoja (manija)
English: The carton contains one brown glass bottle with 66 ml of Remeron oral solution and one metering pump.
Slovenian: Škatla vsebuje eno rjavo stekleničko s 66 ml zdravila Remeron peroralna raztopina in eno odmerno črpalko.
English: GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: PODLAGA ZA DOPOLNITEV POVZETKA(OV) GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
English: Using the metering pump to dispense the oral solution The nozzle has two positions and can be turned gently - anti-clockwise (unlocked position) and clockwise (locked position).
Slovenian: Uporaba odmerne črpalke za odmerjanje peroralne raztopine Šoba ima dva položaja in jo lahko previdno obračate nasprotno smeri urinega kazalca (odprt položaj) in v smeri urinega kazalca (zaprt položaj).
English: • restless legs
Slovenian: • nemirne noge
English: If Remeron is used until, or shortly before birth, postnatal monitoring of the newborn is recommended to account for possible discontinuation effects.
Slovenian: Če bolnica jemlje zdravilo Remeron do poroda ali skoraj do poroda, je priporočljivo spremljati novorojenčka, da bi ugotovili morebitne odtegnitvene učinke.
English: • abnormal sensations in the mouth (oral paraesthesia)
Slovenian: • nenormalni občutki v ustih (parestezije v ustih)
English: Tablet core: maize starch, hyprolose, magnesium stearate, silica, colloidal anhydrous, lactose monohydrate
Slovenian: Jedro tablete: koruzni škrob, hiproloza, magnezijev stearat, silicijev dioksid, brezvodni, koloidni, laktoza monohidrat
English: The applicant/ MAH also agreed to include the interaction with MAOIs in section 4.3 of the SPC:
Slovenian: Predlagatelj/imetnik dovoljenja za promet z zdravilom je pristal tudi na vključitev medsebojnega delovanja z zaviralci monoaminskih oksidaz (MAO) v razdelku 4.3 povzetka glavnih značilnosti zdravila:
English: Remeron are film-coated tablets.
Slovenian: Zdravilo Remeron so filmsko obložene tablete.
English: 1 ml of Remeron oral solution contains 700 mg maltitol liquid.
Slovenian: 1 ml zdravila Remeron peroralna raztopina vsebuje 700 mg tekočega maltitola.
English: Frequency not known and administration site conditions peripheral1 Fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije periferni edem1
English: Remeron oral solution comes with a metering pump to help you measure your dose.
Slovenian: Zdravilo Remeron peroralna raztopina ima priloženo črpalko, s katero boste lahko izmerili odmerek.
English: Store in the original package in order to protect from light and moisture
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.
English: The solution should be taken orally, in a glass containing some water.
Slovenian: Raztopino naj bolnik jemlje peroralno, v kozarcu z nekaj vode.
English: Mirtazapine Zispin® film-coated tablets
Slovenian: Mirtazapine Zispin® filmcoated tablets
English: During clinical research with Remeron, undesirable effects have not been reported more often in elderly patients than in other age groups.
Slovenian: Starejši bolniki so pogosto bolj občutljivi, še posebej kar zadeva neželene učinke antidepresivov, vendar pa med kliničnimi raziskavami z zdravilom Remeron niso pogosteje poročali o neželenih učinkih pri starejših bolnikih kot pri bolnikih iz drugih starostnih skupin.
English: → If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Slovenian: → Če kadarkoli začnete razmišljati o samopoškodovanju ali samomoru, se nemudoma posvetujte s svojim zdravnikom ali poiščite pomoč v najbližji bolnišnici.
English: • swelling in the mouth (mouth oedema)
Slovenian: • otekanje v ustih (edem ust)
English: - Interaction studies did not indicate any relevant pharmacokinetic effects on concurrent treatment of mirtazapine with paroxetine, amitriptyline, risperidone or lithium.
Slovenian: - Študije interakcij z drugimi zdravili niso pokazale pomembnih farmakokinetičnih učinkov pri sočasnem zdravljenju z mirtazapinom in paroksetinom, amitriptilinom, risperidonom ali litijem.
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Remeron and associated names (see Annex I).
Slovenian: je Odbor za zdravila za uporabo v humani medicini (CHMP) priporočil dopolnitev dovoljenja za promet z zdravilom Remeron in z njim povezanih imen, za katera so v Dodatku III določeni povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo (glejte Dodatek I).
English: The average plasma concentration of mirtazapine was about 55 % and 115 % increased respectively.
Slovenian: Povprečna plazemska koncentracija mirtazapina se je povečala za približno 55 % oziroma za 115 %.
English: Produtos Químicos e Farmacêuticos, Lda Av. José Malhoa, 16-B -2º 1070-159 Lisboa Portugal
Slovenian: Produtos Químicos e Farmacêuticos, Lda Av. José Malhoa, 16-B -2º
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, carcinogenicity or genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, kancerogenega potenciala ali genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: After oral administration of Remeron, the active substance mirtazapine is rapidly and well absorbed (bioavailability ≈ 50 %), reaching peak plasma levels after approx. one hour.
Slovenian: Po peroralni uporabi zdravila Remeron se njegova zdravilna učinkovina mirtazapin hitro in dobro absorbira (biološka uporabnost ≈ 50 %) in doseže največjo plazemsko koncentracijo po približno eni uri.
English: The clearance of mirtazapine may be decreased as a result of renal or hepatic impairment.
Slovenian: Očistek mirtazapina je lahko zmanjšan pri ledvični ali jetrni okvari.
English: Clear, colourless-to-straw aqueous solution with a characteristic citrus-orange odour.
Slovenian: Bistra, brezbarvna do rumenkasta vodna raztopina z značilnim vonjem po limonah in pomarančah.
English: • Very rare:
Slovenian: • Zelo redki:
English: Interaction with serotonergic active substances: serotonin syndrome may occur when selective serotonin reuptake inhibitors (SSRIs) are used concomitantly with other serotonergic active substances (see section 4.5).
Slovenian: Medsebojno delovanje zdravila s serotoninergičnimi zdravilnimi učinkovinami: Pri sočasnem jemanju selektivnih zaviralcev ponovnega privzema serotonina (SSRI) in drugih serotoninskih zdravilnih učinkovin lahko nastopi serotoninski sindrom (glejte poglavje 4.5).
English: • sensations of numbness in the mouth (oral hypoaesthesia)
Slovenian: • občutek odrevenelosti v ustih (hipoestezija ust)
English: • increase in appetite and weight gain
Slovenian: • povečanje teka in pridobivanje telesne mase
English: Take the orodispersible tablet as follows Take your tablets orally.
Slovenian: Kako jemati orodisperzibilno tableto : Tablete jemljite peroralno.
English: Place the bottle on a flat surface.
Slovenian: Stekleničko postavite na ravno površino.
English: In the opposite way about two weeks should pass before patients treated with mirtazapine should be treated with MAO inhibitors (see section 4.3).
Slovenian: Velja pa tudi obratno, namreč da morata preteči približno dva tedna, preden lahko bolnike, ki so se zdravili z mirtazapinom, začnete zdraviti z zaviralci MAO (glej poglavje 4.3).
English: Each Remeron 45 mg orodispersible tablet contains 13.95 mg aspartame and 84 mg sucrose.
Slovenian: Ena Remeron 45 mg orodisperzibilna tableta vsebuje 13,95 mg aspartama in 84 mg saharoze.
English: These do not include hereditary deficiencies of amino acid (phenylalanine) metabolism, such as phenylketonuria.
Slovenian: Medtem ko dedne nepravilnosti presnavljanja aminokislin (fenilalanin), kot je na primer fenilketonurija, niso vključene.
English: What Remeron contains
Slovenian: Kaj vsebuje zdravilo Remeron
English: Each Remeron 15 mg orodispersible tablet contains 4.65 mg aspartame and 28 mg sucrose.
Slovenian: Ena Remeron 15 mg orodisperzibilna tableta vsebuje 4,65 mg aspartama in 28 mg saharoze.
English: After oral administration of Remeron, the active substance mirtazapine is rapidly and well absorbed (bioavailability ≈ 50 %), reaching peak plasma levels after approx. two hours.
Slovenian: Po peroralni uporabi zdravila Remeron se njegova zdravilna učinkovina mirtazapin hitro in dobro absorbira (biološka uporabnost ≈ 50 %) in doseže največjo plazemsko koncentracijo po približno dveh urah.
English: Applying the metering pump to the bottle
Slovenian: Postavitev odmerne črpalke na stekleničko
English: On 14 February 2007 a combined renewal via MRP was concluded for Remeron film-coated tablets 45 mg, Remeron 15, 30, 45 mg, Remeron oral solution 15 mg/ml, Mirtazapine orodispersible tablets 15, 30, 45 mg., involving in total 8 Member States, including the Reference Member State (RMS).
Slovenian: S postopkom medsebojnega priznavanja je bil 14. februarja 2007 zaključen združeni obnovitveni postopek, pri katerem je sodelovalo 8 držav članic, vključno z referenčno državo članico, za zdravila Remeron, filmsko obložene tablete 45 mg, Remeron 15, 30, 45 mg, Remeron peroralna raztopina 15 mg/ml in Mirtazapine orodisperzibilne tablete 15, 30, 45 mg. Predlog podjetja za povzetek glavnih značilnosti zdravila je v večini zasnovan na tem postopku medsebojnega priznavanja.